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Excellent outcomes can be obtained with topography-guided LASIK using Contoura Vision when the Phorcides Analytical Engine is used to program the WaveLight EX500 excimer laser. Purpose: To evaluate prospectively the clinical outcomes of topography-guided laser in situ keratomileusis (LASIK) surgery performed with Contoura Vision using the Wavelight excimer laser and planned with the Phorcides Analytical Engine. Setting: Four clinical practices in the U.S. Design: Prospective single-arm interventional study. Methods: 130 eyes of 65 patients with myopia or myopic astigmatism were enrolled in a prospective study of visual and refractive outcomes after treatment with Contoura Vision using the Wavelight EX500 excimer laser to achieve optimal distance vision. At 3 months postoperatively, uncorrected distance visual acuity (UDVA), manifest refraction, and corrected distance visual acuity (CDVA) were measured and compared with previously published studies. Results: At 3 months postoperatively, 100%, 89%, and 28% of eyes achieved UDVA of 20/20, 20/15, and 20/12.5 or better, respectively. 92% of eyes had postoperative UDVA equal to or better than their preoperative CDVA. Postoperative CDVA was equal to, 1 line better, or 2 lines better than the preoperative CDVA in 53%, 40%, and 6% of eyes, respectively. Only 1 eye lost 1 line of CDVA, and no eyes lost more than 1 line of CDVA. A statistically significant decrease was noted in subjective visual complaints, including glare, halos, difficulty driving at night, reading difficulty, starbursts, fluctuation in vision, and light sensitivity. Conclusions: The Phorcides Analytical Engine can be used to optimize visual outcomes for the correction of myopia and myopic astigmatism. [ABSTRACT FROM AUTHOR]

Purpose: To identify the laser programming strategy that will achieve optimal refractive outcomes of LASIK with a topography-guided laser for eyes with a disparity between cylinder measured by manifest refraction and cylinder measured by topography. Setting: Six surgeons at 5 clinical sites in the USA. Design: Retrospective data review. Methods: Preoperative, treatment, and postoperative data on 52 eyes that underwent topography-guided LASIK with the WaveLight EX500 Contoura® Vision excimer laser ablation profile in which the vectors representing the preoperative refractive cylinder and the cylinder measured by the WaveLight® Topolyzer™ VARIO Diagnostic Device (Vario cylinder) differed by >/= 0.50D and/or >/= 10 degrees of orientation were analyzed retrospectively. Data were contributed by six surgeons using the laser at 5 different clinical sites. Vector analysis of postoperative cylindrical refractive error and the actual laser programming strategy was used to calculate the cylindrical correction that would, theoretically, have completely eliminated postoperative refractive cylinder. This was compared to expected results using the preoperative manifest cylinder, the topographic cylinder, and the Phorcides Analytic Engine (Phorcides LLC, North Oaks MN; Phorcides). For analysis, subjects were stratified on the basis of the vector difference between Manifest and Topo cylinder (High, > 0.75 D; and Low, ≤ 0.75 D). Results: The poorest calculated theoretical outcomes were obtained with the manifest refraction (centroid: − 0.43, 0.22; mean calculated error vector: 0.56 ± 0.42 D; p=ns). Better outcomes were obtained with the topographically measured refraction (centroid: 0.37, 0.02; mean calculated error vector: 0.47 ± 0.33 D; p=ns). The best outcomes were obtained with Phorcides (centroid: − 0.15, 0.06; mean calculated error vector: 0.39 ± 0.28 D; p=ns). The mean error vector magnitude in the Phorcides Low group was significantly lower than for the Manifest and Topo Low groups (0.26 D vs 0.48 D and 0.33 D; p< 0.01). The mean error magnitude in the Phorcides High group was nearly 0.25 D lower than for the Manifest High group (0.48 D vs 0.70 D; p< 0.01), but was the same as for the Topo High group (0.48 D vs 0.48 D). Conclusion: Our study suggests that using the topographically measured cylinder or the cylinder selected by Phorcides will produce more desirable refractive outcomes than entry of the preoperative refractive cylinder as the basis for correction of myopia and myopic astigmatism with the WaveLight Contoura Vision excimer laser. [ABSTRACT FROM AUTHOR]

To study eyes with 20/10 uncorrected distance visual acuity (UDVA) 3 months and 12 months after topography-guided LASIK for myopia and myopic astigmatism, and to identify factors predictive of this excellent level of visual acuity. Nine practices in the USA. Prospective unmasked study of safety and effectiveness. The percentage of eyes with UDVA of 20/10 or better at 3 months and 12 months after topography-guided laser in situ keratomileusis (LASIK) with the Contoura Vision excimer laser in a U.S. Food and Drug Administration clinical trial was compared, and possible contributing factors were investigated. Preoperatively, only 1% of eyes had 20/10 corrected distance visual acuity (CDVA). Postoperatively, 7.0% of eyes had 20/10 or better UDVA at 3 months, and this number increased to 16% at 12 months (odds ratio, 2.48; 95% confidence interval, 1.33-4.61). The lower preoperative corneal astigmatism and postoperative refractive cylinder correlated with better postoperative UDVA and CDVA, respectively (P <.01 in all cases). The postoperative UDVA correlated with the postoperative CDVA (P <.01). The number of eyes with UDVA of 20/10 increases significantly between 3 months and 12 months after topography-guided LASIK and correlates with better postoperative CDVA. Eyes with lower preoperative corneal astigmatism are more likely to achieve 20/10 or better UDVA postoperatively. A significant improvement in the number of eyes with 20/10 or better from 3 months to 12 months after LASIK might be unique to topography-guided treatment. [ABSTRACT FROM AUTHOR]

