Comparison of Efficacy of Difluprednate 0.05% and Loteprednol Gel 0.5% After Cataract Surgery.

PURPOSE: To compare the outcomes and complications of topical difluprednate 0.05% and loteprednol gel 0.5% after routine cataract surgery. METHODS: Subjects received either difluprednate emulsion 0.05% (n=30 eyes) or loteprednol gel 0.5% (n=30 eyes) after routine cataract surgery. Topical steroid drops were initiated 3 days before cataract surgery and continued for 2 weeks postoperatively. Anterior chamber (AC) cell grade, corneal edema, corneal pachymetry, visual acuity, ocular surface quality (Oxford scale), and intraocular pressure (IOP) were evaluated at 1 day, 1 week, and 1 month postoperatively. RESULTS: Patients treated with difluprednate or loteprednol had statistically similar resolution of their AC cell grade and corneal edema at 1 day, 1 week, and 1 month postoperatively (P>0.05 at each study visit). Difluprednate-treated and loteprednol-treated eyes achieved a mean best-corrected visual acuity of at least 20/25 by 1 week postoperatively (0.055 and 0.061 logarithm of the minimum angle of resolution, respectively; P=0.82). The nasal ocular surface quality at 1 week had improved in loteprednol-treated eyes compared with difluprednate-treated eyes (1.0 vs. 1.9 Oxford score, respectively; P<0.001), but similar at all other visits. There was no statistical difference between IOP levels between both treatment groups (P>0.05). In the difluprednate-treated group, one patient developed rebound inflammation and two patients developed cystoid macular edema at their 1-month postoperative visit. CONCLUSIONS: The anti-inflammatory effect, visual recovery, and IOP of patients using topical difluprednate or loteprednol gel after cataract surgery are equivalent. There may be an additional short-term benefit of loteprednol gel in protecting the ocular surface after cataract surgery.

Quantitative Assessment of Dry Eye Parameters After Müller's Muscle-Conjunctival Resection.

PURPOSE: Müller's muscle-conjunctival resection (MMCR) is a highly effective technique to correct upper eyelid ptosis. However, several authorities have raised concerns about the possibility of postoperative ocular surface dryness. This study was performed to assess the impact of MMCR on clinically meaningful parameters of the ocular surface. METHODS: In adult patients, tear break-up time, lipid layer thickness, and osmolarity were measured via direct observation, interferometry, and impedance measurements before surgery and 3 months after surgery in patients who underwent MMCR. Statistical analysis was performed via a dedicated software package. RESULTS: Fifteen eyes of 14 patients were included in the study. Mean pre- and postoperative tear break-up times were 12.71 ± 2.20 and 12.43 ± 2.41 seconds, respectively (p = 0.1648). Preoperatively, the mean lipid layer thickness measurement was 91.00 ± 7.02 nm, whereas the mean postoperative value was 88.86 ± 21.36 nm (p = 0.6613). The mean preoperative tear osmolarity measured 291.4 ± 8.86 mOsm/l, and the mean postoperative measurement was 289.86 ± 9.74 mOsm/l (p = 0.2652). CONCLUSIONS: MMCR does not appear to change clinically meaningful ocular surface disease parameters, and postoperative dryness did not result from this procedure. In appropriately selected patients, MMCR can be safely performed without increased concerns regarding postoperative dry eye disease.

Evaluating the effects of Botulinum Toxin A on tear metrics in patients with hemifacial spasm.

Hemifacial spasm has been previously shown to result in dry eye and ocular surface diseases. This study was performed to assess the impact of chemodenervation with botulinum toxin on clinically-relevant metrics of tears. Tear osmolarity and lipid layer thickness were measured in patients with hemifacial spasm after they achieved relief from hemifacial spasm via botulinum toxin injections. Twelve eyes of 6 patients with hemifacial spasm (2 men and 4 women; mean age 55.5 years) were assessed in accordance with the Declaration of Helsinki and IRB approval. The mean tear osmolarities were 300.8 mOsm (standard deviation = 7.44 mOsm) and 293.0 mOsm (standard deviation = 7.01 mOsm) for treated and untreated eyes, respectively, and this difference was not statistically significant (p = 0.097). The mean lipid layer thicknesses of the tear film were 78.7 nm (standard deviation = 18.0 nm) and 71.5 nm (standard deviation = 25.2 nm) for treated and untreated eyes, respectively, and these values were not statistically significantly different (p = 0.671). Although previous investigations have demonstrated significant dry eye disease in patients with hemifacial spasm, successful chemodenervation with botulinum toxin appears to result in tear osmolarities and lipid layer thicknesses that were comparable in treated and untreated eyes. This finding may represent an additional benefit to treatment of hemifacial spasm.

