37 results on '"Szczotka-Flynn LB"'
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2. Risk Factors for Bacterial Keratitis and Severe Disease in Hydrogel Contact Lens Users: A Multicenter Case-Control Study and Case-Only Analysis.
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Szczotka-Flynn LB, Raghupathy S, Shah S, Suri K, Briggs F, and Iyengar SK
- Abstract
Purpose: To assess risk factors for contact lens (CL)-related bacterial keratitis, cases and high-risk controls were enrolled. Using high-risk controls can help elucidate whether certain CL types or modalities are attributable to disease burden if risky wear patterns are similar between the cases and controls. This analysis identified whether such CL factors were associated with the occurrence of bacterial keratitis. In addition, a case-only analysis determined CL factors associated with severe disease., Methods: From 2018 to 2021, 158 controls were enrolled at University Hospitals of Cleveland Eye Institute, and 153 bacterial keratitis cases were enrolled across 14 sites in the United States. Cases were soft CL wearers with either culture-proven bacterial keratitis or a corneal infiltrate with an overlying epithelial defect within the central 4 mm of the cornea, uveitis, or significant pain. Fungal, protozoan, or nonsoft CL wear-related microbial keratitis cases were excluded. Controls were recruited from high-risk CL wearers with no history of disease. All participants completed a questionnaire related to demographics, type of CL used, wearing schedule, lens handling practices, and storage case handling. Cases with ulcer/infiltrate size ≥2 mm in size, presence of hypopyon, or had fortified antibiotics prescribed were classified as severe keratitis. Univariate and multivariable logistic regression was used to assess association of CL variables with the occurrence of bacterial keratitis as well as occurrence of severe disease among the cases only., Results: Compared with the control cohort, cases were older (mean age 45.6 vs. 38.9 years), had more males (42.5% vs. 23.6%), and had more current or former smokers (41.7% vs. 12.9%). There were no significant associations between CL material (silicone hydrogel vs. not) or CL type (daily disposable vs. reusable) and occurrence of bacterial keratitis. More than two-thirds (67.3%) of cases were classified as severe. Among cases only, univariate analyses found current smokers to have increased risk of severe disease (OR=2.87; 95% CI 1.13-7.26, P=0.03). Adjusting for age, sex, and smoking among the cases only, daily disposable lenses were protective against severe disease (OR=0.32; 95% CI 0.11-0.89, P=0.03). Reusable lenses increased risk of severe microbial keratitis between 3.0- and 4.4-fold compared with compliant daily disposability., Discussion/conclusion: Compared with a high-risk control cohort, no specific lens factors were associated with occurrence of CL-associated bacterial keratitis. Among cases only, current smokers and patients wearing reusable lenses are at increased risk of severe keratitis. Daily disposable lenses were protective even when noncompliance to daily disposability was considered., (Copyright © 2024 Contact Lens Association of Ophthalmologists.)
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- 2024
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3. Comparison of Graft Outcomes Reusing Original Intermediate-Term Cold Storage Solution for Entire Corneal Donor Storage Period With Exchanged Fresh Storage Solution After Donor Preparation in the Cornea Preservation Time Study.
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Lass JH, Bailey RJ, Szczotka-Flynn LB, Benetz BA, Soper M, Titus MS, Kollman C, and Beck RW
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- Humans, Time and Motion Studies, Cornea surgery, Eye Banks, Tissue Donors, Endothelium, Corneal, Descemet Stripping Endothelial Keratoplasty, Fuchs' Endothelial Dystrophy surgery
- Abstract
Purpose: The purpose of this study was to evaluate outcomes of Descemet stripping automated endothelial keratoplasty comparing exchange with fresh intermediate-term cold storage solution after lenticule preparation versus reuse of the original solution in the Cornea Preservation Time Study., Methods: In the Cornea Preservation Time Study, 508 donor corneas had lenticules prepared by the eye bank with fresh solution exchange (Fresh group) and 283 with reuse of the original solution (Original group). Storage time for all donors was ≤11 days. Graft success rates, central endothelial cell loss at 3 years, and frequency of positive donor rim cultures were compared between the 2 groups., Results: The 3-year graft success rate (95% confidence interval) was 93.4% (90.7%-95.3%) in the Fresh group and 95.2% (91.8%-97.2%) in the Original group (adjusted hazard ratio for graft failure = 0.64, 95% confidence interval, 0.33-1.24, P = 0.19). The mean percentage endothelial cell loss was significantly greater in the Fresh group versus Original group (45% ± 22% vs. 38% ± 20%, respectively, P = 0.004). Cultures were positive in 4 (1.5%) of 267 donor rims (3 fungal and 1 bacterial) in the Fresh group and in 4 (2.5%) of 158 in the Original group ( P = 0.57). There were 2 postoperative infections in the Original group and none in the Fresh group., Conclusions: The use of the original intermediate-term cold storage solution did not reduce the 3-year graft success rate compared with exchanging with fresh solution after lenticule preparation for Descemet stripping automated endothelial keratoplasty, while the frequency of positive donor rim cultures did not significantly differ between groups., Competing Interests: The following authors have financial disclosures with companies that manufacture corneal storage solutions (considered relevant to this work): M. Terry (Bausch & Lomb) and W. B. Lee (Bausch & Lomb) (part of CPTS Study Group but not authors on this paper). These authors are employed by eye banks: M. Soper (VisionFirst), and M. S. Titus (Eversight). J. H. Lass is a voluntary board member of Eversight and the Cleveland Eye Bank Foundation. The remaining authors have no conflicts of interest to disclose., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2022
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4. Authors' Reply: "Thirty years of 'quiet eye' with etafilcon A contact lenses: Additional considerations".
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Efron N, Brennan NA, Chalmers RL, Jones L, Lau C, Morgan PB, Nichols JJ, Szczotka-Flynn LB, and Willcox MD
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- Humans, Contact Lenses, Methacrylates
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- 2021
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5. A Clarification and Call for a National Keratoplasty Registry.
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O'Brien RC, Szczotka-Flynn LB, and Lass JH
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- 2021
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6. American Academy of Optometry Microbial Keratitis Think Tank.
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Szczotka-Flynn LB, Shovlin JP, Schnider CM, Caffery BE, Alfonso EC, Carnt NA, Chalmers RL, Collier S, Jacobs DS, Joslin CE, Kroken AR, Lakkis C, Pearlman E, Schein OD, Stapleton F, Tu E, and Willcox MDP
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- Academies and Institutes, Acanthamoeba Keratitis parasitology, Epidemiologic Studies, Eye Infections, Bacterial microbiology, Eye Infections, Fungal microbiology, Eye Infections, Parasitic parasitology, Humans, Incidence, Keratitis microbiology, Risk Factors, United States epidemiology, Acanthamoeba Keratitis epidemiology, Contact Lenses adverse effects, Eye Infections, Bacterial epidemiology, Eye Infections, Fungal epidemiology, Eye Infections, Parasitic epidemiology, Keratitis epidemiology, Optometry organization & administration
- Abstract
Significance: Think Tank 2019 affirmed that the rate of infection associated with contact lenses has not changed in several decades. Also, there is a trend toward more serious infections associated with Acanthamoeba and fungi. The growing use of contact lenses in children demands our attention with surveillance and case-control studies., Purpose: The American Academy of Optometry (AAO) gathered researchers and key opinion leaders from around the world to discuss contact lens-associated microbial keratitis at the 2019 AAO Annual Meeting., Methods: Experts presented within four sessions. Session 1 covered the epidemiology of microbial keratitis, pathogenesis of Pseudomonas aeruginosa, and the role of lens care systems and storage cases in corneal disease. Session 2 covered nonbacterial forms of keratitis in contact lens wearers. Session 3 covered future needs, challenges, and research questions in relation to microbial keratitis in youth and myopia control, microbiome, antimicrobial surfaces, and genetic susceptibility. Session 4 covered compliance and communication imperatives., Results: The absolute rate of microbial keratitis has remained very consistent for three decades despite new technologies, and extended wear significantly increases the risk. Improved oxygen delivery afforded by silicone hydrogel lenses has not impacted the rates, and although the introduction of daily disposable lenses has minimized the risk of severe disease, there is no consistent evidence that they have altered the overall rate of microbial keratitis. Overnight orthokeratology lenses may increase the risk of microbial keratitis, especially secondary to Acanthamoeba, in children. Compliance remains a concern and a significant risk factor for disease. New insights into host microbiome and genetic susceptibility may uncover new theories. More studies such as case-control designs suited for rare diseases and registries are needed., Conclusions: The first annual AAO Think Tank acknowledged that the risk of microbial keratitis has not decreased over decades, despite innovation. Important questions and research directions remain., Competing Interests: Conflict of Interest Disclosure: All participants were paid by the American Academy of Optometry to participate. The following authors report financial interests, but none of these sponsors provided financial or other support and had no involvement in this report: ECA, Alcon Laboratories, Alcon Research Institute, and Salvat Laboratories; CL, Johnson & Johnson Vision Care, Source One Technical Solutions, Scigofer, and CooperVision; NAC, Alcon, Johnson & Johnson, CooperVision, Specsavers, and Luxottica; DSJ, TECLens, Inc., and Simple Contacts; CEJ, Johnson & Johnson Vision Care, Inc.; CMS, Johnson & Johnson Vision Care; JPS, AbbVie, Aerie Pharmaceuticals, Dompe, LensTech, and Novartis; FS, Alcon Laboratories, Azura Ophthalmics, Nthalmic, Menicon, Novartis, and Sequirus; LBS-F, Johnson & Johnson Vision Care, Alcon, and LensTech; and MDPW, Johnson & Johnson Medical Pty Ltd., Johnson & Johnson Vision Care Inc., CooperVision, Allergan, Alcon Laboratories, and Ophtecs Corp., (Copyright © 2021 American Academy of Optometry.)
- Published
- 2021
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7. Random Survival Forests Analysis of Intraoperative Complications as Predictors of Descemet Stripping Automated Endothelial Keratoplasty Graft Failure in the Cornea Preservation Time Study.