Purpose To evaluate the effect of riboflavin–ultraviolet (UV)-A corneal crosslinking (CXL) without epithelial removal on ectatic corneal disease. Setting Woolfson Eye Institute, Atlanta, Georgia, USA. Design Prospective observational study. Methods Patients were treated with a new riboflavin formulation without epithelial removal, then exposed to UV light (365 nm) at 4 mW/cm2 with on-off cycling for 30 minutes. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, maximum corneal curvature (maximum keratometry [Kmax]), total higher-order aberrations (HOAs), and coma were measured at 3, 6, 12, and 24 months postoperatively. Progression was defined as an increase of more than 1 diopter (D) in Kmax and loss of more than 1 line of CDVA. Results Five hundred twelve eyes of 308 patients with keratoconus or forme fruste keratoconus and 80 eyes of 55 patients with ectasia after laser in situ keratomileusis (LASIK) were treated with the new riboflavin formulation without epithelial removal; 229 patients received bilateral treatments, 95 of which were simultaneous. The mean UDVA and CDVA improved by 1 to 1.5 Snellen lines at 1 and 2 years postoperatively (P <.0001). Mean Kmax decreased by 0.48 D at 2 years postoperatively (P =.0002). Mean total HOAs and coma decreased by 36% (P <.0001) and 37% (P =.0002), respectively, at 2 years postoperatively. Kmax decreased more than 1 D in three times as many eyes as it increased more than 1 D (P <.0001). No eyes progressed, and there was no loss of effect between 1 and 2 years postoperatively. No vision-threatening events were observed. Pain typically resolved within 24 hours, and visual acuity returned to preoperative levels in 1 to 2 days. Conclusion Epithelium-on CXL using this new protocol halted the progression of keratoconus and ectasia after LASIK. It was safer and provided more rapid visual recovery than CXL with epithelial removal, allowing routine bilateral, simultaneous treatment. [ABSTRACT FROM AUTHOR]

Purpose To compare the corneal stromal riboflavin concentration and distribution using 2 transepithelial corneal crosslinking (CXL) systems. Setting Absorption Systems, San Diego, California, USA. Design Experimental study. Methods The stromal riboflavin concentration of 2 transepithelial CXL systems was compared in rabbit eyes in vivo. The systems were the Paracel/Vibex Xtra, comprising riboflavin 0.25% solution containing TRIS and ethylenediaminetetraacetic acid and an isotonic solution of riboflavin 0.25%, (Group 1) and the CXLO system (Group 2). Manufacturers’ Instructions For Use were followed. The intensity of riboflavin fluorescence by slitlamp observation 10, 15, and 20 minutes after instillation was graded on a scale of 0 to 5. The animals were humanely killed and the corneal stromal samples analyzed with liquid chromatography and mass spectrometry. Results The mean riboflavin fluorescence intensity grades in Group 1 (4 eyes) were 3.8, 4.8, and 4.8 at 10, 15, and 20 minutes, respectively. The mean grades in Group 2 (3 eyes) were 2.0, 2.3, and 2.0, respectively. The riboflavin distribution was uniform in Group 1 but not in Group 2. The mean riboflavin concentration by liquid chromatography and mass spectrometry was 27.0 μg/g stromal tissue in Group 1 and 6.7 μg/g in Group 2. A stromal riboflavin concentration theoretically adequate for CXL, 15 μg/g, was achieved in all eyes in Group 1 and no eyes in Group 2. Slitlamp grading correlated well with liquid chromatography and mass spectrometry concentration ( R 2 = 0.940). Conclusions The system used in Group 1 produced corneal riboflavin concentrations that were theoretically adequate for effective transepithelial CXL (≥15 μg/g), while the system in Group 2 did not. Slitlamp grading successfully estimated the corneal riboflavin concentration and can be used to ensure an adequate concentration of riboflavin in the cornea for transepithelial CXL. [ABSTRACT FROM AUTHOR]

Purpose To evaluate the safety and efficacy of corneal collagen crosslinking (CXL) for the treatment of corneal ectasia after laser refractive surgery. Design Prospective, randomized, multicenter, controlled clinical trial. Participants One hundred seventy-nine subjects with corneal ectasia after previous refractive surgery. Methods The treatment group underwent standard CXL, and the sham control group received riboflavin alone without removal of the epithelium. Main Outcome Measures The primary efficacy criterion was the change over 1 year of topography-derived maximum keratometry (K), comparing treatment with control groups. Secondary outcomes evaluated were corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), manifest refraction spherical equivalent, endothelial cell count, and adverse events. Results In the crosslinking treatment group, the maximum K value decreased by 0.7 diopters (D) from baseline to 1 year, whereas there was continued progression in the control group (1.3 D difference between treatment and control, P < 0.0001). In the treatment group, the maximum K value decreased by 2.0 D or more in 14 eyes (18%) and increased by 2.0 D or more in 3 eyes (4%). The CDVA improved by an average of 5.0 logarithm of the minimum angle of resolution (logMAR) letters. Twenty-three eyes (32%) gained and 3 eyes (4%) lost 10 or more logMAR letters. The UDVA improved 4.5 logMAR letters. Corneal haze was the most frequently reported crosslinking-related adverse finding. Conclusions Corneal collagen crosslinking was effective in improving the maximum K value, CDVA, and UDVA in eyes with corneal ectasia 1 year after treatment, with an excellent safety profile. CXL is the first approved procedure to diminish progression of this ectatic corneal process. [ABSTRACT FROM AUTHOR]

