Trends of Surgery, Patient, and Surgeon Characteristics for Corneal Transplants in the Medicare Population From 2011 to 2020.

PURPOSE: The aim of this study was to describe recent trends in corneal transplants and patient and surgeon characteristics for corneal transplants that occurred in the Medicare population. METHODS: This was a retrospective, cross-sectional study using Current Procedural Terminology codes. We identified Medicare Fee-For-Service (FFS) claims for different types of corneal transplant procedures performed on Medicare beneficiaries aged 65 years or older from 2011 to 2020. Number and types of corneal transplants performed each year and patient and surgeon demographics and characteristics were analyzed. RESULTS: We analyzed 148,981 corneal transplants performed by 2972 surgeons within the study period. Most corneal transplants performed were endothelial keratoplasties (70.1%). Most patients were women (60.3%) and White (85.8%). 18.2% of patients lived in a rural area, whereas only 3.5% of transplants occurred in a rural area and 5% of surgeons practiced in a rural area. Male surgeons represented 77.8% of all surgeons and performed 84.9% of all corneal transplants in the study period. The proportion of corneal transplants performed by female surgeons gradually increased over time, from 12.1% in 2011 to 19.0% in 2020. The proportion of female surgeons also increased from 16.2% in 2011 to 23.8% in 2020. Most surgeons (67%) performed <6 corneal transplants per year. CONCLUSIONS: Although the number of female corneal transplant surgeons has increased over time, women remain underrepresented in the surgical workforce. Further investigation should be conducted to identify the underlying reason and address the identified disparities within the landscape of corneal transplantation.

Quality assurance in corneal transplants: Donor cornea assessment and oversight.

The cornea is the most frequently transplanted human tissue, and corneal transplantation represents the most successful allogeneic transplant worldwide. In order to obtain good surgical outcome and visual rehabilitation and to ensure the safety of the recipient, accurate screening of donors and donor tissues is necessary throughout the process. This mitigates the risks of transmission to the recipient, including infectious diseases and environmental contaminants, and ensures high optical and functional quality of the tissues. The process can be divided into 3 stages: (1) donor evaluation and selection before tissue harvest performed by the retrieval team, (2) tissue analysis during the storage phase conducted by the eye bank technicians after the retrieval, and, (3) tissue quality checks undertaken by the surgeons in the operating room before transplantation. Although process improvements over the years have greatly enhanced safety, quality, and outcome of the corneal transplants, a lack of standardization between centers during certain phases of the process still remains, and may impact on the quality and number of transplanted corneas. Here we detail the donor screening process for the retrieval teams, eye bank operators. and ophthalmic surgeons and examine the limitations associated with each of these stages.

Economic appraisal of prosthetic replacement of ocular surface ecosystem in Canada.

OBJECTIVE: To perform an economic appraisal of the Prosthetic Replacement of Ocular Surface Ecosystem (PROSE; BostonSight, Needham Heights, Mass.) lens in patients with a distorted corneal surface or ocular surface disease in Canada. DESIGN: Retrospective observational cohort study with cost, cost-utility, and benefit-cost analyses. PARTICIPANTS: Patients who received PROSE from the only PROSE clinic in Canada from 2018 to 2020. METHODS: Visual acuity (VA) outcomes of the participants were assessed. Benefits were defined as VA improvements that were converted into utilities and then quality-adjusted life years. Economic values were derived via government statements, clinic financial statements, and published literature. RESULTS: Average best-corrected VA (BCVA) improvement was -0.42 ± 0.41 logMAR (p = 2.68 × 10-13) or Snellen 20/53 for the overall cohort, -0.51 ± 0.48 (p = 5.42 × 10-8) or Snellen 20/65 for distorted corneal surface patients, and -0.31 ± 0.30 (p = 1.30 × 10-7) or Snellen 20/41 for ocular surface disease patients. This corresponded to discounted quality-adjusted life year gains of 0.51, 0.65, and 0.42, respectively, over an estimated 5-year PROSE device lifespan. Average cost to fit a patient with PROSE was USD$5 469.85 (CAD$7 087.28), of which USD$4 971.38 (CAD$6 441.42) was clinic cost and USD$498.47 (CAD$645.87) was patient cost. Cost-utility was USD$10 256.47 (CAD$13 289.31) for the overall cohort, USD$8 439.79 (CAD$10 935.44) for distorted corneal surface patients, and US$13 069.90 (CAD$16 934.67) for ocular surface disease patients. The benefit-cost ratio was 34.4 for all, 43.8 for distorted corneal surface patients, and 28.3 for ocular surface disease patients. CONCLUSIONS: Our economic appraisal demonstrated that PROSE treatment provides a significant, cost-effective benefit to Canadian patients with distorted corneal surfaces and ocular surface diseases. This indicates that PROSE clinics are an efficient investment.

