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Maria A Henriquez,1 Lisett Perez,1 Gustavo Hernandez-Sahagun,1 Rolando P Rojas,1 R Doyle Stulting,2 Luis Izquierdo Jr1,3 1Research Department, Oftalmosalud Institute of Eyes, Lima, Perú; 2Stulting Research Center, Woolfson Eye Institute, Atlanta, GA, USA; 3Ophthalmology Department, Universidad Mayor de San Marcos, Lima, PerúCorrespondence: Maria A Henriquez; Luis Izquierdo Jr, Email mariahenriquez1610@gmail.com; izquierdojrluis@gmail.comPurpose: 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.Keywords: crosslinking, keratometric flattening, keratoconus, CXL

R Doyle Stulting,1 Daniel S Durrie,2 Richard J Potvin,3 Steve H Linn,4 Ronald R Krueger,5 Mark C Lobanoff,6 Majid Moshirfar,4,7 Manoj V Motwani,8 Timothy P Lindquist,2 Karl G Stonecipher9 1Woolfson Eye Institute, Atlanta, GA, USA; 2DurrieVision, Kansas City, KS, USA; 3Science in Vision, Akron, NY, USA; 4Hoopes, Durrie, Rivera Research, Draper, UT, USA; 5Cleveland Clinic, Cleveland, OH, USA; 6North Suburban Eye Specialists, Minneapolis, MN, USA; 7John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA; 8Motwani LASIK Institute, San Diego, CA, USA; 9TLC Laser Centers, Greensboro, NC, USACorrespondence: R Doyle Stulting 224 Konawa LN, Loudon, TN 37774, USATel +1 770-804-1684Email ophtrds@emory.eduPurpose: 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.Keywords: LASIK, topography, excimer, laser, PRK, astigmatism

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., (Copyright © 2022 Published by Wolters Kluwer on behalf of ASCRS and ESCRS.)

Purpose: The purpose of the study was to evaluate, as a pilot trial, safety and tolerability of CAM-101 10% and 30% topical ophthalmic fibrinogen-depleted human platelet lysate (FD hPL) solution in patients with dry eye disease (DED) secondary to graft-versus-host disease (GvHD) after 6 weeks of treatment., Design: A phase I/II, pilot, prospective, multicenter, randomized, double-masked clinical trial., Participants: Patients with DED secondary to GvHD., Methods: Sixty-four adult patients were stratified by "symptom severity" (Ocular Surface Disease Index [OSDI], ocular discomfort Visual Analog Scale (VAS), ocular symptom frequency, and use of artificial tears) and then randomized 1:1:1 to CAM-101 (FD hPL) at 10% or 30% concentration or an electrolyte (Plasma-Lyte A) vehicle control, 1 drop in both eyes, 4 times daily, for 42 days. After 42 days, control patients were offered 42 days of open-label treatment with 30% FD hPL., Main Outcome Measures: Primary outcome safety measures were ocular and systemic adverse events and the number of patients in each group with clinically significant change from normal to abnormal in any ocular findings. Secondary outcomes were changes from baseline to day 42 in ocular discomfort, OSDI, fluorescein corneal staining, and lissamine green conjunctival staining relative to the vehicle control. The ocular symptom frequency was assessed on a 100-point VAS., Results: FD hPL 10% and 30% were safe and well tolerated. Relative to the vehicle control, significant decreases from baseline to day 42 were seen in the FD hPL 30% group with regard to ocular discomfort (mean decrease = -18.04; P  = 0.018), frequency of burning/stinging (-20.23; P  = 0.022), eye discomfort (-32.97; P < 0.001), eye dryness (-21.61; P  = 0.020), pain (-15.12; P  = 0.044), photophobia (-24.33; P  = 0.0125), and grittiness (-20.08; P  = 0.0185). Decreases were also seen for itching and foreign body sensation, though not statistically significant. Improvements were seen in tear breakup time (mean increase = 1.30 seconds; P  = 0.082) and the investigator's global evaluation 4-point scale (mean decrease = -0.86; P  = 0.026). Corneal fluorescein staining was not improved. The OSDI had a mean decrease of -8.88 compared to the vehicle, although not statistically significant., Conclusions: Fibrinogen-depleted human platelet lysate appears to be well tolerated, with no significant toxicity at concentrations of 10% and 30%. These initial data suggest some efficacy, especially for subjective outcome measures relative to baseline assessments and treatment with the vehicle, but larger studies are needed to confirm these effects., (© 2022 by the American Academy of Ophthalmology.)