Long-term outcomes of boston type 1 keratoprosthesis implantation: a retrospective multicenter cohort.

PURPOSE: To study the long-term outcomes of Boston type 1 keratoprosthesis (KPro) surgery. DESIGN: Retrospective, multicenter case series. PARTICIPANTS: A total of 158 eyes of 150 patients underwent KPro implantation at 5 participating tertiary centers in the United States between January 2003 and December 2006. Of those, 139 eyes of 133 patients were included in the analyses. METHODS: The medical records of consecutive adult patients who received KPro surgery were reviewed. All patients with at least 1 postoperative visit were retained in the outcomes analyses. In eyes in which a repeat KPro procedure was performed, only the outcomes of the initial surgery were analyzed. MAIN OUTCOME MEASURES: Visual acuity (VA) outcomes, postoperative complications, and device retention. RESULTS: The mean follow-up was 46.7 ± 26 months with all but 4 eyes having at least 6 months of follow-up. Preoperatively, only 10.8% of the eyes had VA of ≥ 20/200. Postoperatively, the VA in 70% of eyes improved to ≥ 20/200. The probability of maintaining VA of ≥ 20/200 at 7 years was 50%. The device retention rate was estimated at 67% at 7 years. The 7-year cumulative incidence of complications was 49.7% for retroprosthetic membrane formation, 21.6% for glaucoma surgery, 18.6% for retinal detachment, and 15.5% for endophthalmitis. CONCLUSIONS: Although the risk for complications with longer follow-up seemed to increase, this large multicenter cohort demonstrates favorable outcomes with KPro, with a large number of patients achieving and retaining useful vision over a 7-year period.

Impact of advanced image-guided systems on correction of corneal astigmatism during FLACS.

PURPOSE: To determine the effectiveness of the correction of corneal astigmatism using the Alcon Image Guidance (IG) system vs manual marking in the orientation of femtosecond laser-assisted cataract surgery (FLACS). SETTING: Private practice, Albany, New York. DESIGN: Retrospective review. METHODS: Patients who underwent FLACS with IG and without IG were from January 2018 to June 2022 investigated. Variables including preoperative keratometry values, cylinder, spherical equivalent (SE), and visual acuity (VA) were collected, as well as the cyclorotation angle delta registered by IG, postoperative refractive cylinder, SE, and VA. The primary outcome was postoperative refractive cylinder in patients with IG compared with those without IG. RESULTS: A total of 160 eyes were included, with 103 eyes that had IG and 57 eyes that did not have IG. Postoperative cylinder was similar in those with IG (0.31 ± 0.36 diopters [D]) compared with those without IG (0.31 ± 0.37 D) ( P = .97). Average cyclorotation in the IG group was 2.82 ± 3.03 degrees. When cyclorotation was stratified into 3 groups (<2.8 degrees, 2.8 to 8.5 degrees, >8.5 degrees), no differences were found in postoperative refractive cylinder ( P = .35). CONCLUSIONS: Patients who underwent FLACS with IG had similar postoperative cylinder outcomes compared with those without IG. This study suggests that the accommodation of cyclotorsion using an advanced IG system is similar to that obtained with manual marking techniques in patients having 2 D or less of astigmatism corrected.

The effect of donor age on penetrating keratoplasty for endothelial disease: graft survival after 10 years in the Cornea Donor Study.

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.

Recipient risk factors for graft failure in the cornea donor study.

PURPOSE: To identify recipient factors that may be related to risk of corneal graft failure. DESIGN: Multicenter, prospective, double-masked, controlled clinical trial. PARTICIPANTS: One thousand ninety subjects undergoing corneal transplantation for a moderate-risk condition (principally Fuchs' dystrophy or pseudophakic corneal edema). METHODS: Donor corneas were assigned using a random approach without respect to recipient factors, and surgeons were masked to information about the donor cornea, including donor age. Surgery and postoperative care were performed according to the surgeons' usual routines, and subjects were followed up for 5 years. Baseline factors were evaluated for their association with graft failure. MAIN OUTCOME MEASURES: Graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque to compromise vision for a minimum of 3 consecutive months. RESULTS: Preoperative diagnosis of pseudophakic or aphakic corneal edema increased graft failure risk approximately 4-fold compared with Fuchs' dystrophy (27% vs. 7%). Prior glaucoma surgery with preoperative glaucoma medication use substantially increased the graft failure rate. Factors not strongly associated with graft failure included age, gender, diabetes, smoking, and graft size. CONCLUSIONS: The risk of graft failure is significantly increased in eyes with pseudophakic or aphakic corneal edema compared with Fuchs' dystrophy, independent of lens status, and in eyes with a history of glaucoma. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study.