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O'Brien RC, Ishwaran H, Szczotka-Flynn LB, and Lass JH
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- Adult, Aged, Aged, 80 and over, Corneal Edema diagnosis, Double-Blind Method, Female, Fuchs' Endothelial Dystrophy diagnosis, Humans, Machine Learning, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Failure, United States, Corneal Edema surgery, Decision Support Techniques, Descemet Membrane surgery, Descemet Stripping Endothelial Keratoplasty adverse effects, Endothelium, Corneal transplantation, Fuchs' Endothelial Dystrophy surgery, Graft Survival, Intraoperative Complications etiology
- Abstract
Importance: A new analytic method can evaluate factors of interest associated with graft failure after Descemet stripping automated endothelial keratoplasty (DSAEK) or more generally in any ophthalmic surgical setting with a time-to-event outcome., Objective: To reanalyze types of intraoperative complications associated with DSAEK graft failure in the Cornea Preservation Time Study using random survival forests., Design, Setting, and Participants: This cohort study, initially conceived in April 2019, used a prediction model to conduct a post hoc secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. The study included 1090 participants, representing 1330 eyes, undergoing DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic or aphakic corneal edema (75 eyes [5.6%]). Enrollment occurred between April 16, 2012, and February 20, 2014, and follow-up ended June 5, 2017. Statistical analysis was performed from July 10, 2019, to May 29, 2020., Intervention: Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with preservation time of 7 days or less or 8 to 14 days., Main Outcomes and Measures: Ranked variable importance for intraoperative complications among 50 donor, recipient, and eye bank variables and restricted mean survival time through 47 months (1434 days) after DSAEK were examined. Random survival forests, a nonparametric method (with less restrictive model assumptions) that is far more flexible in its ability to model nonlinear effects and interactions, was used to analyze the data., Results: This study included 1090 participants (663 women [60.8%]; median age, 70 years [range, 42-90 years]), representing 1330 eyes. Random survival forests ranked a DSAEK intraoperative complication as the third most predictive factor of graft failure, after surgeon and eye bank, in the final model with 5 predictors. In the first 47 months after DSAEK, the estimated mean difference in restricted mean survival time for grafts that experienced a DSAEK intraoperative complication vs those that did not was -227 days (99% CI, -352 to -70 days) based on the final RSF model., Conclusions and Relevance: These findings, while post hoc, support the hypothesis that random survival forests allow for an improved analytic approach for identifying factors predictive of graft failure and for obtaining adjusted graft survival estimates. Random survival forests offer the opportunity to guide the development of future population-based cohort ophthalmic surgical studies, establishing definitive factors for procedural success.
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- 2021
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8. Acute corneal edema decades after penetrating keratoplasty for keratoconus in eyes wearing scleral contact lenses.
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Murillo SE, Shariff A, Lass JH, and Szczotka-Flynn LB
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- Cornea, Edema, Humans, Keratoplasty, Penetrating adverse effects, Retrospective Studies, Contact Lenses adverse effects, Corneal Edema diagnosis, Corneal Edema etiology, Keratoconus diagnosis, Keratoconus surgery
- Abstract
Purpose: To report three cases of acute corneal edema occurring decades after penetrating keratoplasty (PK) for keratoconus in eyes wearing scleral contact lenses (ScCLs) with previously clear corneal grafts., Methods: Retrospective chart review of three ScCL wearers presenting for sudden onset pain and blurred vision. Data extracted included clinical presentation, year and reason for PK, ocular medications and comorbidities, contact lens wearing history, results of any ancillary testing available including corneal topography, anterior segment optical coherence tomography (OCT), and specular microscopy surrounding the event, treatment and outcomes of intervention. The number of PK eyes fit with ScCLs in the author's practice was determined to estimate the prevalence of this event., Results: The three patients each had a longstanding PK for keratoconus performed between 33-35 years prior to presentation and recurrent ectasia. Each patient presented with an acute, painful eye and reduced vision either 3 days, 4 months or 9 years after refitting into ScCLs. Each eye had well demarcated focal microcystic epithelial and stromal edema within the graft and crossing the wound margin onto the host cornea. Although a definitive break or detachment of Descemet's membrane was not visualized, the presentations suggest these were episodes of acute hydrops., Conclusions: Longstanding PKs with recurrent ectasia and acute focal edema suggestive of corneal hydrops is demonstrated in this case series of ScCL wearers. Although similar events have occurred as part of the natural history of post-PK corneas for keratoconus, the proximity of ScCL refitting to two of the events suggests some association., (Copyright © 2020. Published by Elsevier Ltd.)
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- 2021
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9. Thirty years of 'quiet eye' with etafilcon A contact lenses.
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Efron N, Brennan NA, Chalmers RL, Jones L, Lau C, Morgan PB, Nichols JJ, Szczotka-Flynn LB, and Willcox MD
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- Humans, Refractive Errors metabolism, Refractive Errors physiopathology, Contact Lenses, Extended-Wear, Cornea metabolism, Refractive Errors therapy, Tears metabolism, Vision, Ocular physiology
- Abstract
Frequent replacement contact lenses made from the etafilcon A hydrogel lens material were introduced onto the market over 30 years ago, and etafilcon A remains the most widely used hydrogel lens material today. Although the prescribing of silicone hydrogel lenses is increasing, millions of lens wearers globally have been wearing hydrogel lenses for many years and exhibit a physiologically-stable 'quiet eye', with a low profile of adverse events. Hydrogel lenses are demonstrated to maintain a low inflammatory response and infection risk profile during daily wear, which in the case of etafilcon A, may be related to its low modulus, and the naturally-protective, anti-microbial, non-denatured lysozyme absorbed into the lens from the tear fluid. Although improved corneal physiology from decreased hypoxia with silicone hydrogel lenses is well accepted, equivalent levels of corneal oxygenation are maintained during daily wear of low to medium powered hydrogel lenses, which do not impede the daily corneal de-swelling process, and do not induce clinically significant changes in ocular health. Therefore, hydrogel lenses remain an important alternative for daily wear in modern contact lens practice., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2020
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10. Climatic and Environmental Correlates of Dry Eye Disease Severity: A Report From the Dry Eye Assessment and Management (DREAM) Study.
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Berg EJ, Ying GS, Maguire MG, Sheffield PE, Szczotka-Flynn LB, Asbell PA, and Shen JF
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- Conjunctiva, Cornea, Female, Humans, Male, Middle Aged, Severity of Illness Index, Tears, Dry Eye Syndromes diagnosis
- Abstract
Purpose: Correlate climate, weather parameters, and environmental exposures with the severity of symptoms and signs of dry eye disease (DED) in Dry Eye Assessment and Management (DREAM) study participants., Methods: Participants from five distinct climates completed the Ocular Surface Disease Index (OSDI) and were examined for corneal and conjunctival staining, tear breakup time (TBUT), and Schirmer's testing at baseline, 3, 6, and 12 months. Climate, weather parameters, and pollutants including ozone (O
3 ), carbon monoxide (CO), nitrous oxides (NO2 , NOx , NOy ), sulfur dioxide (SO2 ), particulate matter, and optical depth were obtained from governmental databases. Multivariate analysis and partial correlation coefficients (ρ) were used to assess associations, adjusted for age, sex, and the presence of Sjögren disease., Results: Among 535 participants, 81% were female and mean age was 58 years. Participants from the Mediterranean climate demonstrated better corneal fluorescein staining, better TBUT, and higher Schirmer's test scores throughout the calendar year (each P < 0.0001). Greater corneal fluorescein staining was associated with lower humidity ( P < 0.0038). TBUT measurements positively correlated with temperature, humidity, and dewpoint and inversely correlated with NO2 levels ( P < 0.0038). Paradoxically, some airborne pollutants were associated with less severe signs of dry eye ( P < 0.0038). Windspeed was not correlated with signs of DED, and OSDI scores did not correlate with individual environmental exposures., Conclusions: Dry eye signs differed between climates and local humidity levels. With the exception of NO2 , airborne pollutants were not associated with detrimental dry eye features., Translational Relevance: These results support limiting dry air exposure for patients with DED., Competing Interests: Disclosure: E.J. Berg, None; G.-S. Ying, Chengdu Kanghong Biotechnology Co. Ltd (C), Ziemer Ophthalmic Systems (C); M.G. Maguire, None; P.E. Sheffield, None; L.B. Szczotka-Flynn, Johnson & Johnson Vision Care (C, F), Alcon Laboratories (C, F); P.A. Asbell, Novaliq (C), Senju (C), Alcon (C), Kala (C), Allakon (C), Medscape (C), Sun Pharma (C), Dompe (C), Santen (C), Shire (C), CLAO (C), MC2 (F), Regeneron (C), Miotech (R); J.F. Shen, Ocugen (C), (Copyright 2020 The Authors.)- Published
- 2020
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11. Comparative corneal endothelial cell toxicity of differing intracameral moxifloxacin doses after phacoemulsification.
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Chang DF, Prajna NV, Szczotka-Flynn LB, Benetz BA, Lass JH, OʼBrien RC, Menegay HJ, Gardner S, Shekar M, Rajendrababu S, and Rhee DJ
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- Aged, Anterior Chamber drug effects, Anti-Bacterial Agents administration & dosage, Antibiotic Prophylaxis, Corneal Endothelial Cell Loss chemically induced, Corneal Endothelial Cell Loss diagnosis, Double-Blind Method, Female, Humans, Lens Implantation, Intraocular, Male, Middle Aged, Moxifloxacin administration & dosage, No-Observed-Adverse-Effect Level, Prospective Studies, Visual Acuity, Anti-Bacterial Agents toxicity, Endophthalmitis prevention & control, Endothelium, Corneal drug effects, Moxifloxacin toxicity, Phacoemulsification, Postoperative Complications prevention & control
- Abstract
Purpose: To determine whether intracameral moxifloxacin 500 μg is noninferior to 250 μg for central endothelial cell loss (ECL) after phacoemulsification., Setting: Aravind Eye Care System., Design: Prospective masked randomized study., Methods: Eyes with bilateral nuclear cataracts, central endothelial cell density (ECD) of more than 2000 cells/mm, and ECD not differing between eyes by more than 200 cells/mm underwent phacoemulsification at least 14 days apart. Intraoperatively, the first eye was randomized to receive either a 500 or 250 μg dose of moxifloxacin intracamerally and received the other dose for the second-eye surgery. Postoperative course was monitored at 1 day, 1 week, 1 month, and 3 months. Preoperative and 30-day and 90-day postoperative central ECD was determined by a reading center for a masked analysis of ECL at 3 months postoperatively., Results: Fifty eyes of 25 patients (aged 48 to 69 years) underwent uneventful surgery and had normal postoperative courses. The point estimate (PE) and 95% CI for the mean difference in % ECL between the 500 μg and 250 μg doses at 3 months postoperatively was 0.8% (-5.8%, 7.4%). Upon identifying and removing 2 outliers, noninferiority was proven with a mean difference of the PE, -2.2% (CI, -6.5%, 2.1%)., Conclusions: Clinical and corneal endothelial cell were comparable in this study population for the 250 μg and 500 μg doses of intracameral moxifloxacin. Both doses were well tolerated clinically, supporting the use of the higher dose for improved antimicrobial coverage for the prevention of postoperative endophthalmitis.
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- 2020
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12. Authors' Response.
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Szczotka-Flynn LB, Maguire MG, Ying GS, Lin MC, Bunya VY, Dana R, and Asbell PA
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- Algorithms, Humans, Visual Acuity, Contrast Sensitivity, Dry Eye Syndromes
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- 2019
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13. Prelamellar Dissection Donor Corneal Thickness Is Associated With Descemet Stripping Automated Endothelial Keratoplasty Operative Complications in the Cornea Preservation Time Study.