Purpose To evaluate the safety and efficacy of corneal collagen crosslinking (CXL) for the treatment of progressive keratoconus. Design Prospective, randomized, multicenter, controlled clinical trial. Participants Patients with progressive keratoconus (n = 205). Methods The treatment group underwent standard CXL and the sham control group received riboflavin alone without removal of the epithelium. Main Outcome Measures The primary efficacy criterion was the change over 1 year of topography-derived maximum keratometry value, comparing treatment with control group. Secondary outcomes evaluated were corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), manifest refraction spherical equivalent, endothelial cell count, and adverse events. Results In the CXL treatment group, the maximum keratometry value decreased by 1.6 diopters (D) from baseline to 1 year, whereas keratoconus continued to progress in the control group. In the treatment group, the maximum keratometry value decreased by 2.0 D or more in 28 eyes (31.4%) and increased by 2.0 D or more in 5 eyes (5.6%). The CDVA improved by an average of 5.7 logarithm of the minimum angle of resolution (logMAR) units. Twenty-three eyes (27.7%) gained and 5 eyes lost (6.0%) 10 logMAR or more. The UDVA improved 4.4 logMAR. Corneal haze was the most frequently reported CXL-related adverse finding. There were no significant changes in endothelial cell count 1 year after treatment. Conclusions Corneal collagen crosslinking was effective in improving the maximum keratometry value, CDVA, and UCVA in eyes with progressive keratoconus 1 year after treatment, with an excellent safety profile. Corneal collagen crosslinking affords the keratoconic patient an important new option to decrease progression of this ectatic corneal process. [ABSTRACT FROM AUTHOR]

Purpose To evaluate the safety and effectiveness of topography-guided custom ablation treatment (T-CAT) to correct myopia and myopic astigmatism with laser in situ keratomileusis (LASIK). Setting Nine clinical sites in the USA. Design Prospective observational nonrandomized unmasked study. Methods The study comprised patients aged 18 to 65 years old with myopia or myopic astigmatism with a manifest refraction spherical equivalent (MRSE) up to −9.0 diopters (D) and astigmatism of 6.0 D or less. Patients with previous refractive surgery or abnormal topography were excluded. Corneal topographies were obtained using the Allegro Topolyzer, and laser treatment was delivered with the Allegretto Wave Eye-Q excimer laser system. Visual outcomes were evaluated postoperatively at 1 day, 1 week, and 1, 3, 6, 9, and 12 months. Results The clinical trial enrolled 212 patients (249 eyes). The T-CAT procedure significantly reduced the MRSE and cylinder, with stability of outcomes evident from 3 to 12 months after surgery. Compared with the preoperative corrected distance visual acuity (CDVA), the postoperative uncorrected distance visual acuity (UDVA) improved by 1 line or more in 30% of eyes and the postoperative UDVA was at least as good as the preoperative CDVA in 90% of eyes. Most visual symptoms improved after T-CAT. There were no significant treatment-related adverse events or loss of vision. Conclusion The T-CAT procedure performed with the diagnostic device and the refractive excimer laser system safely and effectively achieved predictable refractive outcomes and reduced visual symptoms with stable results through 12 months. Financial Disclosure Dr. Stulting is a paid consultant to Alcon Laboratories, Inc., and was a medical monitor for the U.S. Food and Drug Administration (FDA) clinical trial. Dr. Fant is president of Clinical Research Consultants, Inc. (CRC), the clinical and regulatory consulting group that sponsored the FDA clinical trial. Dr. Fant and CRC were supported by Alcon Laboratories, Inc. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate long-term safety and best-corrected visual acuity (BCVA) results of a telescope prosthesis in patients with end-stage age-related macular degeneration (AMD). Design: Prospective, open-label clinical trial with fellow-eye controls. Methods: Patients with end-stage AMD (bilateral geographic atrophy or disciform scars; BCVA, 20/80 to 20/800) received the telescope prosthesis at 28 centers. Methods were similar to those described in the one-year results, with follow-up visits continuing at 18 and 24 months. Main outcome measures included BCVA change from baseline, endothelial cell density (ECD) and morphometry, and incidence of complications. Results: At two years, data from 174 (92.6%) of 188 available patients were analyzed. Overall, 103 (59.5%) of 173 telescope-implanted eyes gained three lines or more (doubling of visual angle) of BCVA compared with 18 (10.3%) of 174 fellow control eyes (P < .0001). Mean BCVA improved 3.6 lines (standard deviation [SD], 1.9 lines) and 2.8 lines (SD, 2.3 lines) from baseline in eyes with the 3X and 2.2X device models, respectively. Mean ECD stabilized through two years, with 2.4% mean cell loss occurring from one to two years. There was no significant change in coefficient of variation or percentage of hexagonal endothelial cells from within six months to two years after surgery. The most common complication was inflammatory deposits. Conclusions: Long-term results of this telescope prosthesis show the substantial BCVA improvement at one year is maintained at two years. Key indicators of corneal health demonstrate ECD change that reflects remodeling of the endothelium associated with the implantation procedure. ECD stabilizes over time, and there is no evidence of any ongoing endothelial trauma. [Copyright &y& Elsevier]