Application of data mining algorithms to study data trends for corneal transplantation.

PURPOSE: To utilize data mining for analysis of corneal transplantations (CT) in Florida from 2005-2014, segmented by demographics, geography, and transplantation technique. METHODS: A retrospective, database study was performed utilizing data queried from the Healthcare and Cost Utilization Project using Current Procedural Terminology codes for lamellar keratoplasty (ALK), endothelial keratoplasty (EK), and penetrating keratoplasty (PKP). Payer status, ethnic group, age, gender, and geography (urban versus rural) was extracted from each surgical encounter and reconfigured to provide a "clean", congruous dataset for statistical analysis. This Institutional Review Board-approved study did not utilize identifiable patient information; thus, individual informed consent was not required. RESULTS: From 2005-2014, CT (n=28,607) represented less than 1% of the total ambulatory surgeries (n=12,695,932) performed in Florida. EK volume increased while PKP and ALK volume decreased, year-over-year. Statistical significance was found between transplantation technique by sex (P<0.001) and ethnic group (P<0.001). The largest sex discrepancy was EK (59% female, 41% male). White patients underwent relatively fewer PKP than EK (71% vs. 83% of totals), while Black patients underwent relatively more PKP than EK (14% vs 6% of totals). Statistical significance was found between techniques by payer (P<0.001). Medicare was the most common payer for all techniques, but ALK and PKP had higher percentages of private insurance and self-pay. No statistical significance was found between techniques by geographic location. Corneal edema (22.4%), endothelial dystrophy (17.5%), and bullous keratopathy (10.9%) were erroneously coded as indications for ALK. Corneal scars (2.5%) and corneal opacity (1.7%) were erroneously coded as indications for EK. CONCLUSIONS: CT rates in Florida appear to overrepresent the female sex and underrepresent ethnic minorities, with propensities between PKP and African Americans, EK and female patients, and EK and Medicare reimbursement. Our study further confirms the utility of data mining for providing efficient, detailed, and practical insights into ophthalmology procedures, while highlighting the intrinsic challenges of large datasets.

Economic, clinical and social impact of simple limbal epithelial transplantation for limbal stem cell deficiency.

AIMS: To report the global uptake of simple limbal epithelial transplantation (SLET) and compare the economic, clinical and social outcomes of SLET with those of cultured limbal epithelial transplantation (CLET). METHODS: A comprehensive literature review and an online survey of eye surgeons were conducted to understand the efficacy and current uptake of SLET surgery. A de novo economic model was developed to estimate the cost savings with SLET compared with CLET. Our economic analysis is conducted from an Indian perspective, as this is where the technique originated. A scenario analysis using the UK cost data and a user-friendly Excel model is included to allow users to input the costs from their setting to estimate the cost savings with using SLET compared with using CLET RESULTS: The anatomical success with SLET in adults (72.6% (range 62%-80%)) was the same as CLET (70.4% (range 68%-80.9%)). For children, the outcome for SLET (77.8% (range 73%-83%)) was better than with CLET (44.5% (range 43%-45%)). In response to our informal questionnaire, 99 surgeons reported to have performed SLET on 1174 patients in total. They appreciated that SLET negates the requirement for costly tissue engineering facilities. Results of economic analysis suggested that SLET provided an estimated cost-savings of US$6470.88 for adults and US$6673.10 for children. In broad terms, the cost of SLET is approximately 10% of the cost of CLET for adults and 8% for children. CONCLUSION: SLET offers a more accessible and financially attractive alternative to CLET to treat limbal stem cell deficiency.