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Ross KW, Stoeger CG, Rosenwasser GOD, OʼBrien RC, Szczotka-Flynn LB, Ayala AR, Maguire MG, Benetz BA, Dahl P, Drury DC, Dunn SP, Farazdaghi SM, Hoover CK, Macsai MS, Mian SI, Nordlund ML, Penta JG, Soper MC, Terry MA, Verdier DD, Williams DV, and Lass JH
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- Adolescent, Adult, Aged, Child, Cornea pathology, Female, Humans, Intraoperative Complications etiology, Male, Middle Aged, Odds Ratio, Young Adult, Corneal Edema surgery, Descemet Stripping Endothelial Keratoplasty methods, Fuchs' Endothelial Dystrophy surgery
- Abstract
Purpose: To identify donor and recipient factors, including eye bank tissue observations, predictive of operative complications in the Cornea Preservation Time Study., Methods: One thousand three hundred thirty study eyes undergoing Descemet stripping automated endothelial keratoplasty for Fuchs dystrophy or pseudophakic/aphakic corneal edema were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (N = 675) or 8 to 14 days (N = 655). Donor factors included demographics, prelamellar corneal and postlamellar lenticule dissection thickness, central endothelial cell density, and tissue processing time. Recipient factors included demographics, intraocular pressure, and glaucoma medications or surgery (trabeculectomy, laser trabeculoplasty). Eye bank observations included donor tissue folds, pleomorphism/polymegethism, and endothelial cell abnormalities. Possible tissue-related operative complications were recorded including difficult donor lenticule unfolding and positioning. Multivariable logistic regression with backward selection was used to identify statistically significant (P < 0.01) associations between factors and operative complications., Results: The only factor predictive of operative complications [58 (4.4%) of 1330 surgeries] was prelamellar dissection donor corneal thickness (P = 0.002). For every 50 μm of donor corneal thickness prior to lamellar dissection, operative complication odds increased by 40% (odds ratio [99% confidence interval (CI)]: 1.40 [1.06-1.83]) adjusting for PT and whether the epithelium was on or off. The estimated mean prelamellar dissection donor corneal thickness for PT 0 to 7 days was 537 μm (99% CI: 516 μm-558 μm) compared with 567 μm (99% CI: 546 μm-588 μm) for PT 8 to 14 days (P < 0.001)., Conclusions: Thicker donor tissue (prelamellar dissection) is associated with operative complications and should be considered in tissue selection for Descemet stripping automated endothelial keratoplasty lenticule preparation.
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- 2019
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14. Postoperative Endothelial Cell Density Is Associated with Late Endothelial Graft Failure after Descemet Stripping Automated Endothelial Keratoplasty.
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Patel SV, Lass JH, Benetz BA, Szczotka-Flynn LB, Cohen NJ, Ayala AR, Maguire MG, Drury DC, Dunn SP, Jeng BH, Jones MF, Menegay HJ, Oliva MS, Rosenwasser GOD, Seedor JA, Terry MA, and Verdier DD
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- Adult, Aged, Aged, 80 and over, Cohort Studies, Corneal Endothelial Cell Loss etiology, Descemet Stripping Endothelial Keratoplasty methods, Endothelium, Corneal pathology, Female, Humans, Male, Middle Aged, Proportional Hazards Models, Corneal Edema surgery, Corneal Endothelial Cell Loss pathology, Descemet Stripping Endothelial Keratoplasty adverse effects, Fuchs' Endothelial Dystrophy surgery, Graft Rejection pathology, Pseudophakia surgery
- Abstract
Purpose: To determine whether preoperative endothelial cell density (ECD) and postoperative ECD after Descemet stripping automated endothelial keratoplasty (DSAEK) are associated with late endothelial graft failure (LEGF) in the Cornea Preservation Time Study (CPTS)., Design: Cohort study within a multicenter, randomized clinical trial., Participants: A total of 1007 individuals (1223 study eyes), mean age 70 years, undergoing DSAEK for Fuchs' dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (PACE) (6% of eyes) and followed for up to 5 years., Methods: Central ECD was determined by a central image analysis reading center. Preoperative ECD was determined for 1209 eyes that did not fail and 14 eyes that experienced LEGF. The ECD at 6 and 12 months after DSAEK, the change in ECD from preoperative to 6 and 12 months, surgeon-reported operative complications, and postoperative graft dislocation were investigated for an association with LEGFs unrelated to other postoperative events. Univariable and multivariable Cox proportional hazards regression models were used to assess associations., Main Outcome Measures: Late endothelial graft failure and its associations with pre- and postoperative ECD and operative complications., Results: The cumulative probability of LEGF was 1.3% (95% confidence interval [CI], 0.8%-2.4%). Median (interquartile range [IQR]) preoperative ECDs were similar for eyes with LEGF (2523; 2367-3161) cells/mm
2 ) and eyes without failure (2727; 2508-2973) cells/mm2 ) (P = 0.34). The ECD at 6 months was associated with LEGF (P < 0.001) in time-to-event analyses, whereas preoperative ECD was not (P = 0.55). The cumulative incidence (95% CI) of LEGF was 6.5% (3.0%, 14.0%) for 97 grafts with a 6-month ECD less than 1200 cells/mm2 , 0.3% (0.0%, 2.4%) for 310 grafts with a 6-month ECD between 1200 and 2000 cells/mm2 , and 0.6% (0.1%, 2.7%) for 589 grafts with a 6-month ECD greater than 2000 cells/mm2 . In multivariable analyses, ECD at 6 months and operative complications were both associated with LEGF (P = 0.002 and P = 0.01, respectively), whereas graft dislocation was not (P = 0.61)., Conclusions: In eyes undergoing DSAEK, preoperative ECD is unrelated to LEGF, whereas lower ECD at 6 months is associated with LEGF. Early endothelial cell loss after DSAEK and intraoperative complications should be minimized to improve graft survival., (Copyright © 2019 American Academy of Ophthalmology. All rights reserved.)- Published
- 2019
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15. Effect of Graft Attachment Status and Intraocular Pressure on Descemet Stripping Automated Endothelial Keratoplasty Outcomes in the Cornea Preservation Time Study.
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Aldave AJ, Terry MA, Szczotka-Flynn LB, Liang W, Ayala AR, Maguire MG, O'Brien RC, Benetz BA, Bokosky JE, Dunn SP, Gillette TE, Hammersmith KM, Hardten DR, Jeng BH, Jones MF, Lindstrom RL, Maverick KJ, Nirankari VS, Oliva MS, Raber IM, Rapuano CJ, Rosenwasser GOD, Ross KW, Seedor JW, Shamie N, Stoeger CG, Tauber S, Van Meter WS, Verdier DD, and Lass JH
- Subjects
- Adult, Aged, Aged, 80 and over, Cell Count, Corneal Edema diagnosis, Double-Blind Method, Female, Follow-Up Studies, Fuchs' Endothelial Dystrophy diagnosis, Graft Rejection diagnosis, Graft Survival, Humans, Male, Middle Aged, Prospective Studies, Risk Factors, Time Factors, Treatment Outcome, Cornea pathology, Corneal Edema surgery, Descemet Stripping Endothelial Keratoplasty methods, Fuchs' Endothelial Dystrophy surgery, Graft Rejection prevention & control, Intraocular Pressure physiology, Organ Preservation methods
- Abstract
Purpose: To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively., Design: Cohort study within a multi-center, double-masked, randomized clinical trial., Methods: 1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donor corneal tissue randomized by preservation time (PT) of 0-7 days (N = 675) or 8-14 days (N = 655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre- and post-operative IOP. Pre- and postoperative central donor ECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and (99% confidence intervals)., Results: Three independent predictive factors for GD were identified: a history of donor diabetes (odds ratio [OR]: 2.29 [1.30, 4.02]), increased pre-lamellar dissection central corneal thickness (OR: 1.13 [1.01, 1.27] per 25µ increase), and operative complications (OR: 2.97 [1.24, 7.11]). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD. 24 (2%) of 1330 study eyes had early acutely elevated postoperative IOP that was associated with a higher risk of graft failure through 3 years (hazard ratio: 3.42 [1.01, 11.53]), but not with a lower mean 3-year ECD (mean difference 61 (-479, 601) cells/mm
2 , P = .77). History of elevated postoperative IOP beyond 1 month was not significantly associated with 3-year graft success or ECD., Conclusions: Donor diabetes, increased donor corneal thickness, and intraoperative complications were associated with an increased risk of GD. Early acutely elevated postoperative IOP and GD significantly increased the risk for graft failure following DSAEK., (Copyright © 2019 Elsevier Inc. All rights reserved.)- Published
- 2019
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16. Impact of Dry Eye on Visual Acuity and Contrast Sensitivity: Dry Eye Assessment and Management Study.
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Szczotka-Flynn LB, Maguire MG, Ying GS, Lin MC, Bunya VY, Dana R, and Asbell PA
- Subjects
- Adult, Aged, Cross-Sectional Studies, Docosahexaenoic Acids therapeutic use, Double-Blind Method, Drug Combinations, Dry Eye Syndromes diagnosis, Dry Eye Syndromes drug therapy, Eicosapentaenoic Acid therapeutic use, Female, Humans, Male, Meibomian Glands physiopathology, Middle Aged, Tears physiology, Contrast Sensitivity physiology, Dry Eye Syndromes physiopathology, Visual Acuity physiology
- Abstract
Significance: Identification of the association of specific signs of dry eye disease with specific visual function deficits may allow for more targeted approaches to treatment., Purpose: The purpose of this study was to explore the association of dry eye signs and symptoms with visual acuity (VA) and contrast sensitivity in the Dry Eye Assessment and Management study., Methods: Baseline data from participants in the Dry Eye Assessment and Management study were used in this secondary cross-sectional analysis. Standardized procedures were used to obtain results on the Ocular Surface Disease Index (OSDI), high-contrast logMAR VA, contrast sensitivity, tear film debris, tear breakup time (TBUT), corneal fluorescein staining, meibomian gland evaluation, conjunctival lissamine green staining, and Schirmer test scores. Generalized linear models that included age, refractive error status, and cataract status were used to assess the association between VA and contrast sensitivity with OSDI score and each dry eye sign. The Hochberg procedure was used to account for multiple comparisons., Results: Among 487 participants (974 eyes), worse VA was associated with worse mean score on the OSDI vision subscale (39.4 for VA 20/32 or worse vs. 32.4 for VA 20/16 or better; adjusted linear trend, P = .02); scores were not associated with contrast sensitivity. Severe meibomian gland plugging and abnormal secretions were associated with worse mean log contrast sensitivity (1.48 for severe vs. 1.54 for not plugged [P = .04] and 1.49 for obstructed vs. 1.57 for clear [P = .002], respectively). Longer TBUT was associated with better mean log contrast sensitivity (1.57 for TBUT >5 seconds and 1.51 for TBUT ≤2 seconds, P < .0001)., Conclusions: Worse VA rather than worse contrast sensitivity drives vision-related symptoms in dry eye. Greater tear film instability was associated with worse contrast sensitivity.