Objective: To assess the safety and efficacy of the Artisan/Verisyse phakic intraocular lens (IOL) for the correction of high myopia. Design: Prospective, open-label, noncomparative, multicenter clinical trial. Participants: A total of 684 adults with axial myopia from −4.5 diopters (D) to −22 D were enrolled: 662 in the primary analysis group and 22 under compassionate use protocol expansion. Efficacy data are based on the 662 first eyes implanted. Intervention: Implantation of the Artisan/Verisyse phakic intraocular lens. Main Outcome Measures: Efficacy measures included uncorrected distance visual acuity (UCVA), refractive predictability and stability, patient satisfaction, and contrast sensitivity. Safety measures were best spectacle-corrected visual acuity (BSCVA), intraocular pressure, slit-lamp observations, endothelial cell density (ECD), complications, and adverse events. Results: At 3 years, UCVAs for first eyes were 20/40 or better in 84.0% (194/231) and 20/25 or better in 51.9% (120/231). Of first eyes, 71.7% to 76.7% were within 0.50 D of target refraction and 93.1% to 95.0% were within 1.0 D at 6 months and later. Best spectacle-corrected visual acuity was 20/40 or better for 99% to 100% of first eyes from the 1-month visit through 3 years. At 3 years, 54% of first eyes gained ≥1 lines of BSCVA, and 7.5% lost ≥1 lines of BSCVA. The mean change in ECD from baseline to 3 years was −4.8%±7.8%, with a 2.4% loss between 2 and 3 years. One site had a mean cell loss of −5.0% (P = 0.023), and the others combined had a mean cell loss of 1.7%±5.4%. For a cohort of 57 eyes with ECD data for all visits, the mean change from baseline was −3.8%±9.8% over 3 years. Approximately half (31/59) of the adverse events and preventative repositionings were among the first 10 cases performed by each investigator. Conclusions: The Artisan/Verisyse phakic IOL provides excellent refractive outcomes; endothelial cell loss within a mean of 5.0% over 3 years, or 1.8% per year; and few complications. [Copyright &y& Elsevier]

Objective: To study the relationship between intraocular pressure (IOP) readings after LASIK and the amount of refractive correction. Design: Retrospective noninterventional case series. Participants: Patients receiving primary LASIK for myopia and myopic astigmatism. Methods: A database of preoperative, intraoperative, and 3-month postoperative data for 8113 consecutive eyes that underwent primary myopic and myopic astigmatic LASIK was retrospectively reviewed. Linear regression analysis of measured IOP change as a function of refractive change was then performed. Age and preoperative keratometry were also reviewed by multiple regression. Main Outcome Measures: Best-fit curve relating change in measured IOP to refractive change. Results: The mean spherical equivalent of the refractive change was –4.98±2.64 diopters (mean ± standard deviation). The mean decrease in measured IOP was 2.0±3.3 mmHg. Linear regression analysis revealed a decrease of 0.12 mmHg of measured IOP per diopter of refractive change (95% confidence interval [CI], 0.09–0.15, R 2 = 0.009, P&#60;0.001). Extrapolation of the data to a theoretical correction of zero diopters revealed a decrease of 1.36 mmHg (95% CI, 1.20–1.51, P&#60;0.001), suggesting a component of measured IOP change that is independent of laser ablation. Conclusions: The reduction of IOP readings after corneal refractive surgery is a linear function of the amount of refractive correction, with an additional constant reduction that is probably related to the lamellar corneal flap. These data suggest that the lamellar corneal flap makes no contribution to the load-bearing characteristics of the post-LASIK cornea. [Copyright &y& Elsevier]

The article discusses research on the long-term efficacy and safety of implantable miniature telescope prosthesis (IMT) in individuals with end-stage age-related macular degeneration. It references a study by Henry L. Hudson and colleagues, published in the 2008 issue of "American Journal of Ophthalmology." It relates the methodology and outcome measures of the study, which include best-corrected visual acuity (BCVA) change from baseline, endothelial cell density (ECD), and morphometry and the incidence of other complications.

Purpose: We evaluate the long-term visual, refractive, and keratometric outcomes after corneal crosslinking (CXL) in patients with progressive keratoconus (KC) and the incidence of an extreme corneal flattening effect.Settings: Oftalmosalud Institute of Eyes, Lima, Perú.Design: Retrospective cohort study.Methods: Forty-five eyes that underwent CXL with epithelial removal between June 2006 and September 2011. Data analysis was performed at preoperative evaluation, 1 year postoperatively, and at least 10 years or more postoperatively. Outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and Scheimpflug (Pentacam) analysis. Progression was defined by an increase in steep keratometry (Ks) of 1.5D or greater between 2 examinations. Extreme flattening effect was defined as a decrease in K values equal to or greater than 5 diopters (D).Results: Mean follow-up time was 11 ± 1.07 years (range 10– 13 years). There was a significant improvement in Ks, UCVA, CDVA, and spherical equivalent at the last visit. The overall rate of progression was 2.22% (1/45). Extreme flattening was observed in 15.5% (7/45) of the eyes, and this was associated with a loss of CDVA in 4.44% (2/45) of the eyes. One eye with corneal flattening of 11.5 D lost 7 lines of CDVA and required corneal transplantation.Conclusion: CXL is a safe and effective procedure to stop the progression of KC with a good overall long-term success rate. Extreme corneal flattening may be more common than commonly recognized, and severe corneal flattening associated with a decrease in CDVA may occur. [ABSTRACT FROM AUTHOR]

