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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

Purpose To report the outcome of unilateral small incision lenticule extraction (SMILE) in a patient with granular corneal dystrophy type 2 (GCD2). Methods Slit-lamp photography and Fourier domain optical coherence tomography were used to document the clinical course and appearance of the corneas in a patient with genetically determined GCD2 who underwent unilateral SMILE in the right eye. Results Slit-lamp examination of a 23-year-old woman revealed 2 faint opacities at the surgical interface approximately 2 months after the SMILE procedure had been performed on her right eye. Nine and 3 typical GCD2 deposits located immediately beneath the Bowman layer were observed in the right and left corneas, respectively. Over time, the deposits at the interface increased in size, density, and number in the right eye. Fourier domain optical coherence tomography performed 33 months after the SMILE procedure revealed deposits at the SMILE interface that were distinct from those located immediately beneath the Bowman layer. The severity of disease exacerbation was less in this patient than what is typically observed in others who have undergone laser-assisted in situ keratomileusis or photorefractive keratectomy. Conclusions SMILE is contraindicated in patients with GCD2, as are other corneal refractive surgical procedures. This case highlights the importance of genetic testing before the performance of refractive corneal procedures-especially for patients with corneal opacities on preoperative slit-lamp examination or a family history of corneal disease compatible with that of a corneal dystrophy.

To evaluate the effect of riboflavin-ultraviolet (UV)-A corneal crosslinking (CXL) without epithelial removal on ectatic corneal disease.Woolfson Eye Institute, Atlanta, Georgia, USA.Prospective observational study.Patients were treated with a new riboflavin formulation without epithelial removal, then exposed to UV light (365 nm) at 4 mW/cmFive 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.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.

Purpose To report cases of necrotizing scleritis, a sight-threatening complication that can result from cosmetic conjunctivectomy procedures. Design Retrospective case series. Methods The medical records of consecutive patients who underwent eye-whitening conjunctivectomy with mitoycin C (MMC) treatment performed by 1 surgeon in South Korea and were referred to the authors' clinic between January 2011 and December 2015 were reviewed. The patients in whom findings of necrotizing scleritis with active inflammation were detected in an avascular area of previous conjunctivectomy were included. Results Of a total of 231 patients who had received cosmetic eye whitening, 4 patients who met the inclusion criteria were identified. The average length of time from cosmetic eye surgery to a diagnosis of necrotizing scleritis was 51 months and all patients had unilateral findings of necrotizing scleritis. There was no underlying systemic autoimmunity or infectious etiology in all cases. Three of these 4 patients were treated with a conjunctival flap; however, all 4 received systemic anti-inflammatory treatment with oral corticosteroids. The mean follow-up duration of the patients was 22.75 months. Conclusions Necrotizing scleritis is a severe complication that can arise after cosmetic eye-whitening conjunctivectomy with MMC. Because of the large area of the ocular surface that is treated in eye-whitening with MMC, the necrotizing scleritis that can ensue may be more extensive and severe than the surgically induced necrotizing scleritis following other periocular surgeries such as pterygium removal. Proper anti-inflammatory treatment and surgical intervention should be required for management of this complication.

To evaluate the effect on donor rim cultures and postoperative infections of doubling the povidone-iodine exposure time during corneal tissue recovery before its use in keratoplasty.Consecutive donor cornea recoveries were evaluated for positive donor corneal rim cultures and postoperative infections before and after a protocol change of doubling the exposure time of povidone-iodine during donor preparation.In 631 consecutive cornea donor recoveries, 18 (2.9%) had positive fungal rim cultures and 41 (6.5%) had positive bacterial rim cultures. Three (0.48%) developed postoperative fungal infections, and no bacterial infections occurred. After doubling the povidone-iodine exposure time during the recovery process, 725 consecutive corneas were reviewed. Four (0.6%) had positive fungal rim cultures, and 29 (4.0%) had positive bacterial rim cultures. No postoperative fungal or bacterial infections occurred. No noticeable increase in epithelial toxicity developed between the 2 groups.Increasing the povidone-iodine exposure time during the donor cornea recovery process decreased the rate of positive donor corneal rim fungal cultures (P = 0.001), positive donor corneal rim bacterial cultures (P = 0.04), and postoperative fungal infections (P = 0.06).

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: 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 three 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% CI 2.5% to 5.3%). Younger recipient age was associated with graft rejection [p0.01). 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=0.03). 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.

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.

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.

Purpose To analyze current practice patterns in the prevention and treatment of corneal graft rejection for both penetrating keratoplasty (PK) and endothelial keratoplasty (EK) and to compare these patterns with previously reported practices. Methods In 2011, an electronic survey was sent to 670 members of the Cornea Society worldwide addressing the routine postoperative management of corneal transplants at different time points, treatment of various manifestations of corneal graft rejection, and preferred surgical techniques. Results A total of 204 of 670 surveys (30%) were returned and evaluated. All respondents used topical corticosteroids for routine postoperative management and treatment of endothelial graft rejection. Prednisolone was the topical steroid of choice in all clinical scenarios, similar to previous surveys from 1989 to 2004. Use of subconjunctival and systemic steroids increased for many scenarios of probable and definite graft rejection. Routine use of prednisolone decreased by approximately 10% from previous surveys, whereas difluprednate was used in 13% of high-risk eyes during the first 6 months. Dexamethasone, fluorometholone, and loteprednol use remained stable. Adjunctive topical cyclosporine use increased significantly for PK and EK. EK was the preferred technique for endothelial dysfunction, whereas PK and deep anterior lamellar keratoplasty were both used for keratoconus and anterior scars. Most respondents (75%) felt that graft rejection occurs more frequently after PK than after EK. Conclusions Prednisolone remains the treatment of choice for management and treatment of graft rejection; however, since the introduction of difluprednate, its use has declined slightly since the introduction of difluprednate. Despite perceived differences in rejection rates, there were no differences in prophylactic steroid treatment for PK and EK.