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- 2019
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17. Comparison of Donor Cornea Endothelial Cell Density Determined by Eye Banks and by a Central Reading Center in the Cornea Preservation Time Study.
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Benetz BA, Stoeger CG, Patel SV, OʼBrien RC, Szczotka-Flynn LB, Ayala AR, Maguire MG, Menegay HJ, Bedard P, Clover JM, Gupta PC, McCoy KE, Song JC, and Lass JH
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- Adolescent, Adult, Aged, Child, Descemet Stripping Endothelial Keratoplasty, Endothelium, Corneal diagnostic imaging, Female, Humans, Male, Middle Aged, Young Adult, Cell Count methods, Corneal Endothelial Cell Loss diagnostic imaging, Endothelium, Corneal cytology, Eye Banks statistics & numerical data, Image Processing, Computer-Assisted statistics & numerical data
- Abstract
Purpose: To evaluate agreement between eye banks (EBs) and a reading center on endothelial cell density (ECD) determinations in the Cornea Preservation Time Study., Methods: The Cornea Image Analysis Reading Center (CIARC) performed variable frame image analysis on EB-obtained-preoperative central endothelial images (after lamellar dissection for Descemet stripping automated endothelial keratoplasty by the EBs or before shipping, if surgeon prepared) to determine ECD. The EBs performed their usual method of ECD determination. The CIARC and EBs also provided ECD determinations from screening central endothelial images taken by the EBs during donor evaluation. Two independent masked CIARC readers determined ECD with measurements averaged., Results: The mean preoperative ECD was 15 cells/mm greater by the EBs than by CIARC (N = 1286, P < 0.001) with 95% limits of agreement of (-644, 675 cells/mm). The limits of agreement in preoperative ECD were wider in the After-Lamellar-Dissection Group (-687, 683 cells/mm) than in the Before Shipping Group [(-505, 633 cells/mm); P = 0.03]. The EBs-determined preoperative ECD was within 10% of the CIARC-determined ECD for 886 (69%) image sets, with 236 (18%) higher by >10% and 164 (13%) lower by >10%. Excellent agreement appeared between the EBs and CIARC when 100-300 cells could be analyzed in contrast to <100 cells (SD = 308 cells/mm vs. SD = 603 cells/mm; P < 0.001)., Conclusions: The mean ECD by the EBs and CIARC were similar, but there was considerable variability between determinations for individual corneas. Agreement improved between the 2 measurements when more than 100 cells were able to be analyzed.
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- 2019
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18. Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study.
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Lass JH, Benetz BA, Patel SV, Szczotka-Flynn LB, O'Brien R, Ayala AR, Maguire MG, Daoud YJ, Greiner MA, Hannush SB, Lee WB, Mauger TF, Menegay HJ, Mifflin MD, Raizman MB, Rose-Nussbaumer J, Schultze RL, Schmidt GA, Sugar A, Terry MA, and Verdier DD
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Cell Count, Child, Corneal Edema surgery, Double-Blind Method, Endothelium, Corneal pathology, Female, Fuchs' Endothelial Dystrophy surgery, Graft Survival physiology, Humans, Male, Middle Aged, Prospective Studies, Risk Factors, Time and Motion Studies, Cornea, Corneal Endothelial Cell Loss diagnosis, Descemet Stripping Endothelial Keratoplasty, Organ Preservation methods, Tissue Donors, Transplant Recipients
- Abstract
Importance: Determining factors associated with endothelial cell loss after Descemet stripping automated endothelial keratoplasty (DSAEK) could improve long-term graft survival., Objective: To evaluate the associations of donor, recipient, and operative factors with endothelial cell density (ECD) 3 years after DSAEK in the Cornea Preservation Time Study., Design, Setting, and Participants: This cohort study was a secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. Individuals undergoing DSAEK for Fuchs dystrophy or pseudophakic/aphakic corneal edema were included., Interventions: The DSAEK procedure, with random assignment of a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days., Main Outcomes and Measures: Endothelial cell density at 3 years as determined by a reading center from eye bank and clinical specular or confocal central endothelial images., Results: The study included 1090 participants (median age, 70 years) with 1330 affected eyes (240 bilateral cases [22.0%]), who underwent DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic/aphakic corneal edema (PACE) (75 eyes [5.6%]). Of these, 801 eyes (60.2%) belonged to women and 1207 (90.8%) to white individuals. A total of 749 participants (913 eyes; 164 [21.9%] bilateral cases) had functioning grafts with acceptable endothelial images preoperatively and at 3 years postoperatively and were included in this analysis. Factors associated with a lower ECD at 3 years (estimated effect with 99% CI) in the final multivariable model included donors with diabetes (-103 [-196 to -9] cells/mm2), lower screening ECD (-234 [-331 to -137] per 500 cells/mm2), recipient diagnosis of PACE (-257 [-483 to -31] in cells/mm2), and operative complications (-324 [-516 to -133] in cells/mm2). Endothelial cell loss (ECL) from a preoperative measurement to a 3-year postoperative measurement was 47% (99% CI, 42%-52%) for participants receiving tissue from donors with diabetes vs 43% (99% CI, 39%-48%) without diabetes; it was 53% (99% CI, 44%-62%) for participants diagnosed with PACE vs 44% (99% CI, 39%-49%) for those diagnosed with Fuchs dystrophy, and 55% (99% CI, 48%-63%) in participants who experienced operative complications vs 44% (99% CI, 39%-48%) in those who did not. No other donor, recipient, or operative factors were significantly associated with 3-year ECD., Conclusions and Relevance: Donor diabetes, lower screening ECD, a PACE diagnosis in the recipient, and operative complications were associated with lower ECD at 3 years after DSAEK surgery and may be associated with long-term graft success. While causation cannot be inferred, further studies on the association of donor diabetes and PACE in recipients with lower 3-year ECD warrant further study.
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- 2019
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19. Factors Associated With Graft Rejection in the Cornea Preservation Time Study.
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Stulting RD, Lass JH, Terry MA, Benetz BA, Cohen NJ, Ayala AR, Maguire MG, Croasdale C, Daoud YJ, Dunn SP, Goins KM, Gupta PC, Macsai MS, Mian SI, Pramanik S, Rose-Nussbaumer J, Song JC, Stark WJ, Sugar A, Verdier DD, and Szczotka-Flynn LB
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- Age Factors, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Risk Factors, Time Factors, Corneal Diseases surgery, Descemet Stripping Endothelial Keratoplasty methods, Graft Rejection, Organ Preservation methods
- Abstract
Purpose: To identify factors related to graft rejection following Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS)., Design: Cohort study within a multicenter randomized clinical trial., Methods: A total of 1330 eyes of 1090 subjects undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0-7 days (n = 675) or 8-14 days (n = 655) and followed for 3 years. Central endothelial cell density (ECD) was determined by a central image analysis reading center. Multivariable Cox models adjusted for PT, recipient diagnosis, and surgeon effect were used to identify factors associated with rejection., Results: Cumulative probability of definite graft rejection was 3.6% (99% confidence interval 2.5%-5.3%). Younger recipient age was associated with graft rejection (P < .001; hazard ratio: 0.53 [0.33, 0.83] per decade). PT, donor-recipient sex mismatch, recipient diagnosis, recipient race, graft size, discontinuation of topical corticosteroids and immune-modulators, prior immunizations within 3 months, and prior glaucoma surgery were not associated with rejection (P > .01). Among clear grafts with an ECD measurement at baseline and 3 years (n = 913), endothelial cell loss (ECL) was greater in eyes that experienced a rejection episode (n = 27) than in those that did not (n = 886) (48% vs 38%, P = .03). Twelve of 44 eyes (27%) with definite graft rejection subsequently failed, comprising 15% of the 79 failures in the CPTS., Conclusions: Graft rejection is uncommon after DSAEK and more likely with younger age, in a study cohort mostly > 50 years old. Rejection increases ECL, but it is not a leading cause of DSAEK failure., (Copyright © 2018 Elsevier Inc. All rights reserved.)
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- 2018
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20. Donor, Recipient, and Operative Factors Associated with Graft Success in the Cornea Preservation Time Study.
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Terry MA, Aldave AJ, Szczotka-Flynn LB, Liang W, Ayala AR, Maguire MG, Croasdale C, Daoud YJ, Dunn SP, Hoover CK, Macsai MS, Mauger TF, Pramanik S, Rosenwasser GOD, Rose-Nussbaumer J, Stulting RD, Sugar A, Tu EY, Verdier DD, Yoo SH, and Lass JH
- Subjects
- Adult, Aged, Cell Count, Cohort Studies, Corneal Edema physiopathology, Double-Blind Method, Endothelium, Corneal cytology, Eye Banks, Female, Fuchs' Endothelial Dystrophy physiopathology, Humans, Male, Middle Aged, Postoperative Period, Time Factors, Time and Motion Studies, Visual Acuity physiology, Corneal Edema surgery, Descemet Stripping Endothelial Keratoplasty methods, Fuchs' Endothelial Dystrophy surgery, Graft Survival physiology, Organ Preservation, Tissue Donors, Transplant Recipients
- Abstract
Purpose: To associate donor, recipient, and operative factors with graft success 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS)., Design: Cohort study within a multicenter, double-masked, randomized clinical trial., Participants: One thousand ninety individuals (1330 study eyes) with a median age of 70 years undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (PACE; 6% of eyes)., Methods: Eyes undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (n = 675) or 8 to 14 days (n = 655). Donor, recipient, and operative parameters were recorded prospectively. Graft failure was defined as regraft for any reason, a graft that failed to clear by 8 weeks after surgery, or an initially clear graft that became and remained cloudy for 90 days. Failure in the first 8 weeks was classified further as primary donor failure or early failure, in the absence or presence of operative complications, respectively. Proportional hazards and logistic regression models were used to estimate risk ratios (RR) and 99% confidence intervals (CIs) for graft failure., Main Outcome Measures: Graft success at 3 years., Results: One thousand two hundred fifty-one of 1330 grafts (94%) remained clear at 3 years and were considered successful. After adjusting for PT, tissue from donors with diabetes (RR, 2.35; 99% CI, 1.03-5.33) and operative complications (RR, 4.21; 99% CI, 1.42-12.47) were associated with increased risk for primary or early failure. Preoperative diagnosis of PACE (RR, 3.59; 99% CI, 1.05-12.24) was associated with increased risk for late failure by 3 years after surgery compared with Fuchs dystrophy. Graft success showed little variation among other factors evaluated, including donor age (RR, 1.19 per decade; 99% CI, 0.91-1.56 per decade), preoperative donor endothelial cell density (RR, 1.10 per 500 cells; 99% CI, 0.74-1.63 per 500 cells), graft diameter (RR, 1.22 per 1 mm; 99% CI, 0.39-3.76 per 1 mm), and injector use for graft insertion (RR, 0.92; 99% CI, 0.40-2.10)., Conclusions: Descemet stripping automated endothelial keratoplasty success in the early and entire postoperative period is more likely when the donor did not have diabetes and was without operative complications and in the long-term postoperative period in recipients with Fuchs dystrophy compared with those with PACE. Mechanisms whereby diabetic donors and PACE recipients reduce the rate of graft success after DSAEK warrant further study., (Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
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- 2018
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21. Incidence and Outcomes of Positive Donor Rim Cultures and Infections in the Cornea Preservation Time Study.