Assessment of the Role and Timing of Glaucoma Surgery in Boston Keratoprosthesis Type 1 Patients.

PURPOSE: To determine the role and optimal timing of glaucoma surgery in relation to Boston keratoprosthesis type 1 (KPro) implantation. DESIGN: Retrospective, comparative, nonrandomized clinical study. METHODS: Single-center study of a total of 100 eyes (100 patients) implanted with a KPro between 2008 and 2017, and diagnosed with glaucoma before or after KPro. Patients were separated into 2 groups: those with preexisting glaucoma and those who developed de novo glaucoma after KPro. Groups were then divided based on whether patients were medically or surgically managed. Glaucoma surgery included glaucoma drainage device (GDD) implantation, trabeculectomy, and cyclophotocoagulation (CPC). Primary outcomes included best-corrected visual acuity (BCVA), glaucoma progression, and complications. Differences in outcomes were compared using parametric and nonparametric tests, as well as log-rank test to compare time-to-outcome events. RESULTS: Among 72 eyes with preexisting glaucoma, 27 (38%) had glaucoma surgery before KPro (18 GDD), whereas 45 (62%) were medically managed only. Among the latter, 19 (42%) needed glaucoma surgery post-KPro (16 GDD). Among 28 eyes with de novo glaucoma, 12 (43%) had glaucoma surgery post-KPro (9 GDD). For eyes with preexisting glaucoma, glaucoma progression was greater with glaucoma surgery performed post-KPro (100%) compared with pre-KPro (74%, P = .016) and to medical management (54%, P = .002). No increase in complications were observed with glaucoma surgery compared to medications only (P > .05), whereas fewer eyes maintained a BCVA of 20/200 or better over time with medical management (P = .013). Eyes with de novo glaucoma had similar progression, BCVA, and complications between medical and surgical care (P > .05). CONCLUSIONS: Glaucoma surgery should be performed before or at the same time as KPro implantation in eyes with preexisting glaucoma. Complication rates are not increased when glaucoma surgery is performed in KPro eyes with either preexisting or de novo glaucoma. To ensure optimal glaucoma control, glaucoma surgery should be performed as early as possible in KPro eyes with good visual potential.

Comparing ProKera With Amniotic Membrane Transplantation: Indications, Outcomes, and Costs.

PURPOSE: The aim of this study was to compare the outcomes of ProKera versus amniotic membrane transplantation (AMT) in managing ocular surface disease. METHODS: This study is a retrospective case series of patients who received either ProKera or sutured AMT for ocular surface disease. Patient demographics, treatment indications, retention time, percentage healed area, changes in visual acuity, and costs to the health care system were analyzed. RESULTS: Fourteen patients were identified and analyzed for each group. The main indications for using ProKera and AMT were similar, including corneal ulcer or epithelial defect due to chemical burns, neurotropic state, or herpes zoster keratitis. The average time to dissolution or removal was 24.8 days in the ProKera group, compared with 50.1 days in the AMT group. The average percentage of healed corneal area was 59% for ProKera and 73% for AMT. There was no significant difference between the initial and the final visual acuity within groups and when comparing both groups. In our expense analysis, ProKera had a total cost of 699.00 Canadian dollars (CAD), whereas the cost of suture AMT was 1561.52 CAD. ProKera priced at 11.85 CAD for each percentage healed surface area and at 21.39 CAD for AMT. CONCLUSIONS: ProKera allowed for a faster corneal healing than sutured AMT, although its total healed area was less than the latter. Moreover, ProKera is more cost-effective than AMT, thus reducing financial burden to our health care system.