The writers' reference results they have obtained suggesting that astigmatism measured by manifest refraction is superior to topographically measured astigmatism for surgical planning. This statement is the first sentence of a paragraph that explains how Phorcides calculates lenticular astigmatism. Reply: Clinical and refractive outcomes after topography-guided refractive surgery planned using Phorcides surgery planning software. [Extracted from the article]

Background: Mutations of the transforming growth factor-β-induced (TGFBI) gene produce various types of corneal dystrophy. Here, we report a novel de novo L509P mutation not located in a known hot spot of the transforming growth factor-β-induced (TGFBI) gene and its clinical phenotype, which resembles that of lattice corneal dystrophy type IIIA (LCD IIIA). Case presentation: A 36-year-old man (proband) visited our clinic due to decreased visual acuity with intermittent ocular irritation in conjunction with painful recurrent erosions in both eyes for 10 years. Molecular genetic analyses revealed a TGFBI L509P mutation (c.1526T>C) in the proband and one of his sons. Interestingly, neither TGFBI mutations nor corneal abnormalities were detected in either of the proband's biological parents, indicating the occurrence of a de novo L509P mutation. Clinical examinations, including slit-lamp retro-illumination and Fourier-domain anterior segment optical coherence tomography (FD-OCT), revealed gray deposits in the anterior stroma and deeper refractile lines extending from limbus to limbus in both corneas of the proband, consistent with a diagnosis of LCD IIIA. Superficial diffuse haze and surface irregularity were observed in conjunction with corneal erosions and visual impairment, necessitating phototherapeutic keratectomy (PTK). A 60 μm PTK of the Bowman layer and anterior stroma of the proband's left eye was performed following the removal of the epithelium in order to remove superficial corneal opacities. His BCVA improved from 20/400 to 20/50 at postoperative week 8 and was maintained for 45 months. Pinhole-corrected VA was 20/20 at the last visit, and corneal opacities had not recurred. Conclusions: An inheritable de novo mutation of L509P in the TGFBI gene can produce severe LCD IIIA, which can be successfully treated with OCT-guided PRK. [ABSTRACT FROM AUTHOR]

To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects. Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial. Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both. Eyes were implanted from November 26, 2013, to December 1, 2017, with a custom, foldable artificial iris by 1 of 4 different surgical techniques. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months after surgery. At each examination, slit-lamp findings, intraocular pressure, implant position, subjective visual symptoms, and complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were measured at 3, 6, or 12 months as additional safety evaluations. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale was used to assess cosmetic results. Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, Global Aesthetic Improvement Scale rating, prosthesis-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months after surgery. At the 12-month postoperative examination, a 59.7% reduction in marked to severe daytime light sensitivity (P < 0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (P < 0.0001), a 53.1% reduction in marked to severe daytime glare (P < 0.0001), and a 48.5% reduction in severe nighttime glare (P < 0.0001) were found. A 15.4-point improvement (P < 0.0001) in the NEI VFQ-25 total score was found, and 93.8% of patients reported an improvement in cosmesis as measured by the Global Aesthetic Improvement Scale 12 months after surgery. No loss of CDVA of > 2 lines related to the device was found. Median ECD loss was 5.3% at 6 months after surgery and 7.2% at 12 months after surgery. The artificial iris surpassed all key safety end points for adverse events related to the device, IOL, or implant surgery and met all key efficacy end points, including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects. [ABSTRACT FROM AUTHOR]

Purpose: To compare visual acuity and higher-order aberrations (HOAs) after wavefront-guided and wavefront-optimized laser in situ keratomileusis (LASIK). Methods: This retrospective study comprised refraction-matched myopic eyes that had wavefront-guided (Visx Star S4 laser) or wavefront-optimized (WaveLight Allegretto Wave laser) LASIK targeted for emmetropia. Preoperative and postoperative manifest refraction spherical equivalent (MRSE), uncorrected (UDVA) and corrected (CDVA) distance visual acuities, and preoperative and postoperative HOAs were compared. Results: Preoperatively, there were no significant differences between the wavefront-guided and wavefront-optimized groups in age, sex, corneal thickness, MRSE, or HOAs (all P>.05). The mean MRSE was −2.88 diopters (D) ± 2.6 (SD) and −2.96 ± 2.6 D, respectively, preoperatively and −0.01 ± 0.25 D and −0.02 ± 0.33 D, respectively, postoperatively; 96% of all eyes were within ±0.50 D of emmetropia postoperatively. There were no differences in UDVA, CDVA, MRSE, or HOAs between groups (all P>.05). The UDVA was 20/20 or better in 85% of eyes in the wavefront-guided group and 86% of eyes in the wavefront-optimized group. All eyes had 20/25 or better CDVA postoperatively; no eye lost 2 lines of CDVA. Fourteen eyes were converted from wavefront-guided to wavefront-optimized treatment because of poor limbal ring alignment (8 eyes), a wave scan not consistent with the manifest refraction (5 eyes), and no iris registration (1 eye). Conclusions: Wavefront-guided LASIK and wavefront-optimized LASIK produced equivalent visual outcomes and no differences in HOAs. Wavefront-guided treatment could not be performed in many eyes because of difficulties during wavefront measurement. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes. [Copyright &y& Elsevier]