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Mian SI, Aldave AJ, Tu EY, Ayres BD, Jeng BH, Macsai MS, Nordlund ML, Penta JG, Pramanik S, Szczotka-Flynn LB, Ayala AR, Liang W, Maguire MG, and Lass JH
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- Adult, Aged, Aged, 80 and over, Bacteria isolation & purification, Corneal Diseases surgery, Corneal Ulcer microbiology, Endophthalmitis microbiology, Eye Banks, Eye Infections, Bacterial microbiology, Eye Infections, Fungal microbiology, Female, Fungi isolation & purification, Humans, Incidence, Male, Middle Aged, Prospective Studies, Time Factors, Transplant Recipients, Treatment Outcome, Cornea microbiology, Corneal Ulcer epidemiology, Endophthalmitis epidemiology, Eye Infections, Bacterial epidemiology, Eye Infections, Fungal epidemiology, Organ Preservation methods, Tissue Donors
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Purpose: To assess donor rim culture results and outcomes of ocular infections in the Cornea Preservation Time Study (CPTS)., Methods: Donor corneal rim cultures were optional. Donor characteristics were assessed for association with positive cultures using the Fisher exact test and Poisson regression analyses. Incidence rates of ocular infections were estimated, and 95% confidence intervals were calculated., Results: Cultures were performed in 784 (58.9%) of the 1330 cases. For the 0 to 7-day versus 8 to 14-day preservation time groups, respectively, positive fungal growth occurred in 10 of 397 (2.5%) versus 5 of 387 (1.3%) corneas (P = 0.30), whereas positive bacterial cultures occurred in 6 of 397 (1.5%) versus 4 of 387 (1.0%) corneas (P = 0.75). Surgeon-prepared tissue remained a significant risk for positive fungal cultures [relative risk (RR) of surgeon- versus eye-bank-prepared, 2.85; 95% CI (1.02-7.98)], whereas younger donors [RR per year of age, 0.96; 95% CI (0.93-1.00)] and accidental death donors [RR of accident versus disease, 3.71; 95% CI (1.36-10.13)] were at a greater risk for positive bacterial cultures. Fungal infection (Candida glabrata) developed in 1 (6.7%) of 15 recipients with a positive fungal culture, and no recipient infections occurred with positive bacterial culture. With one additional fungal keratitis (Candida albicans) and one bacterial endophthalmitis (E. coli) with no rim culture performed, a total of 2 of 1330 eyes (0.15%) developed fungal and 1/1330 eyes (0.08%) developed bacterial postkeratoplasty infections., Conclusions: A longer preservation time was not associated with a higher rate of positive donor rim cultures. The overall rate of infection across the entire cohort was low.
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- 2018
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22. n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease.
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Asbell PA, Maguire MG, Pistilli M, Ying GS, Szczotka-Flynn LB, Hardten DR, Lin MC, and Shtein RM
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- Administration, Oral, Adult, Aged, Docosahexaenoic Acids adverse effects, Double-Blind Method, Eicosapentaenoic Acid adverse effects, Female, Humans, Male, Middle Aged, Olive Oil adverse effects, Olive Oil therapeutic use, Severity of Illness Index, Treatment Failure, Dietary Supplements adverse effects, Docosahexaenoic Acids therapeutic use, Eicosapentaenoic Acid therapeutic use, Keratoconjunctivitis Sicca drug therapy
- Abstract
Background: Dry eye disease is a common chronic condition that is characterized by ocular discomfort and visual disturbances that decrease quality of life. Many clinicians recommend the use of supplements of n-3 fatty acids (often called omega-3 fatty acids) to relieve symptoms., Methods: In a multicenter, double-blind clinical trial, we randomly assigned patients with moderate-to-severe dry eye disease to receive a daily oral dose of 3000 mg of fish-derived n-3 eicosapentaenoic and docosahexaenoic acids (active supplement group) or an olive oil placebo (placebo group). The primary outcome was the mean change from baseline in the score on the Ocular Surface Disease Index (OSDI; scores range from 0 to 100, with higher scores indicating greater symptom severity), which was based on the mean of scores obtained at 6 and 12 months. Secondary outcomes included mean changes per eye in the conjunctival staining score (ranging from 0 to 6) and the corneal staining score (ranging from 0 to 15), with higher scores indicating more severe damage to the ocular surface, as well as mean changes in the tear break-up time (seconds between a blink and gaps in the tear film) and the result on Schirmer's test (length of wetting of paper strips placed on the lower eyelid), with lower values indicating more severe signs., Results: A total of 349 patients were assigned to the active supplement group and 186 to the placebo group; the primary analysis included 329 and 170 patients, respectively. The mean change in the OSDI score was not significantly different between the active supplement group and the placebo group (-13.9 points and -12.5 points, respectively; mean difference in change after imputation of missing data, -1.9 points; 95% confidence interval [CI], -5.0 to 1.1; P=0.21). This result was consistent across prespecified subgroups. There were no significant differences between the active supplement group and the placebo group in mean changes from baseline in the conjunctival staining score (mean difference in change, 0.0 points; 95% CI, -0.2 to 0.1), corneal staining score (0.1 point; 95% CI, -0.2 to 0.4), tear break-up time (0.2 seconds; 95% CI, -0.1 to 0.5), and result on Schirmer's test (0.0 mm; 95% CI, -0.8 to 0.9). At 12 months, the rate of adherence to treatment in the active supplement group was 85.2%, according to the level of n-3 fatty acids in red cells. Rates of adverse events were similar in the two trial groups., Conclusions: Among patients with dry eye disease, those who were randomly assigned to receive supplements containing 3000 mg of n-3 fatty acids for 12 months did not have significantly better outcomes than those who were assigned to receive placebo. (Funded by the National Eye Institute, National Institutes of Health; DREAM ClinicalTrials.gov number, NCT02128763 .).
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- 2018
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23. Daily Wear Contact Lenses Manufactured in Etafilcon A Are Noninferior to Two Silicone Hydrogel Lens Types With Respect to Hypoxic Stress.
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Szczotka-Flynn LB, Debanne S, Benetz BA, Wilson T, and Brennan N
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- Adult, Blister pathology, Corneal Edema physiopathology, Cross-Over Studies, Endothelium, Corneal pathology, Female, Humans, Hydrogel, Polyethylene Glycol Dimethacrylate, Hydrogels, Limbus Corneae pathology, Male, Methacrylates, Middle Aged, Prospective Studies, Silicones, Stress, Physiological physiology, Young Adult, Contact Lenses, Hydrophilic adverse effects, Cornea physiopathology, Corneal Edema etiology, Hypoxia etiology
- Abstract
Purpose: This study hypothesized that a traditional high-water contact lens of moderate oxygen transmissibility (Dk/t) is noninferior to common silicone hydrogel (SH) lenses worn for daily wear with respect to measures of hypoxic stress., Methods: Thirty-six habitual contact lens wearers completed wear of three lens types worn in a randomized order: etafilcon A (ACUVUE 2, control), lotrafilcon B (Air Optix Aqua), and comfilcon A (Biofinity). Central corneal thickness (CT) and limbal hyperemia were measured >2 hr after waking and after 6 to 8 hr of wear on days 1 and 7. Endothelial bleb formation was measured on day 1 of each lens type. Noninferiority of etafilcon A, with respect to the other two lens types, was assumed if the following difference margins of equivalence were met: <1.5% for corneal swelling, <0.5 grade for limbal hyperemia, and <1% area of endothelial blebs. Outcomes were modeled using generalized linear mixed modeling techniques., Results: All lenses showed reductions in least-square mean estimates of CT on both days: etafilcon A -0.26% at day 1 and -0.31% at day 7; lotrafilcon B -1.11% at day 1 and -1.06% at day 7; comfilcon A -0.63% at day 1 and -0.84% at day 7. The difference in mean swelling between etafilcon A and lotrafilcon B was 0.85% at day 1 (95% confidence interval [0.4%-1.3%]) and 0.75% at day 7 (0.3%-1.2%). The difference in mean swelling between etafilcon A and comfilcon A was 0.37% at day 1 (-0.1% to 0.8%) and 0.53% at day 7 (0.1%-1.0%). For limbal redness, etafilcon A fell within 0.1 grade of lotrafilcon B and 0.18 grade of comfilcon A. For endothelial bleb formation, etafilcon A fell within 0.45% of lotrafilcon B and 0.23% of comfilcon A., Conclusion: The etafilcon A control lens resulted in corneal deswelling throughout the day as did the SH lens types. Limbal hyperemia and endothelial bleb formation with all lenses were negligible, and noninferiority assumptions were met between the lens types for all outcomes. Equivalence of etafilcon A with respect to the two SH lenses for three measures of hypoxic stress was demonstrated.
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- 2018
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24. Corneal Endothelial Cell Loss 3 Years After Successful Descemet Stripping Automated Endothelial Keratoplasty in the Cornea Preservation Time Study: A Randomized Clinical Trial.