Cost-effectiveness of Descemet stripping automated endothelial keratoplasty versus penetrating keratoplasty in patients with endothelial dysfunction in India.

PURPOSE: The aim of this study was to compare the cost-effectiveness and perform cost-utility analysis of Descemet stripping automated endothelial keratoplasty (DSAEK) vs. penetrating keratoplasty (PK) in Indian population. METHODS: This was an institutional, ambispective, observational study. Patients who underwent PK or DSAEK for endothelial dysfunction were included and followed up for 2 years; those with other ocular comorbidities were excluded. The analysis was performed from the patient's perspective receiving subsidized treatment at a tertiary care hospital. Detailed history, ophthalmic examination, total expenditure by patient, and clinical outcomes were recorded. The main outcome measures were best spectacle-corrected visual acuity (BSCVA), graft survival (Kaplan-Meier survival estimates), incremental cost-effectiveness ratio (ICER), and incremental cost-utility ratio (ICUR). Utility values were based on quality-adjusted life years (QALYs) associated with visual acuity outcomes. Statistical analysis was performed using SPSS software package, version 12.1; a value of P < 0.05 was considered statistically significant. RESULTS: A total of 120 patients (PK: 60, DSAEK: 60) were included. At 2 years, for a similar logMAR BSCVA, [PK (0.32 ± 0.02), DSAEK (0.25 ± 0.02); P = 0.078], the overall cost for PK (13511.1 ± 803.3 INR) was significantly more than DSAEK (11092.9 ± 492.1 INR) (difference = 1952.6 INR; P = 0.01). ICER of DSAEK relative to PK was -39,052 INR for improvement in 1 logMAR unit BSCVA. ICUR of DSAEK relative to PK was -1,95,260 INR for improvement in 1 QALY. CONCLUSION: DSAEK was more cost-effective than PK in patients with endothelial dysfunction at 2 years.

SARS-CoV-2: Impact on, Risk Assessment and Countermeasures in German Eye Banks.

INTRODUCTION: Since the beginning of the COVID-19 pandemic there has been some debate regarding the risk of transmission through tissue transplantation and tissue banking processes. AIM OF THE STUDY: To analyze the changes that SARS-CoV-2 has caused regarding the harvesting of corneal donor tissue and eye bank activities in Germany. METHODS: A questionnaire was provided to 26 eye banks in Germany, consisting of questions about adaptations made in the screening of potential donors and the harvesting of corneal tissue following the pandemic spread of SARS-CoV-2. RESULTS: Eighteen eye banks actively reduced recruitment of donors and two banks ceased all activity. Additional diagnostic screening was performed in eight banks, using conjunctival swabs and/or nasopharyngeal swabs. In six eye banks, additional protective measures, such as FFP2 masks and/or facial shields, were implemented. Overall, a mean reduction in the number of obtained donor tissues of 17% was observed. DISCUSSION: Conjunctival and/or nasopharyngeal swabs of donors have been implemented by a minority. Reasons for not performing additional tests may be moderate sensitivity and lack of validation for postmortem use of RT-PCR testing. Also, the hazard of SARS-CoV-2 entering the corneal donor pool with subsequent transmission might be perceived as theoretical. Face shields provide a sufficient barrier against splash and splatter contamination but may be insufficient against aerosols. Additional face masks would provide support against aerosols, but it remains debatable if corneal harvesting can be considered an aerosol-producing procedure. In the future we expect to see changes in current guidelines because of a surge in scientific activities to improve our understanding of the risks involved with cornea donation in the COVID-19 pandemic, and because current practice may reduce the availability of donor corneas due to new exclusion criteria while the demand remains unchanged.

Corneal Blindness in Asia: A Systematic Review and Meta-Analysis to Identify Challenges and Opportunities.