Purpose: 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., Design: Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial., Participants: Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both., Methods: 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., Main Outcome Measures: 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., Results: 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., Conclusions: 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., (Copyright © 2022. Published by Elsevier Inc.)

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.

Purpose: To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal keratitis., Methods: The authors performed a randomized, double-masked, placebo-con- trolled, multicenter clinical trial of 106 patients with active herpes simplex stromal keratitis who had not received any corticosteroids for at least 10 days before study enrollment. Patients were assigned to the placebo group (n = 49) or the steroid group (topical prednisolone phosphate; n = 57); both regimens were tapered over 10 weeks. Both groups received topical trifluridine. Visual acuity assessment and slit-lamp biomicroscopy were performed weekly for 10 weeks, every other week for an additional 6 weeks or until removal from the trial, and at 6 months after randomization., Results: The time to treatment failure (defined by specific criteria as persistent or progressive stromal keratouveitis or an adverse event) was significantly longer in the steroid group compared with the placebo group. Compared with placebo, corticosteroid therapy reduced the risk of persistent or progressive stromal keratouveitis by 68%. The time from randomization to resolution of stromal keratitis and uveitis was significantly shorter in the steroid group compared with the placebo group even though both groups included patients who were removed from the study and treated with topical corticosteroids according to best medical judgment. Nineteen (33%) of the steroid-treated patients and 11 (22%) of the placebo-treated patients completed the 10 weeks of protocol therapy and had stable, noninflamed corneas after 16 weeks. At 6 months after randomization, no clinically or statistically significant differences in visual outcome or recurrent herpetic eye disease were identified between the steroid and placebo groups., Conclusions: The topical corticosteroid regimen used in this study was significantly better than placebo in reducing persistence or progression of stromal inflammation and in shortening the duration of herpes simplex stromal keratitis. Postponing steroids during careful observation for a few weeks delayed resolution of stromal keratitis but had no detrimental effect as assessed by visual outcome at 6 months., (Copyright © 2020. Published by Elsevier Inc.)

Purpose: 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., Methods: 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., Results: 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., Conclusions: 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 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., Setting: Nine practices in the USA., Design: Prospective unmasked study of safety and effectiveness., Methods: 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., Results: 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)., Conclusion: 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., (Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To identify factors related to graft rejection following Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS)., Design: Cohort study within a multicenter randomized clinical trial., Methods: A total of 1330 eyes of 1090 subjects undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0-7 days (n = 675) or 8-14 days (n = 655) and followed for 3 years. Central endothelial cell density (ECD) was determined by a central image analysis reading center. Multivariable Cox models adjusted for PT, recipient diagnosis, and surgeon effect were used to identify factors associated with rejection., Results: Cumulative probability of definite graft rejection was 3.6% (99% confidence interval 2.5%-5.3%). Younger recipient age was associated with graft rejection (P < .001; hazard ratio: 0.53 [0.33, 0.83] per decade). PT, donor-recipient sex mismatch, recipient diagnosis, recipient race, graft size, discontinuation of topical corticosteroids and immune-modulators, prior immunizations within 3 months, and prior glaucoma surgery were not associated with rejection (P > .01). Among clear grafts with an ECD measurement at baseline and 3 years (n = 913), endothelial cell loss (ECL) was greater in eyes that experienced a rejection episode (n = 27) than in those that did not (n = 886) (48% vs 38%, P = .03). Twelve of 44 eyes (27%) with definite graft rejection subsequently failed, comprising 15% of the 79 failures in the CPTS., Conclusions: Graft rejection is uncommon after DSAEK and more likely with younger age, in a study cohort mostly > 50 years old. Rejection increases ECL, but it is not a leading cause of DSAEK failure., (Copyright © 2018 Elsevier Inc. All rights reserved.)