Purpose: To analyze the reasons for patient dissatisfaction after phacoemulsification with multifocal intraocular lens (IOL) implantation and the outcomes after intervention. Setting: Emory Eye Center, Atlanta, Georgia, USA. Methods: This retrospective review comprised eyes of patients dissatisfied with visual outcomes after multifocal IOL implantation. Outcomes analyzed included type of visual complaint, treatment modality for each complaint, and degree of clinical improvement after intervention. Results: Thirty-two patients (43 eyes) reported unwanted visual symptoms after multifocal IOL implantation, including in 28 eyes (65%) with an AcrySof ReSTOR IOL and 15 (35%) with a ReZoom IOL. Thirty patients (41 eyes) reported blurred vision, 15 (18 eyes) reported photic phenomena, and 13 (16 eyes) reported both. Causes of blurred vision included ametropia (12 eyes, 29%), dry eye syndrome (6 eyes, 15%), posterior capsule opacification (PCO) (22 eyes, 54%), and unexplained etiology (1 eye, 2%). Causes of photic phenomena included IOL decentration (2 eyes, 12%), retained lens fragment (1 eye, 6%), PCO (12 eyes, 66%), dry-eye syndrome (1 eye, 2%), and unexplained etiology (2 eyes, 11%). Photic phenomena attributed to PCO also caused blurred vision. Thirty-five eyes (81%) had improvement with conservative treatment. Five eyes (12%) did not have improvement despite treatment combinations. Three eyes (7%) required IOL exchange. Conclusions: Complaints of blurred vision and photic phenomena after multifocal IOL implantation were effectively managed with appropriate treatment. Few eyes (7%) required IOL exchange. Neodymium:YAG capsulotomy should be delayed until it has been determined that IOL exchange will not be necessary. [Copyright &y& Elsevier]

Purpose: To determine whether corneal graft survival over a 5-year follow-up period was affected by ABO blood type compatibility in participants in the Cornea Donor Study undergoing corneal transplantation principally for Fuchs dystrophy or pseudophakic corneal edema, conditions at low-risk for graft rejection. Design: Multi-center prospective, double-masked, clinical trial. Methods: ABO blood group compatibility was determined for 1,002 donors and recipients. During a 5-year follow-up period, episodes of graft rejection were documented, and graft failures were classified as to whether or not they were attributable to immunologic rejection. Endothelial cell density was determined by a central reading center for a subset of subjects. Results: ABO donor-recipient incompatibility was not associated with graft failure attributable to any cause including graft failure because of rejection, or with the occurrence of a rejection episode. The 5-year cumulative incidence of graft failure attributable to rejection was 32 (6%) for recipients with ABO recipient-donor compatibility and 12 (4%) for those with ABO incompatibility (hazard ratio, 0.65; 95% confidence interval, 0.33 to 1.25; P = .20). The 5-year incidence for a definite rejection episode, irrespective of whether graft failure ultimately occurred, was 64 (12%) for ABO compatible compared with 25 (8%) for ABO incompatible cases (P = .09). Among clear grafts at 5 years, percent loss of endothelial cells was similar in ABO compatible and incompatible cases. Conclusions: In patients undergoing penetrating keratoplasty for Fuchs dystrophy or pseudophakic corneal edema, ABO matching is not indicated since ABO incompatibility does not increase the risk of transplant failure attributable to graft rejection. [Copyright &y& Elsevier]

Purpose: To determine which of 3 methods for measuring preoperative refractive error yields the best refractive outcomes after wavefront-guided (Visx Star S4) or wavefront-optimized (WaveLight Allegretto Wave) excimer laser in situ keratomileusis (LASIK). Setting: Emory Eye Center and Emory Vision, Emory University, Atlanta, Georgia, USA. Methods: This retrospective analysis of LASIK, performed from June to December 2007, analyzed sphere, cylinder, and spherical equivalent (SE) refractions generated from 3 methods (manifest refraction, aberrometer autorefraction [CustomVue WaveScan], corneal analyzer autorefraction [Nidek ARK-10000 OPD]), actual programmed treatment, and absolute deviation from ideal treatment (deviation) for each technique. Results: In the wavefront-guided group (63 eyes, 33 patients), manifest refraction and aberrometer autorefraction generated similar deviation for sphere and SE; both were significantly better than corneal analyzer autorefraction (P = .02 and P = .03, respectively). Aberrometer autorefraction generated less cylinder deviation than the other methods (both P = .003). In the wavefront-optimized group (61 eyes, 36 patients), manifest refraction generated less deviation for sphere and SE than aberrometer autorefraction or corneal analyzer autorefraction (sphere: P = .005 and P = .009, respectively; SE: P = .005 and P = .002, respectively). Manifest refraction and aberrometer autorefraction cylinder generated similar deviation, while aberrometer autorefraction was less than corneal analyzer autorefraction (P = .041). Conclusions: Overall, manifest refraction was most accurate in generating postoperative emmetropia with both laser treatments; however, aberrometer autorefraction produced the least cylinder deviation for wavefront-guided treatment. Corneal analyzer autorefraction produced the least accurate results with both lasers. [Copyright &y& Elsevier]