PURPOSE: To describe the causes and prevalence of moderate-to-severe visual impairment (MSVI) and blindness from corneal diseases, as well as corneal transplantation across Asia. METHODS: A meta-analysis of the published literature to identify population-based surveys conducted from 2008 to 2019 in 22 Asian countries regarding the prevalence and causes of MSVI and blindness from corneal disease, and a review of national corneal transplant data and eye bank statistics. RESULTS: A total of 5307 records were screened to identify 57 reports that were used to estimate a prevalence of MSVI and blindness caused by corneal diseases in Asia of 0.38% (95% confidence interval, 0.29%-0.48%). The most frequent corneal diseases were infectious keratitis, trauma, and pseudophakic bullous keratopathy. As expected, these represented the most common indications for corneal transplantation, although the percentages in each country differed based on the level of economic development, with pseudophakic bullous keratopathy being the most common indication in countries with higher gross national income per capita. Despite this, endothelial keratoplasty is not the most commonly performed form of corneal transplantation in any Asian country and represents only a small percentage of keratoplasty procedures performed in most countries. CONCLUSIONS: The prevalence of MSVI and blindness from corneal disease in Asia is approximately 0.4%, with a nearly 20-fold difference in the national prevalence across the region. The indications for keratoplasty, reflective of the causes of corneal dysfunction, also vary, more so according to the gross national income than to geographic location, and only a few Asian countries have rates of corneal transplantation above international means.

Postoperative Complications in Medicare Beneficiaries Following Endothelial Keratoplasty Surgery.

PURPOSE: To determine national-level incidence rates of major postoperative complications following endothelial keratoplasty (EK) procedures and to stratify these rates based on EK indications over an 8-year period using Medicare claims data. DESIGN: Retrospective, cohort study. METHODS: Setting: population-based; study population: Medicare beneficiaries aged ≥65 years who underwent EK procedures; main outcome measurements: 1) occurrence of major postoperative complications (i.e., endophthalmitis, choroidal hemorrhage, infectious keratitis, cystoid macular edema [CME], retinal detachment [RD], or RD surgery) following EK surgery; 2) time-to-event analysis for glaucoma surgery; and 3) occurrence of graft complications. RESULTS: A total of 94,829 EK procedures (n = 71,040 unique patients) were included in the analysis. Of the total, 29% of patients had pre-existing glaucoma. The overall 90-day cumulative incidence of postoperative endophthalmitis and choroidal hemorrhage following EK was 0.03% and 0.05%, respectively. The overall 1-year cumulative rates of RD or RD surgery, infectious keratitis, and CME were 1.0%, 0.8%, and 4.1%, respectively. Approximately 7.6%, 12.2%, and 13.8% of all eyes in this study needed glaucoma surgery at 1-, 5-, and 8-years of follow-up, respectively. The probability of glaucoma surgery among patients with pre-existing glaucoma was 29% vs. 8% among those without pre-existing glaucoma at 8 years. The cumulative probabilities of developing any graft complications were 13%, 23.2%, and 27.1% at 1, 5, and 8 years, respectively, of follow-up. On average, patients undergoing EK procedures for a prior failed graft had the highest rate of complications, whereas those with Fuchs' corneal endothelial dystrophy had the lowest. CONCLUSIONS: The incidence of major postoperative complications including endophthalmitis, retinal detachment, and choroidal hemorrhage following EK procedures is low. A high proportion of eyes undergoing EK eventually require glaucoma surgery and experience graft-related complications. Postoperative outcomes are typically worse for patients undergoing EK for prior failed grafts than for those undergoing EK for Fuchs' corneal endothelial dystrophy.

Development and Validation of an Open-Source Grading Tool for Outcome Assessment in Limbal Stem Cell Treatment.