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Lass JH, Benetz BA, Verdier DD, Szczotka-Flynn LB, Ayala AR, Liang W, Aldave AJ, Dunn SP, McCall T, Mian SI, Navarro LC, Patel SV, Pramanik S, Rosenwasser GO, Ross KW, Terry MA, Kollman C, Gal RL, and Beck RW
- Subjects
- Adult, Aged, Aged, 80 and over, Cell Count, Double-Blind Method, Endothelium, Corneal pathology, Female, Fuchs' Endothelial Dystrophy surgery, Graft Survival, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Tissue Donors, Cornea, Corneal Endothelial Cell Loss etiology, Cryopreservation, Descemet Stripping Endothelial Keratoplasty adverse effects, Organ Preservation, Postoperative Complications
- Abstract
Importance: Demonstrating that endothelial cell loss following Descemet stripping automated endothelial keratoplasty (DSAEK) is independent of donor cornea preservation time (PT) could increase the pool of corneal tissue available for keratoplasty., Objective: To determine whether endothelial cell loss 3 years after successful DSAEK is related to PT., Design, Setting, and Participants: A multicenter, double-masked, randomized clinical trial included 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 945 eyes of 769 participants were included in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEK, performed primarily for Fuchs endothelial corneal dystrophy (96% of the cohort). The study was conducted from April 16, 2012, to June 5, 2017., Interventions: DSAEK with random assignment of a donor cornea with PT of 0 to 7 days (0-7d PT) or 8 to 14 days (8-14d PT)., Main Outcomes and Measures: Endothelial cell density (ECD) at 3 years determined by a central image analysis reading center from clinical specular or confocal central endothelial images., Results: Nine hundred forty-five eyes of 769 participants (median age, 70 years [range, 42-90 years], 60.8% women, 93.0% white) in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEK were included. At the initial eye bank tissue screening, mean (SD) central ECD was 2746 (297) cells/mm2 in the 0-7d PT group (n = 485) and 2723 (284) cells/mm2 in the 8-14d PT group (n = 460). At 3 years, the mean (SD) ECD decreased from baseline by 37% (21%) in the 0-7d PT group and 40% (22%) in the 8-14d PT group to 1722 (626) cells/mm2 and 1642 (631) cells/mm2, respectively (mean difference, 73 cells/mm2; 95% CI, 8-138 cells/mm2; P = .03). When analyzed as a continuous variable (days), longer PT was associated with lower ECD (mean difference by days, 15 cells/mm2; 95% CI, 4-26 cells/mm2; P = .006). Endothelial cell loss (ECL) was comparable from 4 to 13 days’ PT (n = 878; 36%-43% when tabulated by day). Available extension study ECD results at 4 years mirrored those at 3 years in the 203 eyes in the 0-7d PT group (mean [SD] ECD, 1620 [673] cells/mm2 and mean [SD] ECL, 41% [23%]) and 209 eyes in the 8-14d PT group (mean [SD] ECD, 1537 [683] cells/mm2 and mean [SD] ECL, 44% [23%]) (mean difference, 112 cells/mm2; 95% CI, 5-219 cells/mm2; P = .04)., Conclusions and Relevance: Although ECL 3 years after Descemet stripping automated endothelial keratoplasty is greater with longer PT, the effect of PT on ECL is comparable from 4 to 13 days’ PT.
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- 2017
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25. Effect of Cornea Preservation Time on Success of Descemet Stripping Automated Endothelial Keratoplasty: A Randomized Clinical Trial.
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Rosenwasser GO, Szczotka-Flynn LB, Ayala AR, Liang W, Aldave AJ, Dunn SP, McCall T, Navarro LC, Pramanik S, Ross KW, Stulting RD, Terry MA, Tu EY, Verdier DD, Kollman C, Gal RL, Beck RW, and Lass JH
- Subjects
- Adult, Aged, Aged, 80 and over, Cell Count, Corneal Endothelial Cell Loss physiopathology, Double-Blind Method, Endothelium, Corneal pathology, Eye Banks, Female, Fuchs' Endothelial Dystrophy physiopathology, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Tissue Donors, Cornea, Cryopreservation methods, Descemet Stripping Endothelial Keratoplasty methods, Fuchs' Endothelial Dystrophy surgery, Graft Survival physiology, Organ Preservation methods
- Abstract
Importance: Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool., Objective: To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less., Design, Setting, and Participants: A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 1090 individuals (1330 study eyes) underwent Descemet stripping automated endothelial keratoplasty (1255 eyes [94.4%] for Fuchs endothelial corneal dystrophy)., Interventions: Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with a PT of 7 days or less (0-7d PT) or 8 to 14 days (8-14d PT)., Main Outcomes and Measures: Graft success at 3 years., Results: Of the 1090 participants (1330 study eyes; 60.2% women and 39.8% men; median age at enrollment, 70 years [range, 42-90 years]), the 3-year cumulative probability of graft success was 95.3% (95% CI, 93.6%-96.9%) in the 0-7d PT group and 92.1% (95% CI, 89.9%-94.2%) in the 8-14d PT group (difference, 3.2%). The upper limit of the 1-sided 95% CI on the difference was 5.4%, exceeding the prespecified noninferiority limit of 4%. The difference was mostly owing to more primary donor failures in the 8-14d PT group, with the conditional probability of failure after the first month being 2.4% in the 0-7d PT group and 3.1% in the 8-14d PT group. In preplanned secondary analyses, longer PT was associated with a lower rate of graft success (unadjusted hazard ratio for graft failure per additional day of PT, 1.10; 95% CI, 1.03-1.18; P = .008 [PT analyzed as days]), with success rates of 96.5% (95% CI, 92.3%-98.4%) for PT of 4 days or less, 94.9% (95% CI, 92.5%-96.6%) for PT of 5 to 7 days, 93.8% (95% CI, 91.0%-95.8%) for PT of 8 to 11 days, and 89.3% (95% CI, 84.4%-92.7%) for PT of 12 to 14 days (P = .01 [PT analyzed as categorical variable])., Conclusions and Relevance: The 3-year success rate in eyes undergoing Descemet stripping automated endothelial keratoplasty was high irrespective of PT. However, the study was unable to conclude that the success rate with donor corneas preserved 8 to 14 days was similar to that of corneas preserved 7 days or less with respect to the prespecified noninferiority limit. Although longer PT was associated with a lower success rate, the difference in rates was small when PT was less than 12 days.
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- 2017
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26. Validity of Postmortem Glycated Hemoglobin to Determine Status of Diabetes Mellitus in Corneal Donors.
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Soper MC, Marcovina SM, Hoover CK, Calhoun PM, McCoy KE, Stoeger CG, Schmidt GA, Arafah BM, Price MO, Szczotka-Flynn LB, and Lass JH
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- Blood Glucose analysis, Chromatography, High Pressure Liquid, Corneal Diseases blood, Corneal Diseases mortality, Diabetes Mellitus blood, Diabetes Mellitus mortality, Eye Banks methods, Female, Humans, Male, Reproducibility of Results, Cornea, Corneal Diseases diagnosis, Diabetes Mellitus diagnosis, Diagnosis, Glycated Hemoglobin analysis, Tissue Donors
- Abstract
Purpose: To examine the stability of postmortem glycated hemoglobin (HbA1c) measurement and its relationship to premortem glycemia., Methods: Postmortem blood samples were obtained from 32 donors (8 known diabetic) and shipped on ice to a central laboratory to examine the stability of HbA1c measurements during the first 9 postmortem days. Thirty-nine other suspected diabetic donors underwent comparison of premortem and postmortem HbA1c measurements., Results: Postmortem HbA1c measurements remained stable after 9 postmortem days (all measurements within ±0.2% from baseline with a mean difference of 0.02% ± 0.10%). Of the premortem measurements obtained within 90 days before death, 79% were within ±1.0% of the postmortem measurements compared with 40% for measurements more than 90 days apart. Three of the postmortem HbA1c measurements exceeded 6.5% (considered a threshold for diabetes diagnosis), although the medical histories did not indicate any previous diabetes diagnosis., Conclusions: Postmortem HbA1c testing is feasible with current eye bank procedures and is reflective of glycemic control of donors during 90 days before death. HbA1c testing could potentially be a useful adjunct to review of the medical history and records for donor assessment for endothelial keratoplasty suitability and long-term graft success.
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- 2017
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27. Mucin Balls Influence Corneal Infiltrative Events.
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Szczotka-Flynn LB, Jiang Y, Stiegemeier MJ, Mutti DO, Walline J, Wilson T, and Debanne S
- Subjects
- Adult, Colony Count, Microbial, Corneal Ulcer diagnosis, Corneal Ulcer microbiology, Eye Infections, Bacterial diagnosis, Eye Infections, Bacterial microbiology, Female, Follow-Up Studies, Humans, Male, Proportional Hazards Models, Risk Factors, Bacteria isolation & purification, Contact Lenses, Extended-Wear microbiology, Corneal Ulcer prevention & control, Eye Infections, Bacterial prevention & control, Hydrogels, Mucins physiology, Silicones
- Abstract
Purpose: To determine whether mucin ball (MB) formation is protective against corneal infiltrative events (CIEs) as previously reported., Methods: Two hundred eighty-two eligible participants were enrolled at three sites in the USA. Participants began a 1-month continuous wear run-in period with high modulus lotrafilcon A lenses to assess their ability to form MBs (phase 1). Subsequently, they were stratified by this characteristic and randomized to balafilcon A or comfilcon A lenses for 7-day extended wear and followed for 1 year (phase 2). MB formation in each phase was defined as repeated presence of any MBs on a person level. Multivariable Cox proportional hazards regression was used to model the probability of a CIE as a function of MB formation in each phase and other covariates., Results: Of the 282 participants who entered phase 1, 218 of them entered the phase 2 randomized trial during which 33 CIEs occurred. Overall, 74%, 61%, and 79% of participants repeatedly produced MBs in lotrafilcon A, balafilcon A, and comfilcon A lenses, respectively. Early repeated MB presence in phase 1 with lotrafilcon A lenses significantly increased the rate of CIEs in phase 2 (12-month follow-up) by 466% (HR 4.66, 95% confidence interval 1.10-19.79, P = .0372). Repeated, longer-term MB presence during wear of balafilcon A or comfilcon A in phase 2 did not significantly reduce the incidence of CIEs; however, it significantly decreased the rate of CIEs by 62% (hazard ratio (HR) 0.380, 95% confidence interval 0.145-0.998, P = .0494)., Conclusions: The overarching hypothesis that MB formation is protective against CIEs throughout extended wear was not supported. Although a protective effect of longer-term MB presence on rate of CIEs was detected, early-onset MB formation substantially increased the hazard for CIE in subsequent wear with different lens types.
- Published
- 2017
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28. Cornea preservation time study: methods and potential impact on the cornea donor pool in the United States.
- Author
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Lass JH, Szczotka-Flynn LB, Ayala AR, Benetz BA, Gal RL, Aldave AJ, Corrigan MM, Dunn SP, McCall TL, Pramanik S, Rosenwasser GO, Ross KW, Terry MA, and Verdier DD
- Subjects
- Adolescent, Adult, Aged, Cell Count, Child, Corneal Edema physiopathology, Corneal Edema surgery, Corneal Pachymetry, Eye Banks statistics & numerical data, Female, Fuchs' Endothelial Dystrophy physiopathology, Fuchs' Endothelial Dystrophy surgery, Humans, Intraocular Pressure physiology, Male, Middle Aged, Time Factors, Transplant Recipients, United States, Cryopreservation methods, Descemet Membrane, Descemet Stripping Endothelial Keratoplasty statistics & numerical data, Endothelium, Corneal, Graft Survival physiology, Organ Preservation methods, Tissue Donors statistics & numerical data
- Abstract
Purpose: The aim of this study was to describe the aims, methods, donor and recipient cohort characteristics, and potential impact of the Cornea Preservation Time Study (CPTS)., Methods: The CPTS is a randomized clinical trial conducted at 40 clinical sites (70 surgeons) designed to assess the effect of donor cornea preservation time (PT) on graft survival 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK). Eyes undergoing surgery for Fuchs endothelial corneal dystrophy or pseudophakic/aphakic corneal edema were randomized to receive donor corneas stored ≤7 days or 8 to 14 days. Donor and patient characteristics, tissue preparation and surgical parameters, recipient and donor corneal stroma clarity, central corneal thickness, intraocular pressure, complications, and a reading center-determined central endothelial cell density were collected. Surveys were conducted to evaluate pre-CPTS PT practices., Results: The 1330 CPTS donors were: 49% >60 years old, 27% diabetic, had a median eye bank-determined screening endothelial cell density of 2688 cells/mm, and 74% eye bank prepared for DSAEK. A total of 1090 recipients (1330 eyes including 240 bilateral cases) had: median age of 70 years, were 60% female, 90% white, 18% diabetic, 52% phakic, and 94% had Fuchs endothelial corneal dystrophy. Before the CPTS, 19 eye banks provided PT data on 20,852 corneas domestically placed for DSAEK in 2010 to 2011; 96% were preserved ≤7 days. Of 305 American Academy of Ophthalmology members responding to a pre-CPTS survey, 233 (76%) set their maximum PT preference at 8 days or less., Conclusions: The CPTS will increase understanding of factors related to DSAEK success and, if noninferiority of longer PT is shown, will have great potential to extend the available pool of endothelial keratoplasty donors.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01537393.