PURPOSE: To determine glare-induced change during visual acuity testing in patients with and without cataract using the controlled point source light-emitting diode (LED) glare tester (EpiGlare Tester; Epico, LLC, Columbus, OH), a new medical device for identification of glare disability. METHODS: This prospective, multicenter study enrolled 40 patients (80 eyes with cataracts) and 49 control subjects (98 eyes without cataracts). Corrected distance visual acuity (CDVA) was measured with and without glare using the EpiGlare Tester as a glare source. Functional visual ability was evaluated using driving and glare subscales from the Refractive Status Vision Profile questionnaire. The primary efficacy measure was change in CDVA measurement with and without glare in patients with senile cataract compared to participants without cataract. Secondary efficacy measures included correlation of the CDVA change caused by functional glare disability and subjective patient and investigator assessments. RESULTS: CDVA reduction was greater for patients with cataract, with a mean reduction of −0.49 ± 0.3 logMAR, than for participants without cataracts at −0.13 ± 0.2 logMAR ( P < .001). This equates to a 5-line Snellen reduction (0.49 logMAR) in patients with cataracts and a 1-line reduction (−0.13 logMAR) in patients without cataracts. Among patients with cataracts, 83% stated the device accurately represented the difficulty experienced while driving at night ( P < .001); among participants without cataracts, 71% reported being minimally affected by glare from the device ( P = .003). CONCLUSIONS: A new controlled point source LED glare tester demonstrated the adverse effect on visual acuity due to glare in patients with cataract, accurately simulated night driving glare issues for patients with cataracts, and was rated as easy to use and useful by investigators. [ J Refract Surg. 2015;31(3):196–201.]

Recent (2012) grave but rare outbreaks of fungal meningitis and endophthalmitis associated with drugs contaminated with select environmental moulds (Exserohilum and Fusarium, respectively) have exacerbated mycology concerns for formulation, good laboratory practices (GLP), and use of the final drug product. Intensified investigations (2013-2015) by the Food and Drug Administration (FDA) that included added responsibilities for specialty compounding laboratories have prompted at least nine voluntary mould-related drug recalls during 2014-2015. Both primary manufactures (five recalls, two companies) and secondary-processing compound laboratories (at least eight recalls, six companies) and near 0.8 million units were involved. These constituted minor fractions of recalled drug products in an estimated 2500 recalls among other causes during this time period. Recalls of similar drugs in 2016 were indirectly related to fungi. None of the mould-related- drug-recall episodes during 2014-2016 have been identified with fungal disease outbreaks. The recalls included drugs in short supply worldwide such as injectable sodium chloride- and related saline solutions as well as ocular formulations. Insufficient environmental monitoring and GLP compliance, particularly for aseptic processing of non-preserved formulations, appeared to be underlying factors in the fungal contaminations. Observations of mould growth in drugs during their processing should be accurately recorded and investigated; cryptic listings under "particulate" designations should be avoided. Confirmed identifications for chronic contaminants are recommended. Heat-tolerant moulds with resistant morphotypes are prime concerns.

To assess changes in Ocular Response Analyzer (ORA) waveforms after UVA/riboflavin corneal collagen cross-linking (CXL) using investigator-derived and manufacturer-supplied morphometric variables in patients with keratoconus (KC) and postrefractive surgery ectasia.Prospective randomized trial of a standard epithelium-off CXL protocol.Patients with progressive KC (24 eyes of 21 patients) or postrefractive surgery ectasia (27 eyes of 23 patients) were enrolled.Replicate ORA measurements were obtained before and 3 months after CXL. Pretreatment and posttreatment waveform variables were analyzed for differences by paired Student t tests using measurements with the highest waveform scores.Corneal hysteresis, corneal resistance factor, 37-s generation manufacturer-supplied ORA variables, and 15 investigator-derived ORA variables.No variables were significantly different 3 months after CXL in the KC group, and no manufacturer-supplied variables changed significantly in the postrefractive surgery ectasia group. Four custom variables (ApplanationOnsetTime, P1P2avg, Impulse, and Pmax) increased by small but statistically significant margins after CXL in the postrefractive surgery ectasia group.Changes in a small subset of investigator-derived variables suggested an increase in corneal bending resistance after CXL. However, the magnitudes of these changes were low and not commensurate with the degree of clinical improvement or prior computational estimates of corneal stiffening in the same cohort over the same period. Available air-puff-derived measures of the corneal deformation response underestimate the biomechanical changes produced by CXL.

� 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. (Am J Ophthalmol 2014;158:967‐973. Published by Elsevier Inc.)

PURPOSE: To evaluate changes in corneal epithelial and stromal thickness after corneal collagen cross-linking (CXL) in eyes with keratoconus and postoperative corneal ectasia using spectral-domain optical coherence tomography (SD-OCT). METHODS: Anterior segment SD-OCT (RTVue-100; Optovue, Inc., Fremont, CA) was used to compare regional corneal epithelial and stromal thickness in eyes with keratoconus and ectasia before CXL and 1 and 3 months after CXL. The anterior surface of the cornea, epithelium–Bowman’s layer interface, and posterior reflective surface were used as anatomical landmarks to measure epithelial and stromal thickness, respectively. Regional thickness was assessed centrally and at 21 points 0.5 mm apart across the central 6 mm of the corneal vertex in the horizontal and vertical meridians. RESULTS: Thirty-one eyes from 30 patients were evaluated, including 17 eyes (17 patients) with keratoconus and 14 eyes (13 patients) with ectasia. Preoperatively, a highly irregular epithelial thickness profile and distribution was observed in both groups. After CXL, epithelial thickness was significantly thinner 2.5 and 2 mm below and 1.5 mm above the corneal apex (49.26 ± 5.69 μ m; range: 43 to 62 μ m), and 2.5 and 1 mm nasal and 2 mm temporal to the corneal apex (46.66 ± 4.53 μ m; range: 39 to 57 μ m) compared to preoperative values ( P < .05 for all measurements). Epithelial thickness standard deviations were significantly lower (by 3 to 6 μ m) 3 months after CXL, compared to ranges before CXL in both the vertical and horizontal meridians for keratoconus and ectasia ( P = .048). No significant differences were found between epithelial remodeling in keratoconus and corneal ectasia ( P = .98). No significant or consistent stromal changes were found for either group. CONCLUSIONS: Significant epithelial remodeling occurs after CXL in eyes with keratoconus and corneal ectasia, creating a similar, more regularized thickness profile in all meridians in the early postoperative period. This pattern of remodeling may facilitate interpretation of corneal curvature and thickness changes after CXL and may be related to visual acuity after CXL. [ J Refract Surg. 2014;30(2):122–127.]