PURPOSE: To design a grading system and validate an open-source tool to improve objective quantification and follow-up of limbal stem cell deficiency (LSCD) after treatment. METHODS: A custom-made web-based grading system was developed for grading stem cell deficient eyes, termed the "Vascularisation, Haze, and Integrity" tool. For validation purposes, 60 corneal slit-lamp images of 30 limbal stem cell deficient eyes were graded by 3 groups of examiners: 3 corneal specialists (group A), 3 ophthalmologists with an expertise other than cornea (group B), and 3 nonclinicians (group C). The intragrader and intergrader agreement was evaluated using Fleiss weighted kappa coefficients and concurrent assessment of interrater and intrarater reliability (IRR) coefficients. RESULTS: The overall intergrader agreement was 0.78, 0.61, and 0.42 for superficial corneal vascularization, corneal haze, and epithelial integrity, respectively. All groups had good agreement for the vascularization parameter with the highest intergrader reliability in group A (IRR = 0.80) and the lowest in group C (IRR = 0.72). When assessing "haze," there was good agreement in groups A (IRR = 0.75) and B (IRR = 0.76) but low agreement in group C (IRR = 0.37). CONCLUSIONS: We report the development and evaluation of a novel method for grading results of limbal stem cell deficient eyes after treatment and provide this system as a free, open-source online tool. The grading tool offers an easy and standardized way of assessing the corneal surface in patients with LSCD, enables evaluation of progression over time, reduces assessment bias, and-if adopted universally-will harmonize outcome being reported between groups.

Association of Limiting Opioid Prescriptions With Use of Opioids After Corneal Surgery.

Importance: Opioids, which carry a high risk for addiction and overdose, are commonly prescribed after corneal surgery. Data are lacking describing opioid prescribing practices and opioid needs by patients after ophthalmic surgery. Objectives: To quantify opioid use and to assess the association of decreasing the number of opioid tablets prescribed after corneal surgery with postsurgical use. Design, Setting, and Participants: This prospective cohort study investigated opioid use after corneal surgery using direct interviews of 2 adult patient cohorts separated by an updated opioid prescribing guideline. The first cohort survey assessed the quantity of opioid tablets used after surgery. The cornea division of a tertiary care academic medical center reviewed the use needs and decreased the number of tablets prescribed after routine cases. Simultaneously, a statewide opioid monitoring program began that provided patients with opioid information. A second unique cohort received a more detailed survey to assess use, opioid disposal, and pain control. Data for the first cohort were collected from December 1, 2017, through January 19, 2018; for the second cohort, from June 1 to September 15, 2018. Data were analyzed from October 24, 2018, through September 24, 2019. Exposure: Corneal surgery. Main Outcomes and Measures: Differences in use of opioid tablets used by both patient cohorts, assessed using the 2-sample t test. Results: Of 112 eligible, contacted patients, 82 consented to participate (42 men [51%]; mean [SD] age, 42.5 [17.8] years) and were included in the analysis; 38 of 42 participated in the first cohort and 44 of 70 participated in the second cohort. Of those receiving opioid prescriptions, the first cohort was prescribed significantly more tablets than the second cohort (mean [SD], 18.8 [4.2] vs 6.6 [3.1]; difference, 12.2 [95% CI, 10.4-14.0]; P < .001). The first cohort used significantly more tablets than the second cohort (mean [SD], 8.3 [7.0] vs 4.0 [3.2]; difference, 4.3 [95% CI, 1.4-7.2]; P = .005) and had significantly more leftover tablets (mean [SD], 10.3 [6.9] vs 2.9 [2.7]; difference, 7.5 [95% CI, 4.7-10.2]; P < .001). In the detailed survey for the second cohort, 19 of 27 patients reported pain control as adequate (70% [95% CI, 50%-86%]); 6 of 27, as more than needed (22% [95% CI, 9%-42%]). Twenty of 28 participants (71% [95% CI, 55%-88%]) had leftover tablets; 17 of these (85% [95% CI, 62%-97%]) did not dispose of leftovers, and 3 (15% [95% CI, 3%-38%]) threw away or flushed leftovers. Conclusions and Relevance: After an assessment of opioid needs, physicians prescribed fewer opioid pills. However, patients who underwent cornea surgery and received fewer tablets continued to have adequate pain control and used even fewer tablets compared with the initial cohort. Patients with unused opioid tablets did not dispose of them properly.