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/cm 2 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., (Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To associate donor, recipient, and operative factors with graft success 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS)., Design: Cohort study within a multicenter, double-masked, randomized clinical trial., Participants: One thousand ninety individuals (1330 study eyes) with a median age of 70 years undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (PACE; 6% of eyes)., Methods: Eyes undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (n = 675) or 8 to 14 days (n = 655). Donor, recipient, and operative parameters were recorded prospectively. Graft failure was defined as regraft for any reason, a graft that failed to clear by 8 weeks after surgery, or an initially clear graft that became and remained cloudy for 90 days. Failure in the first 8 weeks was classified further as primary donor failure or early failure, in the absence or presence of operative complications, respectively. Proportional hazards and logistic regression models were used to estimate risk ratios (RR) and 99% confidence intervals (CIs) for graft failure., Main Outcome Measures: Graft success at 3 years., Results: One thousand two hundred fifty-one of 1330 grafts (94%) remained clear at 3 years and were considered successful. After adjusting for PT, tissue from donors with diabetes (RR, 2.35; 99% CI, 1.03-5.33) and operative complications (RR, 4.21; 99% CI, 1.42-12.47) were associated with increased risk for primary or early failure. Preoperative diagnosis of PACE (RR, 3.59; 99% CI, 1.05-12.24) was associated with increased risk for late failure by 3 years after surgery compared with Fuchs dystrophy. Graft success showed little variation among other factors evaluated, including donor age (RR, 1.19 per decade; 99% CI, 0.91-1.56 per decade), preoperative donor endothelial cell density (RR, 1.10 per 500 cells; 99% CI, 0.74-1.63 per 500 cells), graft diameter (RR, 1.22 per 1 mm; 99% CI, 0.39-3.76 per 1 mm), and injector use for graft insertion (RR, 0.92; 99% CI, 0.40-2.10)., Conclusions: Descemet stripping automated endothelial keratoplasty success in the early and entire postoperative period is more likely when the donor did not have diabetes and was without operative complications and in the long-term postoperative period in recipients with Fuchs dystrophy compared with those with PACE. Mechanisms whereby diabetic donors and PACE recipients reduce the rate of graft success after DSAEK warrant further study., (Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2018 Elsevier Inc. All rights reserved.)

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.

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., (Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

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.

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., (Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

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 (31.5%) 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., (Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2016 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

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 assess the effect of preoperative topical nonsteroidal antiinflammatory drugs (NSAIDs) on postoperative pain after laser-assisted subepithelial keratectomy (LASEK) and to investigate their mechanism., Setting: Severance Eye Hospital and Saeyan Eye Clinic, Seoul, South Korea., Design: Prospective randomized clinical trial., Methods: Participants in 2 related studies were assessed. Study 1 comprised patients scheduled for bilateral LASEK (Group 1) who were randomized to receive an NSAID in 1 eye and a placebo in the fellow eye 30, 20, and 10 minutes before LASEK. Postoperative pain, glare, tearing, and irritation were assessed using a visual analog scale. Study 2 comprised healthy subjects (Group 2) who were randomly divided into subgroups. The participants in these subgroups were randomized to receive ketorolac tromethamine 0.5% in 1 eye and placebo (ofloxacin 0.3%) in the fellow eye (Group 2A), proparacaine hydrochloride 0.5% in 1 eye and placebo in the fellow eye (Group 2B), or ketorolac tromethamine 0.5% in 1 eye and placebo in the fellow eye, followed 10 minutes later by 1 drop of proparacaine hydrochloride 0.5% in both eyes (Group 2C). In all 3 groups, corneal sensitivity was measured after 1, 2, and 6 hours., Results: The mean postoperative pain score in the NSAID-pretreated eye was statistically significantly lower than in the placebo-pretreated eye 6, 12, and 24 hours postoperatively (P < .05). The mean corneal sensitivity was statistically significantly lower in the NSAID-treated eye than in the placebo-treated eye at 1 and 2 hours in Groups 2A and 2C (P < .05)., Conclusion: Preoperative administration of topical NSAIDs before LASEK effectively reduces postoperative pain., Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned., (Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

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., (Copyright 2015, SLACK Incorporated.)

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., (© ARVO.)

Purpose: 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., Design: Prospective randomized trial of a standard epithelium-off CXL protocol., Participants: Patients with progressive KC (24 eyes of 21 patients) or postrefractive surgery ectasia (27 eyes of 23 patients) were enrolled., Methods: 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., Main Outcome Measures: Corneal hysteresis, corneal resistance factor, 37-s generation manufacturer-supplied ORA variables, and 15 investigator-derived ORA variables., Results: 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., Conclusions: 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 eye-whitening 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., (Published by Elsevier Inc.)