- Published
- 2015
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29. Risk factors for contact lens-induced papillary conjunctivitis associated with silicone hydrogel contact lens wear.
- Author
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Tagliaferri A, Love TE, and Szczotka-Flynn LB
- Subjects
- Adolescent, Adult, Female, Humans, Male, Middle Aged, Proportional Hazards Models, Retrospective Studies, Risk Factors, Young Adult, Conjunctivitis, Allergic etiology, Contact Lenses, Extended-Wear adverse effects, Hydrogels adverse effects, Silicone Elastomers adverse effects
- Abstract
Background: Contact lens-induced papillary conjunctivitis (CLPC) continues to be a major cause of dropout during extended wear of contact lenses. This retrospective study explores risk factors for the development of CLPC during extended wear of silicone hydrogel lenses., Methods: Data from 205 subjects enrolled in the Longitudinal Analysis of Silicone Hydrogel Contact Lens study wearing lotrafilcon A silicone hydrogel lenses for up to 30 days of continuous wear were used to determine risk factors for CLPC in this secondary analysis of the main cohort. The main covariates of interest included substantial lens-associated bacterial bioburden and topographically determined lens base curve-to-cornea fitting relationships. Additional covariates of interest included history of adverse events, time of year, race, education level, gender, and other subject demographics. Statistical analyses included univariate logistic regression to assess the impact of potential risk factors on the binary CLPC outcome and Cox proportional hazards regression to describe the impact of those factors on time-to-CLPC diagnosis., Results: Across 12 months of follow-up, 52 subjects (25%) experienced CLPC. No associations were found between the CLPC development and the presence of bacterial bioburden, lens-to-cornea fitting relationships, history of adverse events, gender, or race. Contact lens-induced papillary conjunctivitis development followed the same seasonal trends as the local peaks in environmental allergens., Conclusions: Lens fit and biodeposits, in the form of lens-associated bacterial bioburden, were not associated with the development of CLPC during extended wear with lotrafilcon A silicone hydrogel lenses.
- Published
- 2014
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30. Risk factors for microbial bioburden during daily wear of silicone hydrogel contact lenses.
- Author
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Jiang Y, Jacobs M, Bajaksouzian S, Foster AN, Debanne SM, Bielefeld R, Garvey M, Raghupathy S, Kern J, and Szczotka-Flynn LB
- Subjects
- Adolescent, Adult, Aged, Anti-Infective Agents pharmacology, Conjunctiva microbiology, Contact Lens Solutions pharmacology, Equipment Contamination statistics & numerical data, Eye Infections, Bacterial prevention & control, Eyelids microbiology, Female, Humans, Hydrogen Peroxide pharmacology, Logistic Models, Male, Middle Aged, Occupations statistics & numerical data, Risk Factors, Smoking adverse effects, Young Adult, Contact Lenses, Hydrophilic microbiology, Hydrogels, Silicone Gels
- Abstract
Purpose: To assess risk factors associated with substantial microbial bioburden of lids, conjunctivae, contact lenses, and storage cases during daily wear of silicone hydrogel contact lenses., Methods: Two hundred eighteen patients were fit to lotrafilcon A lenses, randomized to use either a multipurpose solution or a hydrogen peroxide care system, and followed up for 1 year. Lenses, lens transport saline, lids, conjunctivae, and storage cases were cultured and considered to have substantial microbial bioburden when they harbored high levels of commensal or pathogenic organisms. Univariate and multivariate logistic regression analyses were conducted to examine which demographic covariates were associated with significant bioburden at each location while controlling for solution use., Results: In multivariate analyses, smoking trended toward an association with lens bioburden (odds ratio [OR]=2.15, 95% confidence interval [CI]: 0.95-4.88). Clerical occupations were found to be associated with more frequent overall storage case contamination (OR=3.51, 95% CI: 1.15-10.70) and, specifically, higher gram-positive storage case contamination (OR=5.57, 95% CI: 1.82-17.06). The peroxide system was associated with more frequent storage case contamination (OR=7.6, 95% CI: 3.79-15.19). Coagulase-negative staphylococci (CNS) were the most frequently cultured organisms within storage cases, and in multivariate analyses, CNS were more frequently found in storage cases of peroxide users (OR=6.12, 95% CI: 2.91-13.09)., Conclusions: Clerical occupations were associated with increased microbial bioburden of storage cases during daily wear of silicone hydrogel lenses. Smoking may increase the risk of lens contamination. Storage cases are most frequently contaminated with normal skin flora, and peroxide cases were associated with more frequent contamination. However, the solution type was not associated with lid or lens contamination nor with corneal infiltrative events in this study.
- Published
- 2014
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31. Application of senofilcon a contact lenses for therapeutic bandage lens indications.
- Author
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Shafran T, Gleason W, Osborn Lorenz K, and Szczotka-Flynn LB
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Occlusive Dressings, Pain Management, Retrospective Studies, Young Adult, Contact Lenses, Hydrophilic, Corneal Diseases therapy, Hydrogels, Silicones
- Abstract
Purpose: To conduct a retrospective consecutive chart review of senofilcon A contact lenses when used for therapeutic or bandage lens applications. Indication for use includes corneal protection from exposure or repeated irritation, corneal pain relief, and barrier protection. Outcome assessments included pain relief, improvement in corneal signs, additional complications, and overall treatment success., Methods: A total of 43 fully consented patients across 3 different clinical practices in the United States (Georgia, Florida and Ohio) were included in this study. Subjects enrolled in the study were identified by site investigators as their most recent 15 to 20 patients fit in senofilcon A lenses for the listed therapeutic indications. The cases were reviewed to assess the therapeutic success of the lens for the outcomes listed earlier., Results: All lenses fit had an 8.4-mm base curve and 14.0 mm diameter. Patients were fit for pain relief in 26 of the 43 cases of which 81% were judged to be fully effective, 8% partially effective, and 11% ineffective. Improvement in corneal integrity was the treatment goal in 25 cases and was fully effective in 64%, partially effective in 24%, and no change was noted in 12% of the cases. Twelve refractive surgical patients (laser-assisted in situ keratomileusis, epithelial laser-assisted in situ keratomileusis, laser-assisted subepithelial keratectomy, or photorefractive keratectomy) wore the lenses successfully for 4 to 6 days postoperatively for comfort and protection without complications. Investigators judged the overall treatment as fully successful in 68% cases, partially successful in 18% cases, and neutral or unsuccessful in 14% cases. No adverse events were reported in any case., Conclusions: Senofilcon A contact lenses are successful in the majority of cases when used for providing protection of corneal exposure and recurrent damage, pain management, barrier protection, and postsurgical management.
- Published
- 2013
- Full Text
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32. Subclinical increased anterior stromal reflectivity with topical taprenepag isopropyl.
- Author
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Schachar RA, Raber S, Thomas KV, Benetz BA, Szczotka-Flynn LB, Zhang M, Howell SJ, and Lass JH
- Subjects
- Acetates therapeutic use, Administration, Topical, Aged, Aged, 80 and over, Cell Count, Corneal Diseases diagnosis, Corneal Keratocytes drug effects, Corneal Keratocytes pathology, Corneal Pachymetry, Corneal Stroma pathology, Cross-Over Studies, Double-Blind Method, Drug Therapy, Combination, Endothelium, Corneal drug effects, Epithelium, Corneal drug effects, Glaucoma, Open-Angle diagnosis, Humans, Latanoprost, Microscopy, Confocal, Middle Aged, Ocular Hypertension diagnosis, Ocular Hypertension drug therapy, Ophthalmic Solutions, Prostaglandins F, Synthetic therapeutic use, Refraction, Ocular physiology, Sulfonamides therapeutic use, Visual Acuity physiology, Acetates adverse effects, Corneal Diseases chemically induced, Corneal Stroma drug effects, Glaucoma, Open-Angle drug therapy, Receptors, Prostaglandin E, EP2 Subtype agonists, Sulfonamides adverse effects
- Abstract
Purpose: To assess the effect of topical taprenepag isopropyl on each layer of the cornea by confocal microscopy., Methods: Thirty-two ocular hypertensive or glaucoma patients were randomized into a 2-period, crossover study of 14 days of 0.1% taprenepag alone and in unfixed combination with 0.005% latanoprost (combination therapy). Baseline and sequential slit-lamp biomicroscopy, fluorescein staining, central ultrasonic pachymetry, and confocal microscopy were performed. Confocal images were analyzed for the density of the central superficial and basal epithelium, midstromal keratocytes, and endothelium, as well as endothelial coefficient of variation and percentage of hexagonal cells, and reflectivity of anterior stromal and midstromal layers., Results: Corneal staining increased from baseline, reaching a peak at day 13 (69% and 63% of subjects treated with monotherapy and combination therapy, respectively), which resolved by day 35. A statistically significant increase in mean corneal thickness for both eyes and both treatments occurred on days 7 and 13 (range, 20-27 μm; P < 0.001) but recovered (≤ 6 μm) by day 35. No statistically significant changes were observed in the basal epithelial, midstromal, or endothelial cells. Mean ratio of average reflectivity of anterior stroma to midstroma increased on days 13 and 35 in period 1 for each treatment (range, 1.2-1.9; P < 0.001), and this increase persisted during period 2., Conclusions: Anterior stromal reflectivity may remain increased even when biomicroscopic and confocal images of corneal layers remain normal or have recovered after topical taprenepag. This subclinical measure may be useful to detect a persistent adverse effect of a topical agent on the cornea.