Eye donation in north India: Trends, awareness, influences and barriers.

Purpose: To understand trends, awareness, influences and barriers to eye donation in Indian society. Methods: This cross sectional study was conducted in Delhi from March 2017 to February 2018. About 10 hospitals collaborated with the Eye Bank under Human Cornea Retrieval Program (HCRP). Eye Bank recruited Eye Donation Counselors (EDCs) to approach family members of the deceased. A pretested questionnaire was used for this study. Irrespective of whether the next of kin of the deceased consented for eye donation or not, the option of participating in the survey was given. Results: Out of 473 potential donors identified, 407 (86%) next of kin consented to participate in the study. Of these, 388 (95.3%) were males and 19 (4.7%) were females. About 168 (41%) consented for eye donation and were assigned to donor group, while 239 (59%) participants refused eye donation and were assigned to non-donor group. Majority of the participants were siblings 170 (41.8%) of the deceased and the mean age of the deceased was 42.71 ± 17.56 years. The foremost concern before decision-making was transparency in how the cornea would be used (32.25%). The concern with regards to whether the body would remain intact after eye donation significantly decreased the probability of consent for eye donation. Conclusion: The study highlights that barriers to eye donation in India are not cultural or religious but more due to misinformation and proper utilization of the donated tissue. This study also emphasizes the pivotal role of EDC's in facilitating the eye donation movement.

Descemet Membrane Endothelial Keratoplasty Outcomes During the Initial Learning Curve of Cornea Fellows.

PURPOSE: To describe the outcomes of Descemet membrane endothelial keratoplasty (DMEK) performed by cornea fellows during their initial learning curve. METHODS: This prospective study included the first consecutive series of 53 DMEK surgeries performed by 14 corneal fellows at Sorocaba's Ophthalmological Hospital. Best spectacle-corrected visual acuity, endothelial cell density (ECD), and complications were evaluated. RESULTS: Of the eyes without ocular comorbidities and with complete visual acuity measurements, 97% of 33 eyes achieved a best spectacle-corrected visual acuity of ≥20/40 in 6 months. The mean (SD) preoperative donor ECD was 2453 (361) cells/mm, and at 6 months postoperatively, the in vivo mean ECD (SD) was found to be 1300 (587) cells/mm, an average loss of 47%. Preparation of the DMEK graft by the cornea fellows was successful in all cases. There were 9 eyes (17%) that experienced partial graft detachment requiring rebubbling. A total of 3 eyes (5.7%) failed to clear the cornea, all of which were managed with successful secondary endothelial keratoplasty. None of the eyes experienced pupillary block. CONCLUSIONS: Establishing DMEK in a fellowship program was successful with the supervision of an experienced DMEK surgeon. Even without the facility of a prestripped DMEK graft by an eye bank and with no backup tissue, no surgery was canceled because of graft preparation failure. Good visual outcomes were achieved with satisfactory ECD at 6-month follow-up, with an acceptable complication rate. Even the 3 eyes that failed to clear the cornea evolved well after secondary endothelial keratoplasty by the cornea fellows.

Lucia and Beyond: Development of an Affordable Keratoprosthesis.

PURPOSE: Severe corneal disease contributes significantly to the global burden of blindness. Corneal allograft surgery remains the most commonly used treatment, but does not succeed long term in every patient, and the odds of success fall with each repeated graft. The Boston keratoprosthesis type I has emerged as an alternative to repeat corneal allograft. However, cost limits its use in resource-poor settings, where most corneal blind individuals reside. METHODS: All aspects of the Boston keratoprosthesis design process were examined to determine areas of potential modification and simplification, with dual goals to reduce cost and improve the cosmetic appearance of the device in situ. RESULTS: Minor modifications in component design simplified keratoprosthesis manufacturing. Proportional machinist time could be further reduced by adopting a single axial length for aphakic eyes, and a single back plate diameter. The cosmetic appearance was improved by changing the shape of the back plate holes from round to radial, with a petaloid appearance, and by anodization of back plate titanium to impute a more natural color. CONCLUSIONS: We have developed a modified Boston keratoprosthesis type I, which we call the "Lucia." The Lucia retains the 2 piece design and ease of assembly of the predicate device, but would allow for manufacturing at a reduced cost. Its appearance should prove more acceptable to implanted patients. Successful keratoprosthesis outcomes require daily medications for the life of the patient and rigorous, frequent, postoperative care. Effective implementation of the device in resource-poor settings will require further innovations in eye care delivery.