Importance: Determining factors associated with endothelial cell loss after Descemet stripping automated endothelial keratoplasty (DSAEK) could improve long-term graft survival. Objective: To evaluate the associations of donor, recipient, and operative factors with endothelial cell density (ECD) 3 years after DSAEK in the Cornea Preservation Time Study. Design, Setting, and Participants: This cohort study was a secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. Individuals undergoing DSAEK for Fuchs dystrophy or pseudophakic/aphakic corneal edema were included. Interventions: The DSAEK procedure, with random assignment of a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days. Main Outcomes and Measures: Endothelial cell density at 3 years as determined by a reading center from eye bank and clinical specular or confocal central endothelial images. Results: The study included 1090 participants (median age, 70 years) with 1330 affected eyes (240 bilateral cases [22.0%]), who underwent DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic/aphakic corneal edema (PACE) (75 eyes [5.6%]). Of these, 801 eyes (60.2%) belonged to women and 1207 (90.8%) to white individuals. A total of 749 participants (913 eyes; 164 [21.9%] bilateral cases) had functioning grafts with acceptable endothelial images preoperatively and at 3 years postoperatively and were included in this analysis. Factors associated with a lower ECD at 3 years (estimated effect with 99% CI) in the final multivariable model included donors with diabetes (-103 [-196 to -9] cells/mm2), lower screening ECD (-234 [-331 to -137] per 500 cells/mm2), recipient diagnosis of PACE (-257 [-483 to -31] in cells/mm2), and operative complications (-324 [-516 to -133] in cells/mm2). Endothelial cell loss (ECL) from a preoperative measurement to a 3-year postoperative measurement was 47% (99% CI, 42%-52%) for participants receiving tissue from donors with diabetes vs 43% (99% CI, 39%-48%) without diabetes; it was 53% (99% CI, 44%-62%) for participants diagnosed with PACE vs 44% (99% CI, 39%-49%) for those diagnosed with Fuchs dystrophy, and 55% (99% CI, 48%-63%) in participants who experienced operative complications vs 44% (99% CI, 39%-48%) in those who did not. No other donor, recipient, or operative factors were significantly associated with 3-year ECD. Conclusions and Relevance: Donor diabetes, lower screening ECD, a PACE diagnosis in the recipient, and operative complications were associated with lower ECD at 3 years after DSAEK surgery and may be associated with long-term graft success. While causation cannot be inferred, further studies on the association of donor diabetes and PACE in recipients with lower 3-year ECD warrant further study.

The effect of donor age on corneal transplantation outcome results of the cornea donor study.

OBJECTIVE: To determine whether graft survival over a 5-year follow-up period using corneal tissue from donors older than 65 is similar to graft survival using corneas from younger donors. DESIGN: Multicenter prospective, double-masked, controlled clinical trial. PARTICIPANTS: One thousand ninety subjects undergoing corneal transplantation for a moderate-risk condition (principally Fuchs' dystrophy or pseudophakic corneal edema); 11 subjects with ineligible diagnoses were not included. METHODS: Forty-three participating eye banks provided corneas from donors in the age range of 12 to 75 with endothelial cell densities of 2300 to 3300 cells/mm(2), using a random approach without respect to recipient factors. The 105 participating surgeons at 80 sites were masked to information about the donor cornea including donor age. Surgery and postoperative care were performed according to the surgeons' usual routines. Subjects were observed for 5 years. MAIN OUTCOME MEASURES: Graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque as to compromise vision for a minimum of 3 consecutive months. RESULTS: The 5-year cumulative probability of graft survival was 86% in both the <66.0 donor age group and the >/=66.0 donor age group (difference = 0%, upper limit of 1-sided 95% confidence interval = 4%). In a statistical model with donor age as a continuous variable, there was no significant relationship between donor age and outcome (P = 0.11). Three graft failures were due to primary donor failure, 8 to uncorrectable refractive error, 48 to graft rejection, 46 to endothelial decompensation (23 of which had a prior, resolved episode of probable or definite graft rejection), and 30 to other causes. Distributions of the causes of graft failure did not differ between donor age groups. CONCLUSIONS: Five-year graft survivals for cornea transplants at moderate risk for failure are similar using corneas from donors >/= 66.0 years and donors < 66.0. Surgeons and patients now have evidence that corneas comparable in quality to those used in this study from donors through age 75 are suitable for transplantation.