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 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.

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.

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.

Corneal collagen cross-linking (CXL) using the classical Dresden protocol has the potential to create complications, including endothelial cell damage, persistent epithelial defects, scarring, and infectious keratitis. Most of these complications are due to epithelial removal, which can be avoided by newer techniques that allow penetration of riboflavin through an intact epithelium.

Corneal cross linking (CXL) has significant supporting evidence suggesting that it stabilizes keratoconus (KC) and increases corneal rigidity. Randomized clinical trials demonstrating this in a statistically significant manner would still be welcomed however.

Purpose To assess the relationship between donor and recipient factors and corneal allograft rejection in eyes that underwent penetrating keratoplasty in the Cornea Donor Study. Methods Overall, 1090 subjects undergoing corneal transplantation for a moderate risk condition (principally Fuchs dystrophy or pseudophakic corneal edema) were followed for up to 5 years. Associations of baseline recipient and donor factors with the occurrence of a probable or definite rejection event were assessed in univariate and multivariate proportional hazards models. Results Eyes with pseudophakic or aphakic corneal edema (n = 369) were more likely to experience a rejection event than eyes with Fuchs dystrophy (n = 676) [34% ± 6% vs. 22% ± 4%; hazard ratio = 1.56; 95% confidence interval (CI), 1.21-2.03]. Among eyes with Fuchs dystrophy, a higher probability of a rejection event was observed in phakic posttransplant eyes compared with those that underwent cataract extraction with or without intraocular lens implantation during penetrating keratoplasty (29% vs. 19%; hazard ratio = 0.54; 95% CI, 0.36-0.82). Female recipients had a higher probability of a rejection event than male recipients (29% vs. 21%; hazard ratio = 1.42; 95% CI, 1.08-1.87) after controlling for the effect of preoperative diagnosis and lens status. Donor age and donor recipient ABO compatibility were not associated with rejection. Conclusions There was a substantially higher graft rejection rate in eyes with pseudophakic or aphakic corneal edema compared to that in eyes with Fuchs dystrophy. Female recipients were more likely to have a rejection event than male recipients. Graft rejection was not associated with donor age.

Objective Fungal keratitis is a serious ocular infection that is considered to be rare among contact lens wearers. The recent Fusarium keratitis outbreak raised questions regarding the background rate of Fusarium -related keratitis and other fungal keratitis in this population. Design Retrospective, multicenter case series. Participants Six hundred ninety-five cases of fungal keratitis cases who presented to 1 of 10 tertiary medical centers from 2001 to 2007. Methods Ten tertiary care centers in the United States performed a retrospective review of culture-positive fungal keratitis cases at their centers between January 2001 and December 2007. Cases were identified using microbiology, pathology, and/or confocal microscopy records. Information was collected on contact lens status, method of diagnosis, and organism(s) identified. The quarterly number of cases by contact lens status was calculated and Poisson regression was used to evaluate presence of trends. The Johns Hopkins Medicine Institutional Review Board (IRB) and the IRBs at each participating center approved the research. Main Outcome Measures Quarterly number of fungal keratitis cases and fungal species. Results We identified 695 fungal keratitis cases; 283 involved the use of contact lenses. The quarterly number of Fusarium cases increased among contact lens wearers (CLWs) during the period that ReNu with MoistureLoc (Bausch & Lomb, Rochester, NY) was on the market, but returned to prior levels after withdrawal of the product from the market. The quarterly frequency of other filamentous fungi cases showed a statistically significant increase among CLWs comparing October 2004 through June 2006 with July 2006 through December 2007 with January 2001 through September 2004 ( P Conclusions The quarterly number of Fusarium fungal keratitis cases among CLWs returned to pre-Renu with Moistureloc levels after removal of the product from the market. However, the number of other filamentous fungal keratitis cases, although small, seems to have increased among refractive CLWs. Reasons for these apparent increases are unclear. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.

To study the effect of flap thickness on visual acuity and refractive outcomes after laser in situ keratomileusis (LASIK) using 2 blade types with a mechanical microkeratome.Emory Vision, Atlanta, Georgia, USA.This retrospective analysis was of LASIK cases performed between January 2005 and June 2006 using an Amadeus I microkeratome and an ML7090 CLB blade (blade A) or a Surepass blade (blade B). Outcomes analyzed included flap thickness, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), the enhancement rate, and surgical complications 3 months postoperatively.Two hundred sixty-three eyes of 153 patients were analyzed; blade A was used in 158 eyes and blade B, in 105 eyes. The mean flap thickness was significantly thinner with blade A than with blade B (107 microm +/- 12 [SD] versus 130 +/- 20 microm) (P.0001). There was no overall correlation with either blade between flap thickness and UDVA, CDVA, or MRSE (all r0.2). At 3 months, there was no statistically significant difference in UDVA, CDVA, or MRSE between the 2 blade groups at 3 months (all P.10), and there was no difference in the complication rates.Flap thickness did not affect visual or refractive outcomes with a mechanical microkeratome with either blade type.