Purpose: To validate the Ectasia Risk Score System for identifying patients at high risk for developing ectasia after laser in situ keratomileusis (LASIK).Design: Retrospective case-control study.Methods: Fifty eyes that developed ectasia and 50 control eyes with normal postoperative courses after LASIK were analyzed and compared using the previously described Ectasia Risk Score System, which assigns points in a weighted fashion to the following variables: topographic pattern, predicted residual stromal bed (RSB) thickness, age, preoperative corneal thickness (CT), and manifest refraction spherical equivalent (MRSE).Results: In this series, 46 (92%) eyes with ectasia were correctly classified as being at high risk for the development of ectasia, while three (6%) controls were incorrectly classified as being at high risk for ectasia (P < 1 x 10(-10)). Significantly more eyes were classified as high risk by the ectasia risk score than by traditional screening parameters relying on abnormal topography or RSB thickness less than 250 micro (92% vs 50%; P < .00001). There was no difference in the sensitivity or specificity of the Ectasia Risk Score System in the population from which it was derived and this independent population of ectasia cases and controls.Conclusions: The Ectasia Risk Score System is a valid and effective method for detecting eyes at risk for ectasia after LASIK and represents a significant improvement over previously utilized screening strategies. [ABSTRACT FROM AUTHOR]

Purpose: To compare the accuracy of intraocular lens (IOL) power calculations using 4 formulas: Hoffer Q, Holladay 1, Holladay 2, and SRK/T. Setting: Tertiary care center. Methods: This study was a retrospective comparative analysis. Immersion ultrasound biometry (axial length, anterior chamber depth, and lens thickness), manual keratometry, and postoperative manifest refraction were obtained in 643 eyes of consecutive patients who had routine uneventful cataract surgery with implantation of 1 of 2 IOLs using the same operative technique by the same surgeon. Biometric data were entered into each of the 4 IOL power calculation formulas, and the results were compared to the final manifest refraction. An optimized lens constant was used for each formula. Results were also stratified into groups of short, average, medium long, and very long axial length <22.0 mm, 22.0 to <24.5 mm, 24.5 to 26.0 mm, and >26.0 mm, respectively). Results: No formula was more accurate than the others as measured by mean absolute error. The formulas were also equally accurate when eyes were stratified by axial length. Conclusion: The 4 IOL power formulas provided equivalent refractive results in the entire group of eyes and in the subsets of axial lengths tested. [Copyright &y& Elsevier]

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. [ABSTRACT FROM AUTHOR]

Uneventful small-incision cataract surgery was performed in a 70-year-old man and a 62-year-old woman with implantation of a Tecnis Z9000 intraocular lens (IOL) (Pharmacia). No ocular pathology was present in the patients preoperatively. Unsolicited complaints of negative dysphotopsia were made postoperatively, and the symptoms have persisted for more than 1 year in both patients. Symptomatic negative dysphotopsia may be seen in association with the Z9000 IOL. [Copyright &y& Elsevier]

Transforming growth factor beta-induced (TGFBI) corneal dystrophies are a group of inherited progressive corneal diseases. Accumulation of transforming growth factor beta-induced protein (TGFBIp) is involved in the pathogenesis of TGFBI corneal dystrophies; however, the exact molecular mechanisms are not fully elucidated. In this review article, we summarize the current knowledge of TGFBI corneal dystrophies including clinical manifestations, epidemiology, most common and recently reported associated mutations for each disease, and treatment modalities. We review our current understanding of the molecular mechanisms of granular corneal dystrophy type 2 (GCD2) and studies of other TGFBI corneal dystrophies. In GCD2 corneal fibroblasts, alterations of morphological characteristics of corneal fibroblasts, increased susceptibility to intracellular oxidative stress, dysfunctional and fragmented mitochondria, defective autophagy, and alterations of cell cycle were observed. Other studies of mutated TGFBIp show changes in conformational structure, stability and proteolytic properties in lattice and granular corneal dystrophies. Future research should be directed toward elucidation of the biochemical mechanism of deposit formation, the relationship between the mutated TGFBIp and the other materials in the extracellular matrix, and the development of gene therapy and pharmaceutical agents. [ABSTRACT FROM AUTHOR]

PURPOSE: To report sight-threatening complications following extensive bulbar conjunctival resection and postoperative mitomycin C therapy for cosmetic eyewhitening in the United States. DESIGN: Retrospective noncomparative case series. METHODS: Multicenter report of 9 patients referred for evaluation and management of complications following bilateral cosmetic eye whitening. RESULTS: Seventeen eyes of 9 patients underwent cosmetic eye-whitening performed between 2 and 48 months prior to referral to one of the centers. Sixteen of the 17 eyes had persistent conjunctival epithelial defects, with 10 eyes requiring amniotic membrane grafting to facilitate re-epithelialization. Four eyes of 2 patients developed limbal stem cell compromise confirmed with in vivo confocal laser scanning microscopy. One patient developed infectious scleritis and diplopia resulting from Tenon capsule scarring. Another patient developed scleral necrosis, secondary infectious scleritis, and infectious endophthalmitis. This patient subsequently developed noninfectious scleritis that required 3-drug-regimen immunosuppression. CONCLUSION: Severe adverse effects can occur after extensive cosmetic conjunctival resection followed by topical mitomycin C application. Patients and physicians should be aware of the potential sight-threatening complications associated with this eye-whitening procedure. [ABSTRACT FROM AUTHOR]