Synthetic biodegradable alternatives to the use of the amniotic membrane for corneal regeneration: assessment of local and systemic toxicity in rabbits.

AIM: The aim of this study was to assess the local and systemic response to poly-lactic co-glycolic acid (PLGA) 50:50 membranes, developed as synthetic biodegradable alternatives to the use of human donor amniotic membrane in the treatment of limbal stem cell deficiency. METHODS: PLGA membranes of 2 cm diameter and 50 µm thickness were placed on one eye of rabbits and secured in place using fibrin glue and a bandage contact lens, suturing the eye close with a single stitch. Control animals were treated identically, with the absence of the membranes. Plain and microfabricated electrospun membranes (containing micropockets which roughly emulate the native limbal niche) were examined over 29 days. All animals were subjected to a detailed gross and histopathological observation as well as a detailed examination of the eye. RESULTS: Application of the membranes both with and without microfabricated pockets did not adversely affect animal welfare. There was complete degradation of the membranes by day 29. The membranes did not induce any significant local or systemic toxicity. Conjunctival congestion and corneal vascularisation were noted in a few control and PLGA-treated animals. Intraocular pressure was normal and the retinal status was unaltered. The ocular surface was clear and intact in all animals by the end of 29 days. CONCLUSION: Membranes of 50:50 PLGA can be safely applied to rabbit corneas without inducing any local or systemic toxicity and these break down completely within 29 days.

Risk of Glaucoma Surgery After Corneal Transplant Surgery in Medicare Patients.

PURPOSE: Glaucoma is a well-documented complication of corneal transplants, contributing significantly to ultimate visual loss. Reported incidence of glaucoma following corneal transplants is highly variable, and definitions of posttransplant glaucoma are inconsistent. Here we use glaucoma surgery as a more rigid and specific endpoint to compare rates following different corneal transplant surgeries. DESIGN: Retrospective cohort study. METHODS: A 5% random sample of Medicare beneficiaries from 2010-2013 was obtained and patients were identified with Current Procedural Terminology (CPT) codes for penetrating keratoplasty (PK), endothelial keratoplasty (EK), anterior lamellar keratoplasty (ALK), and keratoprosthesis (KPro). Rates of glaucoma surgery within the same year following the abovementioned corneal transplants were analyzed. Subgroup analyses included patients who carried preexisting glaucoma diagnoses prior to corneal transplant surgery. RESULTS: There were 3098 patients who underwent corneal transplants during the study period, including 1919 EK, 1012 PK, 46 ALK, 32 KPro, and 89 both PK and EK. Rates of glaucoma surgery ranged from 6.1% to 9.4% in the corneal transplant groups, without statistically significant differences among groups. However, 10.0% of patients with preexisting glaucoma required glaucoma surgery following any transplant surgery, compared with 5.3% of patients without preexisting glaucoma. This included 12.4% of PK patients with preexisting glaucoma compared with 2.8% of PK patients without preexisting glaucoma (P < .01). CONCLUSIONS: Despite literature suggesting that more angle-altering cornea surgeries confer higher risk, we found no statistically significant differences among various transplant groups. Patients with preexisting glaucoma, however, had higher risk of glaucoma surgery within the same year following corneal transplant surgery, which was especially pronounced in the PK group. These patients require special care when considering long-term effects of corneal transplants.