Aim To evaluate the use of Fourier-domain optical coherence tomography (FD-OCT) in the selection and planning of surgical procedures to treat GCD2 (granular corneal dystrophy type 2). Methods An RTVue-100 FD-OCT (Optovue, Fremont, California) was used to determine the size, depth and location of deposits in six patients with homozygous or heterozygous GCD2. Results The RTVue-100 FD-OCT revealed the depth of the deposits quite precisely, allowing the determination of the appropriate depth of PTK (phototherapeutic keratectomy) and the appropriate selection of lamellar versus penetrating keratoplasty as the procedure of choice. In each case, visually significant opacities were adequately removed or would be removed. Conclusion FD-OCT provides useful information for the selection and planning of surgical procedures to remove corneal opacities in patients with GCD2.

To analyze the changes in higher-order aberrations (HOAs) that occur after wavefront-optimized photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK).Emory Eye Center and Emory Vision, Atlanta, Georgia, USA.This retrospective analysis comprised eyes that had PRK or LASIK from June 2004 through October 2005. Postoperative outcome measures included 3-month uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), manifest refraction spherical equivalent (MRSE), changes in the root mean square (RMS) and grouped coefficient HOAs (microns) measured with a corneal analyzer, and subjective assessment of visual aberrations.One hundred consecutive eyes of 54 patients had PRK, and 100 contemporaneous consecutive eyes of 71 patients had LASIK. The PRK and LASIK populations were similar in general demographics, preoperative HOAs, and postoperative UCVA and BSCVA. The mean MRSE was slightly hyperopic after PRK (mean +0.11 diopters [D]) and slightly myopic after LASIK (mean -0.19 D) (P.0001). There were no statistically significant changes in RMS or grouped coefficient HOA values after PRK or LASIK, nor were there significant differences in postoperative RMS or grouped coefficient HOA values between PRK and LASIK. One percent of PRK and LASIK patients reported a subjective increase in postoperative visual aberrations; 5% reported a subjective improvement postoperatively.Wavefront-optimized excimer laser surgery did not induce significant HOAs after PRK or LASIK. The 2 techniques were equally efficacious and had equivalent postoperative HOA profiles.

Purpose The purpose of this study was to report the confocal microscopic, characteristics of epithelial downgrowth and the clinical utility of serial confocal examinations in the management of epithelial downgrowth. Methods Retrospective case review of 3 eyes from 3 patients that developed epithelial downgrowth after ocular surgery with penetrating ocular trauma and literature review. Results Two cases developed epithelial downgrowth and a retrocorneal membrane after both penetrating ocular trauma and multiple intraocular surgeries. A third case developed epithelial downgrowth presenting as a membranous growth noted on the endothelial surface after multiple intraocular surgeries. In all cases, confocal microscopy revealed round, hyperreflective nuclei characteristic of epithelial cells at the level of the endothelium, and in 2 cases, the diagnosis was confirmed by histopathologic evaluation. In cases 2 and 3, confocal microscopic analysis proved useful in following epithelial regression after 5-fluorouracil injection, and in case 3, confocal microscopy proved to be potentially more sensitive in identifying residual epithelial downgrowth than routine light microscopy. Conclusions Confocal microscopy can definitively diagnose epithelial downgrowth occurring after previous ocular surgery or ocular trauma and may prove useful for following downgrowth after intervention.

PURPOSE: To report the clinical features and outcome of eyes with flap buttonhole during LASIK. METHODS: A retrospective review was performed to identify eyes that developed flap buttonhole during Hansatome microkeratome translation. Pre-, intra-, and postoperative data were obtained to identify factors predictive of buttonhole. RESULTS: Five patients with buttonhole were identified from June 2001 through September 2002 (5 [0.06%] eyes of 7672 primary LASIK procedures). Mean patient age was 49.2±11.3 years (range: 37 to 66 years). Mean preoperative spherical equivalent refraction was -4.92±2.90 diopters (D) (range: -2.25 to -9.50 D). Mean keratometry was 45.59±1.15 D (range: 43.90 to 47.60 D). All 5 flap buttonholes occurred in the second of 2 consecutively treated eyes (P=.03). Buttonhole occurred in 2 (0.26%) of 778 eyes where the 160-µm microkeratome plate was used, and 3 (0.06%) of 4350 eyes where the 180-µm plate was used (P=.16). Two eyes received laser ablation at the time of buttonhole formation. In the untreated cases, the buttonhole flap itself caused a myopic spherical change of -0.50 D and 0.70 D of astigmatism. One of 5 eyes lost 2 lines of best spectacle-corrected visual acuity; this eye received laser ablation immediately after buttonhole formation. CONCLUSIONS: Buttonholes are significantly more likely to occur in the second of two consecutively treated eyes. A new blade for the second eye when the flap in the first eye appears to be thin should be considered. Caution should be exercised when considering laser ablation immediately following buttonhole formation. [J Refract Surg. 2007;23:472-476.]

To evaluate the clinical implementation of guidelines for the treatment of dysfunctional tear syndrome (DTS) developed by the International Task Force (ITF) of dry eye disease experts.Nine physicians implemented the ITF guidelines for 3 months. Newly diagnosed patients with DTS rated their ocular symptoms and were clinically examined. Using the guidelines, physicians determined the DTS severity level (0-4, where 4 is most severe) and made their therapeutic choices.Of 183 patients enrolled (mean age, 65.1 years; range, 25-91 years), 67% presented without lid margin disease, and 68% had no apparent ocular surface inflammation. Symptoms were significantly more severe in patients with altered tear distribution or evident inflammation (P0.05). Most patients diagnosed at severity level 1 did not have lid margin disease (56/61, 92%), and inflammation was not apparent (53/58, 91%); 43% of severity level 1 patients (27/63) were treated at level 2 (therapeutic choices include unpreserved tears or topical cyclosporine). Most patients presenting with inflammation were diagnosed at severity level 2 (74%, 32/43). More than 9 in 10 severity level 2 patients were treated at level 2 (100/106; 94%). Physicians reported that 96% of their treatment recommendations were consistent with management they would have recommended if they had not consulted the ITF guidelines. They spent an average of 4.5 minutes per patient applying the guidelines.Implementation of the ITF guidelines was simple and not time consuming. Many practitioners chose to treat patients diagnosed at severity level 1 with treatments at level 2 that include unpreserved tears and topical cyclosporine.