- Published
- 2013
- Full Text
- View/download PDF
33. Microbial contamination of contact lenses, lens care solutions, and their accessories: a literature review.
- Author
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Szczotka-Flynn LB, Pearlman E, and Ghannoum M
- Subjects
- Bacteria isolation & purification, Biofilms, Eye microbiology, Gram-Negative Bacteria isolation & purification, Humans, Keratitis etiology, Keratitis microbiology, Orthokeratologic Procedures adverse effects, Staphylococcus isolation & purification, Contact Lens Solutions, Contact Lenses microbiology, Drug Contamination, Equipment Contamination prevention & control
- Abstract
Purpose: A contact lens (CL) can act as a vector for microorganisms to adhere to and transfer to the ocular surface. Commensal microorganisms that uneventfully cohabitate on lid margins and conjunctivae and potential pathogens that are found transiently on the ocular surface can inoculate CLs in vivo. In the presence of reduced tissue resistance, these resident microorganisms or transient pathogens can invade and colonize the cornea or conjunctiva to produce inflammation or infection., Methods: The literature was reviewed and used to summarize the findings over the last 30 years on the identification, enumeration, and classification of microorganisms adherent to CLs and their accessories during the course of normal wear and to hypothesize the role that these microorganisms play in CL infection and inflammation., Results: Lens handling greatly increases the incidence of lens contamination, and the ocular surface has a tremendous ability to destroy organisms. However, even when removed aseptically from the eye, more than half of lenses are found to harbor microorganisms, almost exclusively bacteria. Coagulase-negative Staphylococci are most commonly cultured from worn lenses; however, approximately 10% of lenses harbor Gram-negative and highly pathogenic species, even in asymptomatic subjects. In storage cases, the incidence of positive microbial bioburden is also typically greater than 50%. All types of care solutions can become contaminated, including up to 30% of preserved products., Conclusions: The process of CL-related microbial keratitis and inflammation is thought to be preceded by the presence or transfer or both of microorganisms from the lens to the ocular surface. Thus, this detailed understanding of lens-related bioburden is important in the understanding of factors associated with infectious and inflammatory complications. Promising mechanisms to prevent bacterial colonization on lenses and lens cases are forthcoming, which may decrease the incidence of microbially driven CL complications.
- Published
- 2010
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34. Increased resistance of contact lens-related bacterial biofilms to antimicrobial activity of soft contact lens care solutions.
- Author
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Szczotka-Flynn LB, Imamura Y, Chandra J, Yu C, Mukherjee PK, Pearlman E, and Ghannoum MA
- Subjects
- Anti-Bacterial Agents standards, Biofilms growth & development, Contact Lens Solutions standards, Drug Resistance, Bacterial, Humans, Hydrogel, Polyethylene Glycol Dimethacrylate, Hydrogels, Microscopy, Confocal, Microscopy, Electron, Scanning, Plankton drug effects, Plankton physiology, Pseudomonas aeruginosa drug effects, Pseudomonas aeruginosa physiology, Serratia marcescens drug effects, Serratia marcescens physiology, Silicones, Staphylococcus aureus drug effects, Time Factors, Anti-Bacterial Agents pharmacology, Bacterial Physiological Phenomena, Biofilms drug effects, Contact Lens Solutions pharmacology, Contact Lenses, Hydrophilic microbiology, Staphylococcus aureus physiology
- Abstract
Purpose: To determine if clinical and reference strains of Pseudomonas aeruginosa, Serratia marcescens, and Staphylococcus aureus form biofilms on silicone hydrogel contact lenses and ascertain antimicrobial activities of contact lens care solutions., Methods: Clinical and American Type Culture Collection reference strains of P. aeruginosa, S. marcescens, and S. aureus were incubated with lotrafilcon A lenses under conditions that facilitate biofilm formation. Biofilms were quantified by quantitative culturing (colony-forming units, CFUs), and gross morphology and architecture were evaluated using scanning electron microscopy and confocal microscopy. Susceptibilities of the planktonic and biofilm growth phases of the bacteria to 5 common multipurpose contact lens care solutions and 1 hydrogen peroxide care solution were assessed., Results: Pseudomonas aeruginosa, S. marcescens, and S. aureus reference and clinical strains formed biofilms on lotrafilcon A silicone hydrogel contact lenses, as dense networks of cells arranged in multiple layers with visible extracellular matrix. The biofilms were resistant to commonly used biguanide-preserved multipurpose care solutions. Pseudomonas aeruginosa and S. aureus biofilms were susceptible to a hydrogen peroxide and a polyquaternium-preserved care solution, whereas S. marcescens biofilm was resistant to a polyquaternium-preserved care solution but susceptible to hydrogen peroxide disinfection. In contrast, the planktonic forms were always susceptible., Conclusion: Pseudomonas aeruginosa, S. marcescens, and S. aureus form biofilms on lotrafilcon A contact lenses, which in contrast to planktonic cells are resistant to the antimicrobial activity of several soft contact lens care products.
- Published
- 2009
- Full Text
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35. Menicon Z rigid gas permeable lenses for keratoconus and irregular corneas: a retrospective case series.
- Author
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Szczotka-Flynn LB and Patel S
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Follow-Up Studies, Humans, Keratoconus pathology, Male, Middle Aged, Oxygen metabolism, Prosthesis Fitting, Retrospective Studies, Time Factors, Young Adult, Contact Lenses, Cornea pathology, Keratoconus rehabilitation, Methylmethacrylates, Silicones
- Abstract
Purpose: The tisilfocon A (Menicon Z) rigid gas permeable (RGP) contact lens polymer has the highest oxygen permeability (Dk) value of any RGP lens material. To our knowledge there is no published literature documenting the success of this material in fitting contact lenses to highly irregular and diseased corneas., Methods: A retrospective medical record review of 40 consecutive patients (64 eyes) who had worn lenses made in the Menicon Z RGP material was performed. All patients had some form of corneal pathology and were fitted in a single tertiary care hospital-based contact lens service., Results: Menicon Z contact lenses were fit to 33 eyes of 20 patients with keratoconus (KC) and 31 eyes of 23 patients with irregular corneas. The irregular cornea group comprised 28 eyes of 21 patients after corneal surgery, 1 eye with ocular cicatricial pemphigoid and 2 eyes of 1 patient with chronic staphylococcal blepharo-keratoconjuncitivitis. Treatment goals included acceptable corneal physiology, comfort, and visual acuity. In the KC group, there was an 82% (27/33 eyes) success rate as measured by the treatment goals. Mean duration of wear for successful patients was 2.5 years (0.5-5 years). Only 12% (4/33 eyes) failed directly due to inability of the Menicon Z material to perform adequately while another material was acceptable. In the irregular surface group (surgical and ocular surface disease), there was a 74% (23/31 eyes) success rate. Mean duration of wear for successful patients in this group is 2.79 years (3 months-7 years). Only 3% (1/31 eyes) failed directly due to inability of the Menicon Z material to perform adequately while another material was acceptable., Conclusions: The tisilfocon A hyper Dk lens material maintains clinically acceptable corneal health and clinically acceptable visual acuity for patients with KC and irregular corneal surfaces. In this series of patients with complicated corneal disease, the most failures were due to design issues and discomfort not related to the Menicon Z material. The Menicon Z material was inadequate in only 8% of eyes, whereas another RGP material was successful. Most patients with irregular corneas in a tertiary care center can be successfully fit with the tisilfocon A RGP material for visual rehabilitation.
- Published
- 2008
- Full Text
- View/download PDF
36. Fusarium and Candida albicans biofilms on soft contact lenses: model development, influence of lens type, and susceptibility to lens care solutions.
- Author
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Imamura Y, Chandra J, Mukherjee PK, Lattif AA, Szczotka-Flynn LB, Pearlman E, Lass JH, O'Donnell K, and Ghannoum MA
- Subjects
- Biofilms drug effects, Candida albicans drug effects, Candida albicans genetics, Contact Lenses, Hydrophilic classification, Culture Media, Fusarium drug effects, Fusarium genetics, Humans, Keratitis microbiology, Microbial Sensitivity Tests, Models, Biological, Molecular Sequence Data, Polymers chemistry, Sequence Analysis, DNA, Biofilms growth & development, Candida albicans growth & development, Contact Lens Solutions classification, Contact Lens Solutions pharmacology, Contact Lenses, Hydrophilic microbiology, Fusarium growth & development
- Abstract
Fungal keratitis is commonly caused by Fusarium species and less commonly by Candida species. Recent outbreaks of Fusarium keratitis were associated with contact lens wear and with ReNu with MoistureLoc contact lens care solution, and biofilm formation on contact lens/lens cases was proposed to play a role in this outbreak. However, no in vitro model for contact lens-associated fungal biofilm has been developed. In this study, we developed and characterized in vitro models of biofilm formation on various soft contact lenses using three species of Fusarium and Candida albicans. The contact lenses tested were etafilcon A, galyfilcon A, lotrafilcon A, balafilcon A, alphafilcon A, and polymacon. Our results showed that clinical isolates of Fusarium and C. albicans formed biofilms on all types of lenses tested and that the biofilm architecture varied with the lens type. Moreover, differences in hyphal content and architecture were found between the biofilms formed by these fungi. We also found that two recently isolated keratitis-associated fusaria formed robust biofilms, while the reference ATCC 36031 strain (recommended by the International Organization for Standardization guidelines for testing of disinfectants) failed to form biofilm. Furthermore, using the developed in vitro biofilm model, we showed that phylogenetically diverse planktonic fusaria and Candida were susceptible to MoistureLoc and MultiPlus. However, Fusarium biofilms exhibited reduced susceptibility against these solutions in a species- and time-dependent manner. This in vitro model should provide a better understanding of the biology and pathogenesis of lens-related fungal keratitis.
- Published
- 2008
- Full Text
- View/download PDF
37. Repeatability of corneal topography measurement in keratoconus with the TMS-1.
- Author
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McMahon TT, Anderson RJ, Roberts C, Mahmoud AM, Szczotka-Flynn LB, Raasch TW, Friedman NE, and Davis LJ
- Subjects
- Algorithms, Humans, Reproducibility of Results, Cornea pathology, Corneal Topography instrumentation, Keratoconus diagnosis
- Abstract
Purpose: The purpose of this study was to report the test-retest variability of simulated indices derived from the TMS-1 topography instrument (Tomey Technology, Waltham, MA) in keratoconus subjects enrolled in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study., Methods: Four images were taken at an initial visit and at a repeat visit several weeks later. From these images, 17 indices were simulated from published formulas. Mixed-model analysis was used on test-retest data from the TMS-1 videokeratography instrument during the baseline year. This analysis yields estimates of within- and between-visit variability., Results: Repeatability analysis revealed that within-visit standard errors were 1.0 to 5.9 times greater in keratoconus eyes than in normal controls when two images were analyzed from each visit. These values changed only slightly when more images were used. The ratio of between-visit standard errors of the indices were nearly equally greater than normal controls for (0.9-4.6 and 0.9-4.3) two images per eye and all images per eye, respectively., Conclusions: These results suggest that the repeatability of simulated indices derived from TMS-1 topography in keratoconus subjects is poorer than in normal controls.
- Published
- 2005
- Full Text
- View/download PDF
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