Donor age and corneal endothelial cell loss 5 years after successful corneal transplantation. Specular microscopy ancillary study results.

OBJECTIVE: To determine whether endothelial cell loss 5 years after successful corneal transplantation is related to the age of the donor. DESIGN: Multicenter, prospective, double-masked clinical trial. PARTICIPANTS: Three hundred forty-seven subjects participating in the Cornea Donor Study who had not experienced graft failure 5 years after corneal transplantation for a moderate-risk condition (principally Fuchs' dystrophy or pseudophakic corneal edema). TESTING: Specular microscopic images of donor corneas obtained before surgery and postoperatively at 6 months, 12 months, and then annually through 5 years were submitted to a central reading center to measure endothelial cell density (ECD). MAIN OUTCOME MEASURE: Endothelial cell density at 5 years. RESULTS: At 5 years, there was a substantial decrease in ECD from baseline for all donor ages. Subjects who received a cornea from a donor 12 to 65 years old experienced a median cell loss of 69% in the study eye, resulting in a 5-year median ECD of 824 cells/mm(2) (interquartile range, 613-1342), whereas subjects who received a cornea from a donor 66 to 75 years old experienced a cell loss of 75%, resulting in a median 5-year ECD of 654 cells/mm(2) (interquartile range, 538-986) (P [adjusted for baseline ECD] = 0.04). Statistically, there was a weak negative association between ECD and donor age analyzed as a continuous variable (r [adjusted for baseline ECD] = -0.19; 95% confidence interval, -0.29 to -0.08). CONCLUSIONS: Endothelial cell loss is substantial in the 5 years after corneal transplantation. There is a slight association between cell loss and donor age. This finding emphasizes the importance of longer-term follow-up of this cohort to determine if this relationship affects graft survival.

Macular degeneration in a patient with aceruloplasminemia, a disease associated with retinal iron overload.

PURPOSE: To provide the first ophthalmic case report of a Caucasian patient with the rare autosomal recessive disease aceruloplasminemia, which results in iron overload in the retina, brain, and pancreas. DESIGN: Single observational case report. METHODS: Perls' staining of a conjunctival biopsy was used to detect elevated iron levels in the conjunctival epithelium. Fundus photography, fluorescein angiography, and electroretinography were used to document retinal appearance and function. RESULTS: Unlike a report of a Japanese patient with aceruloplasminemia, who had midperipheral retinal pigment epithelium (RPE) cell atrophy and yellowish discoloration of the fundus, our Caucasian patient had a maculopathy. Beginning at age 47, he had development and progression of multiple subretinal yellowish-white lesions and RPE cell atrophy. To confirm tissue iron overload in our patient, we took the novel approach of a conjunctival biopsy, which showed Perls' Prussian blue-positive epithelial cells. CONCLUSIONS: Given our recent finding of elevated iron levels in the RPE of patients with age-related macular degeneration (AMD), it is interesting that retinal iron overload in aceruloplasminemia is associated with a maculopathy that clinically resembles AMD. This finding supports the hypothesis that retinal iron homeostasis is essential for normal retinal function. Disruption of iron homeostasis could contribute to the pathogenesis of AMD.

Impact of donor characteristics on 2-year Descemet stripping automated endothelial keratoplasty outcomes in patients with Fuchs endothelial dystrophy.