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.

Two patients developed corneal ectasia after photorefractive keratectomy (PRK). Case 1 had evidence of early keratoconus preoperatively, with manifest refractions of -4.00 +2.50 x 160 (20/20) in the right eye and -7.00 +3.00 x 180 (20/30) in the left eye; thin corneas (472 microm and 441 microm, respectively); and inferior paracentral steepening in the right eye and central steepening in the left eye on topography. Case 2 had manifest refractions of -8.50 +3.75 x 123 (20/20(-2)) in the right eye and -9.25 +4.00 x 077 (20/20(-1)) in the left eye; corneal thickness of 509 microm and 508 microm, respectively; and symmetric bow-tie patterns in both eyes on topography. Case 2 had a family history suspicious for keratoconus, with a sibling who had bilateral corneal transplantation at a young age. Both patients developed bilateral corneal ectasia after PRK.

To study the relationship between intraocular pressure (IOP) readings after LASIK and the amount of refractive correction.Retrospective noninterventional case series.Patients receiving primary LASIK for myopia and myopic astigmatism.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.Best-fit curve relating change in measured IOP to refractive change.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, P0.001). Extrapolation of the data to a theoretical correction of zero diopters revealed a decrease of 1.36 mmHg (95% CI, 1.20-1.51, P0.001), suggesting a component of measured IOP change that is independent of laser ablation.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.

Retinal surgery can induce significant refractive errors. These errors include spherical changes caused by alterations in axial length after scleral buckle placement, astigmatic changes induced by a scleral buckle or pars plana vitrectomy, and focal alterations in corneal curvature that can significantly limit postoperative visual acuity. The adjunctive use of silicone oil can impose alterations directly, by the oil's interaction with the other refractive elements of the eye, and indirectly, through its effects on intraocular lens power calculations for subsequent cataract surgery.

To report a series of cases with asymmetric keratoconus attributed to eye rubbing, discuss its pathogenesis, and review the literature.Case reports and literature review.A careful history obtained from 5 patients with asymmetric keratoconus revealed habitual eye rubbing of the more severely affected eye.Trauma, such as occurs with habitual eye rubbing, plays a role in the pathogenesis of keratoconus.

Objective: To report the reactivation of presumed adenoviral keratitis after laser in situ keratomileusis (LASIK). Methods: Case report and literature review. Results: The patient underwent uneventful LASIK more than 5 years after an episode of adenoviral keratitis that left subepithelial corneal scarring. Three months after LASIK, new subepithelial infiltrates appeared in the right eye. These lesions resolved without sequelae during treatment with topical steroids. The patient's uncorrected and best-corrected visual acuity returned to her postoperative baseline. Conclusion: LASIK may cause delayed exacerbation of subepithelial infiltrates caused by adenoviral keratitis. However, good visual outcomes can be achieved with recognition of this reactivation and treatment with topical corticosteroids.

Objective To determine the long-term outcome of surgery for congenital glaucoma in infants and children with Peters' anomaly. Design Retrospective review of a consecutive interventional case series. Setting An urban academic tertiary referral institution. Participants Thirty-four eyes of 19 children are subjects of this report. Included are all children 12 years of age or younger with Peters' anomaly who underwent surgery for primary congenital glaucoma between January 1971 and December 1992 and completed a minimum of 3 years of follow-up from the date of the first glaucoma surgery. Intervention The surgical procedures performed were trabeculectomy, trabeculotomy, goniotomy, Molteno shunt implantation, cyclodialysis, and cyclocryotherapy. Main outcome measures Primary outcome measures were intraocular pressure (IOP) control and final postoperative visual acuity. Intraocular pressure control was defined as complete success (IOP≤21 mmHg without antiglaucoma medication), qualified success (IOP≤21 mmHg with antiglaucoma mediation), or failure (IOP>21 mmHg with or without antiglaucoma medication, inoperable retinal detachment, phthisis, or chronic hypotony, defined as an IOP of ≤6 mmHg). Results A total of 126 glaucoma procedures were performed on 34 eyes of 19 patients. The median age at time of first glaucoma surgery was 2.1 months (range, 2 days to 8.5 years). The median follow-up was 11.0 years (range, 3.2 to 22.8 years) from the time of first glaucoma surgery. Intraocular pressure control with or without antiglaucoma medication was achieved in 11 eyes (32%) after 1 or more surgical procedures. Major postoperative complications included graft failure in 26 eyes (76%), cataract in 6 eyes (18%), inoperable retinal detachment with phthisis in 12 eyes (35%), and phthisis alone in 6 eyes (18%). Final vision was 20/200 or better in 3 eyes (9%), 20/400 to hand motion in 12 eyes (35%), light perception in 7 eyes (21%), and no light perception in 12 eyes (35%). Conclusions Glaucoma surgery, combined with medical therapy, may result in adequate, long-term IOP control in 32% of eyes with glaucoma associated with Peters' anomaly. Visual results are poor due to uncontrolled glaucoma, amblyopia, neurologic impairment, and other anterior and posterior segment anomalies that may accompany Peters' anomaly. Postoperative complications, including graft failure, cataract, inoperable retinal detachment, and phthisis, also contribute to decreased visual acuity.

Visual aberrations such as glare and halo have been well documented after laser in-situ keratomileusis (LASIK). These are more likely in patients with higher refractive errors and large pupil diameters. We present a patient with good Snellen acuity but functional impairment by visual aberrations after LASIK. These symptoms resolved after an InterWave-guided LASIK multipass, multistage enhancement treatment to correct spherical aberrations.