Objective: To determine whether the 10-year success rate of penetrating keratoplasty for corneal endothelial disorders is associated with donor age. Design: Multicenter, prospective, double-masked clinical trial. Participants: A total of 1090 participants undergoing penetrating keratoplasty at 80 sites for Fuchs' dystrophy (62%), pseudophakic/aphakic corneal edema (34%), or another corneal endothelial disorder (4%) and followed for up to 12 years. Methods: Forty-three eye banks provided corneas from donors aged 12 to 75 years, using a randomized approach to assign donor corneas to study participants without respect to recipient factors. Surgery and postoperative care were performed according to the surgeons' usual routines. Main Outcome Measures: Graft failure defined as a regraft or, in the absence of a regraft, a cloudy cornea that was sufficiently opaque to compromise vision for 3 consecutive months. Results: In the primary analysis, the 10-year success rate was 77% for 707 corneas from donors aged 12 to 65 years compared with 71% for 383 donors aged 66 to 75 years (difference, +6%; 95% confidence interval, −1 to +12; P = 0.11). When analyzed as a continuous variable, higher donor age was associated with lower graft success beyond the first 5 years (P < 0.001). Exploring this association further, we observed that the 10-year success rate was relatively constant for donors aged 34 to 71 years (75%). The success rate was higher for 80 donors aged 12 to 33 years (96%) and lower for 130 donors aged 72 to 75 years (62%). The relative decrease in the success rate with donor ages 72 to 75 years was not observed until after year 6. Conclusions: Although the primary analysis did not show a significant difference in 10-year success rates comparing donor ages 12 to 65 years and 66 to 75 years, there was evidence of a donor age effect at the extremes of the age range. Because we observed a fairly constant 10-year success rate for donors aged 34 to 71 years, which account for approximately 75% of corneas in the United States available for transplant, the Cornea Donor Study results indicate that donor age is not an important factor in most penetrating keratoplasties for endothelial disease. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. [Copyright &y& Elsevier]

Abstract: Corneal collagen crosslinking with riboflavin photosensitization and ultraviolet irradiation is a novel approach to limiting the progression of keratoconus in patients by increasing the elastic modulus of the degenerate cornea. Beneficial reductions in corneal steepness and aberrations after crosslinking also frequently occur. In a previous study, we described a computational modeling approach to simulating topographic progression in keratoconus and regression of disease with corneal collagen crosslinking. In the current study, this model has been expanded and applied to the inverse problem of estimating longitudinal time-dependent changes in the corneal elastic modulus after crosslinking using in vivo measurements from 16 human eyes. Topography measured before crosslinking was used to construct a patient-specific finite element model with assumed hyperelastic properties. Then the properties of the cornea were altered using an inverse optimization method to minimize the difference between the model-predicted and in vivo corneal shape after crosslinking. Effects of assumptions regarding sclera-to-cornea elastic modulus ratio and spatial attenuation of treatment effect due to ultraviolet beam characteristics on the predicted change in elastic modulus were also investigated. Corneal property changes computed by inverse finite element analysis provided excellent geometric agreement with clinical topography measurements in patient eyes post-crosslinking. Over all post-treatment time points, the estimated increase in corneal elastic modulus was 110.8 ± 48.1%, and slightly less stiffening was required to produce the same amount of corneal topographic regression of disease when the sclera-to-cornea modulus ratio was increased. Including the effect of beam attenuation resulted in greater estimates of stiffening in the anterior cornea. Corneal shape responses to crosslinking varied considerably and emphasize the importance of a patient-specific approach. [Copyright &y& Elsevier]

Objective: To study the epidemiology, clinical observations, and microbiologic characteristics of fungal keratitis at tertiary eye care centers in the United States. Design: Retrospective multicenter case series. Participants: Fungal keratitis cases presenting to participating tertiary eye care centers. Methods: Charts were reviewed for all fungal keratitis cases confirmed by culture, histology, or confocal microscopy between January 1, 2001, and December 31, 2007, at 11 tertiary clinical sites in the United States. Main Outcome Measures: Frequency of potential predisposing factors and associations between these factors and fungal species. Results: A total of 733 cases of fungal keratitis were identified. Most cases were confirmed by culture from corneal scraping (n = 693) or biopsies (n = 19); 16 cases were diagnosed by microscopic examination of corneal scraping alone; and 5 cases were diagnosed by confocal microscopy alone. Some 268 of 733 cases (37%) were associated with refractive contact lens wear, 180 of 733 cases (25%) were associated with ocular trauma, and 209 of 733 cases (29%) were associated with ocular surface disease. No predisposing factor was identified in 76 cases (10%). Filamentous fungi were identified in 141 of 180 ocular trauma cases (78%) and in 231 of 268 refractive contact lens-associated cases (86%). Yeast was the causative organism in 111 of 209 cases (53%) associated with ocular surface disease. Yeast accounted for few cases of fungal keratitis associated with refractive contact-lens wear (20 cases), therapeutic contact-lens wear (11 cases), or ocular trauma (21 cases). Surgical intervention was undertaken in 26% of cases and was most frequently performed for fungal keratitis associated with ocular surface disease (44%). Surgical intervention was more likely in cases associated with filamentous fungi (P = 0.03). Among contact lens wearers, delay in diagnosis of 2 or more weeks increased the likelihood of surgery (age-adjusted odds ratio = 2.2; 95% confidence interval, 1.2–4.2). Conclusions: Trauma, contact lens wear, and ocular surface disease predispose patients to developing fungal keratitis. Filamentous fungi are most frequently the causative organism for fungal keratitis associated with trauma or contact lens wear, whereas yeast is most frequently the causative organism in patients with ocular surface disease. Delay in diagnosis increases the likelihood of surgical intervention for contact lens-associated fungal keratitis. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. [Copyright &y& Elsevier]