PURPOSE: The aim of this study was to determine the relationship between donor tissue characteristics and surgical outcomes in patients with Fuchs endothelial dystrophy (FED) 2 years after undergoing Descemet stripping automated endothelial keratoplasty (DSAEK). METHODS: A retrospective chart review was performed identifying 70 eyes with FED that underwent DSAEK. Donor endothelial cell density (ECD), donor death to preservation time, donor storage time, donor age, and postoperative recipient ECD were evaluated. Statistical analysis was performed using univariate linear regression analysis and bidirectional elimination multiple stepwise linear regression. RESULTS: Cornea donor age was a predictor of postoperative ECD at postoperative years 1 and 2 (P = 0.02, adjusted R2 = 0.07 and P = 0.002, adjusted R2 = 0.13, respectively). Donor age was also a predictor of postoperative ECD at years 1 and 2 after taking into account donor ECD, death to preservation time, and donor storage time (P = 0.02, adjusted R2 = 0.62 and P = 0.002, adjusted R2 = 0.12, respectively). Donor death to preservation time was a predictor of postoperative ECD at only postoperative year 2 (P = 0.03, adjusted R2 = 0.05). Donor storage time and donor ECD did not significantly impact postoperative ECD. CONCLUSIONS: Although donor age seems to have a statistically significant impact on postoperative ECD in patients with FED undergoing DSAEK, the relationship is weak. Other donor parameters did not have a consistent or significant impact on postoperative ECD.

Anisometropic amblyopia: axial length versus corneal curvature in children with severe refractive imbalance.

PURPOSE: To define the ocular parameters associated with anisometropic ambylopia in children with severe hyperopia, myopia, or astigmatism in 1 eye. METHODS: Anisometropic and fellow eyes of 13 children, ages 7-8, with anisometropia >3.0 D and amblyopia without strabismus or other visually significant ocular pathology were studied. Axial length, corneal curvature, anterior chamber depth, and corneal diameter measurements of amblyopic and fellow eyes were obtained using the IOL Master (Carl Zeiss Meditec, Dublin, CA). RESULTS: Comparing amblyopic eyes with unaffected fellow eyes as reference, patients with anisohyperopia had shorter axial lengths by an average of 1.49 mm (p = 0.001), and patients with anisomyopia had longer axial lengths by an average of 2.26 mm. Corneal astigmatism was the source of amblyogenic refractive error in 1 child. CONCLUSIONS: In children with anisometropic amblyopia, interocular differences in spherical refractive error was attributed to axial length with no differences in corneal curvature, whereas the anisoastigmatism observed in 1 case was attributed to asymmetric corneal curvature.

Nd:YAG photodestruction of a presumed corneal Toxocara canis larva.

PURPOSE: To describe the technique of Nd:YAG photodestruction of a presumed Toxocara canis corneal larval migrans and to report the unique clinical combination of a corneal nematode and diffuse unilateral subacute neuroretinitis (DUSN). METHODS: Clinical case report. RESULTS: A 63-year-old white male presented with idiopathic neuroretinitis treated empirically with systemic anti inflammatory therapy. Subsequently, he developed keratouveitis with an obvious corneal larva. Serology was positive for T. canis. Laser destruction of the larva combined with topical steroid and oral albendazole therapy led to initial resolution, followed by 1 episode of recurrent keratouveitis without identified ocular surface or intraocular larvae. This was cleared with topical steroids. A second empiric course of oral albendazole was also administered. The patient has shown no ocular recurrences or evidence of systemic involvement 1 year after the second course of treatment. CONCLUSIONS: Corneal larvae can be safely and successfully destroyed by Nd:YAG photodestruction. T. canis may be one of several nematodes responsible for DUSN. A careful examination of the anterior segment is essential in the management of patients with DUSN.

Elevated intraocular pressure-induced interlamellar stromal keratitis.

PURPOSE: To describe a series of cases (Elevated Intraocular Pressure Induced Interlamellar Stromal Keratitis (PISK)) that appears to be identical to post-laser in situ keratomileusis (LASIK) diffuse lamellar keratitis (DLK), but was present at a later time frame and was associated with a significant elevation of intraocular pressure (IOP). Unlike DLK, this syndrome is not steroid responsive, but resolves with a lowering of the IOP. DESIGN: Retrospective, noncomparative, small case series. PARTICIPANTS: The medical records of four LASIK patients with IOP-induced interface changes for the 1-year period March 2000 to March 2001 were reviewed retrospectively. MAIN OUTCOME MEASURE: Slit-lamp appearance. RESULTS: In the four cases presented, the slit-lamp findings and visual degradation appeared identical to DLK. All cases, however, presented outside of the first postoperative week and were not associated with any antecedent trauma. All four cases failed to respond to high-dose topical steroids. Significant IOP elevations were noted in all cases, and the interface changes responded dramatically to both a lowering of the IOP and a discontinuation or lowering of the topical steroids. CONCLUSIONS: Elevated IOP-induced post-LASIK interface keratitis (PISK) is a poorly documented phenomena. Because the condition may be caused by or worsened by frequent topical steroids, early recognition is important. Treatment consists primarily of normalizing the IOP.