To review cases of corneal ectasia after laser in situ keratomileusis (LASIK), identify preoperative risk factors, and evaluate methods and success rates of visual rehabilitation for these cases.Retrospective nonrandomized comparative trial.Ten eyes from seven patients identified as developing corneal ectasia after LASIK, 33 previously reported ectasia cases, and two control groups with uneventful LASIK and normal postoperative courses: 100 consecutive cases (first control group), and 100 consecutive cases with high myopia (8 diopters [D]) preoperatively (second control group).Retrospective review of preoperative and postoperative data for each case compared with that of previously reported cases and cases with uneventful postoperative courses.Preoperative refraction, topographic features, residual stromal bed thickness (RSB), time to the development of ectasia, number of enhancements, final best-corrected visual acuity (BCVA), and method of final correction.Length of follow-up averaged 23.4 months (range, 6-48 months) after LASIK. Mean time to the development of ectasia averaged 16.3 months (range, 1-45 months). Preoperative refraction averaged -8.69 D compared with -5.37 D for the first control group (P = 0.005). Preoperatively, 88% of ectasia cases met criteria for forme fruste keratoconus, compared with 2% of the first control group (P0.0000001) and 4% of the second control group (P = 0.0000001). Seven eyes (70%) had RSB250 microm, as did 16% of eyes in the first control group and 46% of the second control group. The mean RSB for ectasia cases (222.8 microm) was significantly less than that for the first control group (293.6 micro m, P = 0.0004) and the second control group (256.5 microm; P = 0.04). Seven eyes (70%) had enhancements. Only 10% of eyes lost more than one line of BCVA, and all patients eventually achieved corrected vision of 20/30 or better. One case required penetrating keratoplasty (10%), while all others required rigid gas-permeable contact lenses for correction.Significant risk factors for the development of ectasia after LASIK include high myopia, forme fruste keratoconus, and low RSB. All patients had at least one risk factor other than high myopia, and significant differences remained even when controlling for myopia. Multiple enhancements were common among affected cases, but their causative role remains unknown. We did not identify any patients who developed ectasia without recognizable preoperative risk factors.

OBJECTIVE: To evaluate a method of obtaining conjunctival cells that utilizes aspiration of the conjunctival surface. STUDY DESIGN: Eighteen eyes from 16 patients with epibulbar lesions underwent aspiration of the conjunctival surface using a tuberculin syringe without a needle. The aspirated cells were prepared by the cytocentrifuge or Millipore filter technique. The lesions were subsequently biopsied, and the cytologic and histologic diagnoses were compared. RESULTS: Diagnoses of the conjunctival lesions, in decreasing order of frequency, were conjunctival intraepithelial neoplasia (dysplasia, carcinoma in situ), squamous cell carcinoma, squamous metaplasia, nevus, lymphoma and inflammation. In this feasibility study, the cytologic diagnosis accurately correlated with the histologic diagnosis in most cases. There were two cases in which the cytologic diagnosis led to the correct histologic diagnosis. CONCLUSION: Aspiration cytology of the conjunctival surface is useful in obtaining diagnostic material and may be used as a guide to where a biopsy should be performed. Limitations include inadequate samples and lack of observer experience.

To report a case of Avellino corneal dystrophy that increased in severity 1 year after uncomplicated laser in situ keratomileusis (LASIK) for myopia.Avellino dystrophy was confirmed by polymerase chain reaction sequencing of DNA from the patient and her parents.Best spectacle-corrected visual acuity decreased from 20/20 to 20/30 12 to 20 months after LASIK owing to opacities that appeared centrally in the corneal stroma and the LASIK flap and remaining posterior stroma interface.LASIK is contraindicated in patients with Avellino corneal dystrophy because vision may be reduced by corneal opacities that appear in the interface of the flap and remaining posterior stroma postoperatively.

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. Trial Registration clinicaltrials.gov Identifier:NCT01537393

Purpose We constructed several mathematical models that predict endothelial cell density (ECD) for patients after penetrating keratoplasty (PK) for a moderate-risk condition (principally Fuchs' dystrophy or pseudophakic/aphakic corneal edema). Methods In a subset (n = 591) of Cornea Donor Study participants, postoperative ECD was determined by a central reading center. Various statistical models were considered to estimate the ECD trend longitudinally over 10 years of follow-up. A biexponential model with and without a logarithm transformation was fit using the Gauss-Newton nonlinear least squares algorithm. To account for correlated data, a log-polynomial model was fit using the restricted maximum likelihood method. A sensitivity analysis for the potential bias due to selective dropout was performed using Bayesian analysis techniques. Results The three models using a logarithm transformation yield similar trends, whereas the model without the transform predicts higher ECD values. The adjustment for selective dropout turns out to be negligible. However, this is possibly due to the relatively low rate of graft failure in this cohort (19% at 10 years). Fuchs' dystrophy and pseudophakic/aphakic corneal edema (PACE) patients had similar ECD decay curves, with the PACE group having slightly higher cell densities by 10 years. Conclusions Endothelial cell loss after PK can be modeled via a log-polynomial model, which accounts for the correlated data from repeated measures on the same subject. This model is not significantly affected by the selective dropout due to graft failure. Our findings warrant further study on how this may extend to ECD following endothelial keratoplasty.