Purpose: To evaluate dry eye and meibomian gland dysfunction after cataract surgery., Design: Prospective observational case series., Methods: We studied 58 eyes of 48 patients who underwent phacoemulsification and evaluated them preoperatively and at 1 month and 3 months postoperatively. Ocular symptom scores, lid margin abnormalities, superficial punctate keratopathies (SPKs), tear film break-up time (TBUT), Schirmer test, lower tear meniscus height, depth, and area using Fourier domain optical coherence tomography, meibum expressibility and images of the meibomian glands using meibography were measured., Results: The ocular symptom scores were worse at 1 month and 3 months postoperatively (P < 0.001 and P < 0.001, respectively). Lid margin abnormalities were significantly increased (P < 0.001 and P < 0.001, respectively) and TBUT decreased postoperatively (P < 0.001 and P < 0.001, respectively). Meibum expressibility decreased at 3 months postoperatively (P = 0.016); however, meibography score, SPK, lower tear meniscus height, depth and area and the Schirmer test did not change significantly postoperatively (all P values >0.05)., Conclusion: Meibomian gland function may be altered without accompanying structural changes after cataract surgery., (Copyright © 2014 Elsevier Inc. All rights reserved.)

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., (Copyright 2014, SLACK Incorporated.)

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 μm; range: 43 to 62 μm), and 2.5 and 1 mm nasal and 2 mm temporal to the corneal apex (46.66 ± 4.53 μm; range: 39 to 57 μm) compared to preoperative values (P < .05 for all measurements). Epithelial thickness standard deviations were significantly lower (by 3 to 6 μm) 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., (Copyright 2014, SLACK Incorporated.)

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., (Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the complications of cosmetic wide conjunctivectomy and postoperative topical mitomycin C application with or without bevacizumab injection., Design: Cross-sectional cohort study., Methods: Medical records of 1713 consecutive subjects who received cosmetic wide conjunctivectomy plus postoperative topical mitomycin C by a single surgeon at a single center with or without bevacizumab injection from November 2007 to May 2010 were reviewed. A telephone interview was conducted with 557 of the subjects who could be contacted and agreed to participate in the study. Complications, recurrences, and patient satisfaction were the main outcome measures., Results: A total of 1713 consecutive patients underwent cosmetic wide conjunctivectomy to treat conjunctival hyperemia. Ocular diagnoses in the medical records at the time of surgery included hyperemia (8.8%), pterygium (14.0%), dry eye (3.5%), pinguecula (1.5%), and conjunctival disorder (23.3%). For the remaining 48.9% of subjects, the diagnosis was not mentioned, or the surgical procedure was for cosmetic purposes. Patients were followed for a mean of 10.9 months (range, 0-30.3 months). The overall complication rate was 82.9%, of which 55.6% were considered severe (fibrovascular conjunctival tissue proliferation, 43.8%; scleral thinning, 4.4%; scleral thinning with calcified plaques, 6.2%; intraocular pressure elevation, 13.1%; diplopia, 3.6%; and recurrence of hyperemic conjunctiva, 28.1%)., Conclusions: Cosmetic wide conjunctivectomy plus postoperative topical mitomycin C with or without bevacizumab injection has a high rate of complications and reoperations., (Copyright © 2013 Elsevier Inc. All rights reserved.)

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 © 2013 Elsevier Ltd. All rights reserved.)