Objective To study the safety and efficacy of simultaneous bilateral laser in situ keratomileusis (LASIK). Design Prospective randomized clinical trial. Participants Fourteen surgeons and 714 consecutive eyes of 357 patients who desired surgical correction of myopia ranging from −2.00 to −22.50 diopters. Intervention Patients were randomized to simultaneous or sequential bilateral LASIK. Main outcome measures Primary outcome measures were safety and efficacy. Procedure safety was assessed, for simultaneous and sequential groups, by comparison of intraoperative and postoperative complication rates and the percentage of eyes losing two or more lines of spectacle-corrected visual acuity. Procedure efficacy was assessed by comparison of the percentage of eyes with uncorrected visual acuity better than or equal to 20/20 and 20/40 and the percentage of eyes within ±0.50 and ±1.00 diopters of intended outcome. Results Three hundred seventy-eight eyes were enrolled in the simultaneous group, and 331 eyes were enrolled in the sequential group. Mean follow-up was 10 months (±4.2 months standard deviation; range, 2 weeks-22 months). There was no significant difference in intraoperative complication rate ( P = 0.55), loss of two or more lines of spectacle-corrected visual acuity ( P = 0.87), or percentage of eyes within ±0.50 diopters of intended correction ( P = 0.17) between simultaneous and sequential groups. Postoperative complications were not significantly different in the two groups except for the unexplained more frequent epithelial ingrowth in the simultaneous group (2.9%) than in the sequential group (0.6%). The adjusted odds ratio for epithelial ingrowth in the simultaneous group was 1.02 (95% confidence interval, 1.01–1.08). There was no increased likelihood of epithelial ingrowth in the second of two simultaneously treated eyes ( P = 0.95). Conclusion The outcomes and complications of performing bilateral simultaneous LASIK were not significantly different from those of sequential treatments, with the unexplained exception of more frequent epithelial ingrowth in the simultaneous group.

Objective To determine the incidence and severity of complications from laser in situ keratomileusis (LASIK) for the correction of myopia by experienced and inexperienced surgeons. Design Prospective, observational clinical study. Participants Fourteen surgeons and 1062 eyes of 574 myopic patients who desired surgical correction of myopia ranging from −2.00 to −22.50 diopters (D; mean, −7.57 D) and astigmatism no greater than 4.00 D participated in this study. Intervention Myopia was corrected with LASIK. Astigmatism was corrected with arcuate keratotomy at the same time as the initial procedure or subsequently. Main outcome measures Primary outcome measures were change in best spectacle-corrected visual acuity (BSCVA) and the incidence of complications. Results Eyes were followed for a mean of 9.5 months after their last surgical procedure (range, 2 weeks–21 months). Three hundred eighty-one eyes (36%) underwent 468 enhancement procedures 3 months or more after the initial treatment. There were 27 (2.1%) intraoperative and 40 (3.1%) postoperative complications. Laser ablation was not performed during the initial treatment of 17 (1.6%) eyes because of intraoperative complications. Seventy-four eyes gained 2 or more lines of BSCVA, while 50 eyes lost 2 or more lines of BSCVA. Only three eyes lost two or more lines of BSCVA to a level worse than 20/40. One eye with a flap buttonhole (BSCVA 20/50) also had an epiretinal membrane. The second eye (BSCVA 20/60) had a flap buttonhole that may have been related to a previous corneal transplant. The third eye (−22.50 D before surgery) had a rhegmatogenous retinal detachment develop, reducing BSCVA from 20/60 to 20/200. The incidence of intraoperative complications decreased from 3.1% during the first 3 months to 0.7% during the last 9 months of the study ( P = 0.02). Conclusions LASIK is acceptably safe for the correction of myopia. Although complications occur in approximately 5% of cases, these rarely lead to visual loss of more than two Snellen lines and postoperative acuity below 20/40. Flap buttonholes were more likely to cause loss of BSCVA than free or incomplete flaps ( P = 0.02); flap buttonholes may be more likely in eyes that have undergone previous surgery. Complication rates can be reduced as the surgical team gains experience.

Objective This study aimed to determine whether there is a true difference in predictability between single-zone and multizone laser in situ keratomileusis (LASIK) for the correction of low myopia or whether any difference in predictability is because of a need for separate clinical nomograms for the two treatments. Design A prospective, randomized, clinical trial. Participants Fourteen surgeons and 190 eyes of 95 patients with myopia who desired surgical correction of myopia ranging from −2.00 to −7.00 diopters (D) participated. Intervention Fellow eyes of patients with myopia undergoing bilateral simultaneous LASIK were randomized to single-zone and multizone ablation. Astigmatism was not corrected at the time of LASIK. Main outcome measures Predictability, postoperative videokeratography, and contrast sensitivity were assessed at 3 months after surgery. Results At 3 months, r 2 values relating laser setting to change in spherical equivalent refraction were 0.78 for single-zone and 0.76 for multizone ablation; mean outcome with respect to intended was −0.84 D (0.65 standard deviation [SD]) for single-zone and −0.62 D (0.78 SD) for multizone eyes ( P = 0.035). There was no relationship between single-zone and multizone ablation and the likelihood of asymmetric postoperative videokeratography ( P = 0.83). The only difference in contrast sensitivity was a significantly greater decrease in log contrast for multizone eyes at 12 cyc/deg under undilated conditions. Conclusions There is no true difference in predictability between single-zone and multizone LASIK for the correction of low myopia. Separate clinical nomograms for single-zone and multizone LASIK should eliminate the difference in predictability that was observed in this clinical trial.