Purpose: To determine the minimum depth of phototherapeutic keratectomy (PTK) required for diffuse haze removal in granular corneal dystrophy type 2 and to determine whether Fourier domain optical coherence tomography (FD-OCT) can be an effective technique for predicting the exact required depth of ablation., Methods: The depth of ablation used for diffuse stromal haze removal was evaluated with the slit lamp and serially taken photographs during the PTK procedure. The depth of diffuse haze was measured preoperatively using FD-OCT., Results: Forty-three eyes of 30 patients were included in this study. The mean age of the patients was 62.0 ± 8.4 years. The mean depth of PTK required was 43.7 ± 6.2 μm (range, 31-59 μm). The mean follow-up period for 29 eyes of 22 patients, who had follow-up periods of more than 6 months, was 21.0 ± 12.0 months. The mean best spectacle-corrected visual acuity of these 29 eyes was 0.43 ± 0.15 preoperatively and 0.71 ± 0.16 (P = 0.022) 1 month postoperatively. Of the 43 eyes of 30 patients, FD-OCT was evaluated in 29 eyes of 22 patients. The mean preoperative depth of diffuse haze using FD-OCT was 44.3 ± 6.4 μm. The mean depth of ablation required to remove diffuse stromal haze was 44.5 ± 5.9 μm. The actual ablated depths correlated well with the depth of haze detected by FD-OCT preoperatively (intraclass correlation coefficient = 0.719)., Conclusions: FD-OCT is an accurate method of predicting the depth of PTK required to remove visually significant diffuse haze in patients with granular corneal dystrophy type 2. We advocate the use of slit-lamp biomicroscopy after the initial 30-μm ablation to determine the necessity for any further ablation.

Purpose: To assess corneal microarchitecture and regional epithelial thickness profile in eyes with keratoconus, postoperative corneal ectasia (ectasia), and normal unoperated eyes (controls) using spectral-domain optical coherence tomography (SD-OCT)., Methods: Regional corneal epithelial thickness profiles were measured with anterior segment SD-OCT (Optovue RTVue-100, Optovue Inc., Fremont, CA). Epithelial thickness was assessed at 21 points, 0.5 mm apart, across the central 6-mm of the corneal apex in the horizontal and vertical meridians., Results: One hundred twenty eyes were evaluated, including 49 eyes from 29 patients with keratoconus, 32 eyes from 16 patients with ectasia, and 39 eyes from 21 control patients. Average epithelial thickness at the corneal apex was 41.18 ± 6.47 μm (range: 30 to 51 μm) for keratoconus, 46.5 ± 6.72 μm for ectasia (range: 34 to 60 μm), and 50.45 ± 3.92 μm for controls (range: 42 to 55 μm). Apical epithelial thickness was significantly thinner in eyes with keratoconus (P < .0001) and ectasia (P = .0007) than in controls. Epithelial thickness ranges in all other areas varied widely for keratoconus (range: 21 to 101 μm) and ectasia (range: 30 to 82 μm) compared to controls (range: 43 to 64) (P = .0063)., Conclusion: SD-OCT demonstrated significant central and regional epithelial thickness profile differences between keratoconus, ectasia, and control eyes, with significant variability and unpredictability in ectatic eyes. This regional irregularity may necessitate direct epithelial thickness measurement for treatments where underlying stromal variations may be clinically relevant, including corneal collagen cross-linking or topography-guided ablations., (Copyright 2013, SLACK Incorporated.)

Objectives: The free-living amoeba Acanthamoeba castellanii is a rare cause of contact lens-associated microbial keratitis. The cyst stage of this amoeba is noted for its resistance to disinfection by multipurpose contact lens solutions (MPS). This report examines and reviews the potential survival modes of A. castellanii in MPS., Methods: Trophozoites of A. castellanii (ATCC 30234) at densities from 10 to near 10 were incubated in 3 different MPS in a laminar flow hood for 24 hours at ambient temperatures. The dried films of MPS and phosphate-buffered saline (PBS) controls were examined before and after the addition of a peptone-yeast extract-glucose recovery broth (PYG) for the presence of amoeboid trophozoites and resistance stages over at least 7 days. The parallel exposure of trophozoites to MPS without evaporation or addition of PYG was similarly examined., Results: Amoeboid trophozoites were not recovered in PYG nor were cyst-like structures observed in any MPS with near 10 densities. Progressively with 10 to 10 trophozoites, varied survival modes, particularly aggregates of trophozoites associated with cyst-like structures and occasional amoeboid forms and double-walled cysts with ostioles, became more evident. These morphotypes were most prominent after evaporation and typically first observed in the PYG., Conclusions: Trophozoites of A. castellanii near 10 and progressively to 10 densities are capable of expressing a variety of "short-term" survival modes in MPS, notably with the added stress of evaporation. Expression of these alternate survival modes in MPS may relate, in part, to contamination of contact lens cases and difficulties in developing standardized MPS efficacy tests.