Background Long-term treatment with antiviral agents has been shown to prevent recurrences of genital and orofacial herpes simplex virus (HSV) disease, but it is uncertain whether prophylactic treatment can prevent recurrences of ocular HSV disease. Methods We randomly assigned 703 immunocompetent patients who had had ocular HSV disease within the preceding year to receive 400 mg of acyclovir or placebo orally twice daily. The study outcomes were the rates of development of ocular or nonocular HSV disease during a 12-month treatment period and a 6-month observation period. Results The cumulative probability of a recurrence of any type of ocular HSV disease during the 12-month treatment period was 19 percent in the acyclovir group and 32 percent in the placebo group (P

Objective: The purpose of the study is to determine whether there is a higher incidence of complications in adult patients receiving corneas from pediatric donors compared to those receiving corneas from adult donors. Design: The design is a follow-up of two matched cohorts. Participants: The outcome of penetrating keratoplasty in 29 adult patients (age 20 years of age and older) receiving pediatric donor corneas (range, 0–5 years) was compared to that of 29 control patients matched for recipient age and diagnosis who received adult donor corneas (range, 40–70 years). Intervention: Chart review was performed. Main Outcome Measures: Graft rejection, postoperative keratometry, postoperative refractive cylinder, postoperative intraocular pressure, and graft failure due to rejection were measured. Results: One or more allograft reactions occurred in 11 (37.9%) of 29 patients who received pediatric donor corneas compared to 2 (6.9%) of 29 patients who received adult donor corneas ( P = 0.005, chi-square). There were a total of 20 rejection episodes in patients receiving pediatric donor corneas compared to a total of 5 rejection episodes in patients receiving adult donor corneas. The average postoperative keratometry was 46.1 diopters for the pediatric donor group and 44.0 diopters for the adult donor group ( P = 0.03). There was no statistically significant difference in average refractive cylinder ( P = 1.0), intraocular pressure ( P = 0.26), or the incidence of graft failure due to rejection ( P = 1.0) between the two groups. The average follow-up time for clear grafts was 58.3 months in the pediatric donor group and 59.9 months in the adult donor group. Conclusions: The incidence of allograft reactions and the postoperative corneal curvature is greater in adult eyes undergoing penetrating keratoplasty with young donor corneas compared to those undergoing penetrating keratoplasty with older donor corneas. There was no difference in the incidence of graft failure due to rejection between the two groups.

Objective: The purpose of the study is to determine safety and efficacy outcomes of excimer laser photorefractive keratectomy (PRK) for the treatment of mild-to-moderate myopia. Design: A prospective, multicenter, phase III clinical trial. Participants: A total of 701 eyes of 701 patients were entered in the study; 612 eyes were examined at 2 years after surgery. Intervention: Intervention was photorefractive keratectomy using the Summit ExciMed UV200LA excimer laser (Summit Technology, Inc., Waltham, MA). The treatment zone diameter used was 4.5 mm in 251 eyes (35.8%) and 5 mm in 450 eyes (64.2%). Attempted corrections ranged from 1.50 to 6.00 diopters (D). Main Outcome Measures: Predictability and stability of refraction, uncorrected and spectacle-corrected visual acuity, refractive and keratometric astigmatism, corneal haze, contrast sensitivity, subjective reported problems of glare and halo, and patient satisfaction were the parameters measured. Results: At 2 years, 407 (66.5%) eyes achieved 20/20 or better uncorrected visual acuity and 564 (92.5%) eyes achieved 20/40 or better visual acuity. Three hundred thirty-six (54.9%) eyes were within 0.5 D and 476 (77.8%) eyes were within 1.0 D of attempted correction. Stability of refraction improved with time; 86.8% of eyes were stable within 1.0 D from 6 to 12 months, 94% were stable from 12 to 18 months, and 96.3% were stable from 18 to 24 months. There was no evidence of progressive or late myopic or hyperopic refractive shifts. One hundred fourteen (18.6%) eyes gained 2 or more lines of spectacle-corrected visual acuity, whereas 42 (6.9%) eyes lost 2 or more lines; however, of the latter, 32 (76.2%) had spectacle-corrected visual acuity of 20/25 or better and 39 (92.9%) eyes had 20/40 or better. Four hundred forty-two (72.2%) corneas were clear, 138 (22.5%) showed trace haze, 20 (3.3%) mild haze, 9 (1.5%) moderate haze, and 3 (0.5%) marked haze. On patient questionnaires, 87 (29.7%) patients reported worsening of glare from preoperative baseline; 133 (50.1 %) reported worsening of halo symptoms from baseline. Conclusions: Photorefractive keratectomy appears effective for myopic corrections of −1.50 to −6.00 D. Uncorrected visual acuity is maximized in most eyes by 3 months, although some patients require between 6 months and 1 year to attain their best postoperative uncorrected visual acuity and some may require from 1 to 2 years for stabilization of refraction. Refraction stabilizes progressively without evidence of late myopic or hyperopic refractive shifts. Optical sequelae of glare and halo occur in some patients treated with a 4.5- or 5-mm treatment zone.

PURPOSE: To compare surgically induced astigmatism (SIA) based on incision site and evaluate the clinical results and astigmatic stability of iris-claw phakic intraocular lens (Artisan lens; Ophtec BV, Groningen, Netherlands) implantation. METHODS: Eighty-five eyes of 53 patients with myopia who underwent Artisan lens implantation with a 6.2-mm incision and follow-up of 6 months were retrospectively observed. SIA was assessed using keratometric astigmatism at 6 months postoperatively for the incision sites of the sclera, limbus, and cornea, and the efficacy, safety, predictability, and astigmatic stability were also calculated. RESULTS: SIA obtained using Naeser’s polar method (KP[90] SIA ) was −0.48 ± 0.35 for scleral incisions, −0.99 ± 0.35 for limbal incisions, and −1.14 ± 0.54 for corneal incisions. Corresponding net astigmatism values, as calculated with KP(90) SIA and KP(135) SIA , were 0.70 ± 0.48 (177°), 1.04 ± 0.37 (175°), and 1.21 ± 0.57 (1°), respectively, with SIA increasing the nearer the incision was to the cornea center. Six months after surgery, the efficacy index was 1.03 and the safety index was 1.08. Ninety-eight percent of patients were within 1.50 diopters of attempted refraction. CONCLUSIONS: The values of SIA after Artisan lens insertion showed significant differences among three incision locations, despite the absence of significant differences in preoperative steep corneal axis astigmatism values at the incision locations. It would be applicable for refractive surgery in the aspect of minimizing astigmatism after surgery. [ J Refract Surg. 2014;30(5):330–335.]