Purpose:The purpose of this study was to evaluate clinical factors that could differentiate patients with Sjogren's disease-related dry eye (SDDE) from non-SDDE. Methods:Patients with SDDE (n = 20), non-SDDE (n = 47), and healthy control participants (n = 29) were enrolled. Patients with dry eye were required to have physician-diagnosed dry eye disease for at least 6 months prior to the study. Sjogren's diagnosis was made according to 2016 Sjogren's disease criteria. Control participants had no known dry eye diagnosis or ocular and/or autoimmune disease. Several validated questionnaires regarding overall health and perception of health, mental status, review of systems, and ocular symptom were administered concurrently. Ocular surface and tear film parameters were evaluated using strict methodology. Results:Each questionnaire, each section within a questionnaire, and each question within a section were evaluated. Of systemic symptom questionnaires, only Profile of Fatigue and Discomfort Questionnaire (PROFAD) differentiated between SDDE and non-SDDE (10.5 vs. 5.8, P = 0.003). Among four Sjogren's Foundation recommended review of systems questions, only dry mouth differentiated patients with SDDE from non-SDDE (90% vs. 53%, P = 0.004). No mental health or ocular symptom questionnaires were different between SDDE versus non-SDDE. Among clinician-measured ocular surface parameters, only corneal fluorescein (2.5 vs. 1.0, P = 0.006) and conjunctival lissamine green (2.0 vs. 1.0, P = 0.001) staining scores were significantly worse in patients with SDDE compared to non-SDDE. Conclusions:Ocular staining and dry mouth complaints were strongly associated with SDDE. Translational Relevance:Ocular surface vital dye staining and inquiring about dry mouth complaints can be helpful to determine whether Sjogren's laboratory work-up should be considered in patients presenting with dry eye disease.

PURPOSE:To identify risk factors for the development of uveitis and CME after cataract surgery. METHODS:Medicare patients with no known history of uveitis receiving cataract surgery between 2012 and 2015 (n = 146,536) were identified from a 5% nationwide sample of Medicare beneficiaries. Multivariable regression assessed the association between demographic factors, history of rheumatic, ocular, and systemic disease, and prior ocular procedures with the risks of postoperative anterior uveitis, panuveitis, posterior uveitis, and CME. RESULTS:Black patients had higher odds of developing anterior uveitis (OR 4.58, 95% CI [4.01-5.22]) and CME (OR 1.70, 95% CI [1.48-1.93]) compared to White patients. Patients with primary open angle glaucoma (OR 1.66, 95% CI [1.43-1.91]) and CME (OR 1.18, 95% CI [1.04-1.33]) and closed angle glaucoma had higher odds of developing anterior uveitis (OR 1.57, 95% CI [1.14-2.10]) and CME (OR 1.37, 95% CI [1.04-1.78]). Patients with a history of retinal detachment repair had higher odds of developing posterior uveitis (OR 20.42, 95% CI [1.53-119.28]) and CME (OR 2.01, 95% CI [1.25-3.20]). Patients with a history of vitrectomy had higher odds of developing posterior uveitis (OR 6.02, 95% CI [1.24-19.80]) and CME (OR 4.43, 95% CI [3.64-5.36]). CONCLUSION:Black race, open and closed angle glaucoma, and a history of retinal detachment repair and vitrectomy were risk factors for developing uveitis and CME after cataract surgery. These findings should inform postoperative management approaches for at-risk populations.

PURPOSE:To evaluate whether dry eye disease (DED) diagnosis may increase the subsequent risk of developing depression and anxiety. METHODS:In this retrospective cohort study, Medicare beneficiaries aged 65 and older with a new diagnosis of DED, no prior history of depression and/or anxiety disorder, and continuous follow-up between 2011 and 2015 were identified from a 5% random sample of nationwide Medicare claims. Beneficiaries included in the DED cohort were matched to a non-DED cohort at a 1:4 ratio using propensity scores based on demographic factors and systemic comorbidities. Crude incidence rates and rate ratios for depression and anxiety were calculated. Multivariable Cox proportional hazards regression model was fit to evaluate the impact of demographic factors and dry eye on the risk of developing these conditions while adjusting for systemic comorbidities. MAIN OUTCOME MEASURES:Longitudinal incidence of depression and anxiety in DED versus non-DED groups. RESULTS:The unadjusted incidence of depression was 30% higher [incidence rate ratio 1.30, 95% confidence interval (CI), 1.24‒1.36] in the DED cohort, and the unadjusted incidence of anxiety was 50% higher (incidence rate ratio 1.50, 95% CI, 1.41-1.58) compared with the non-DED group. The increased susceptibility to depression (adjusted hazard ratio 1.25, 95% CI, 1.19-1.31) and anxiety (adjusted hazard ratio 1.45, 95% CI, 1.37-1.54) because of DED remained significant after adjusting for demographic factors and systemic comorbidities. CONCLUSIONS:DED is an independent risk factor for developing depression and anxiety in the elderly.

OBJECTIVE:There is currently no systematic method of assessing limitations in performing corneal transplantation. The purpose of the study was to identify the limitations of performing corneal transplantation in India. DESIGN:Cross-sectional survey study. PARTICIPANTS:A total of 148 members of the Cornea Society of India. METHODS:A survey tool was developed to identify region-specific barriers to performing corneal transplantation. The survey was edited by a marketing firm and reviewed and approved by 4 of the participating corneal surgeons in India. The electronic survey was distributed nationwide to members of the Cornea Society of India between January 1, 2021 and July 1, 2021. Participants were asked to rate the difficulty or ease of 11 predetermined steps/variables of the corneal transplantation process using a Likert scale. RESULTS:One hundred forty-eight practicing cornea surgeons participated in the survey (21% response rate). The most common barrier was difficulty with finding donors who fulfilled the screening criteria for transplantation (55%). The second most common barrier was patient/family willingness to donate organs (32%). The third most common barrier was the inability to store tissue after it was prepared by the eye bank (20%). The two variables least commonly identified as barriers were operating room staff availability and using the donor tissue before expiration. CONCLUSION:The greatest barrier to corneal transplantation in India was finding donors who fulfilled screening criteria. Additional studies into the contributing factors are underway to inform governing bodies on resource allocation to enhance procurement of quality donor tissues.

PURPOSE:There is a lack of research on the extent to which non-Sjögren collagen vascular diseases affect the ocular surface. This study aims to understand the associations between collagen vascular diseases and dry eye and corneal ulcers. METHODS:This study analyzed a random 5% sample of national Medicare beneficiaries from 2011 to 2015 and included claims for those with collagen vascular diseases and either dry eye or corneal ulcers (n = 2,688,114). Two multivariable logistic regression models assessed the outcomes of dry eye and corneal ulceration, considering age, sex, race, and collagen vascular diseases as exposure variables. RESULTS:A total of 219,352 patients with dry eye and 4366 patients with corneal ulcer were identified. Various collagen vascular diseases exhibited distinct associations with dry eye (primary Sjögren's: [odds ratio (OR) 9.67], [95% confidence interval (CI) = 9.06 to 10.31]; secondary Sjögren's: OR 3.92, 95% CI = 3.64 to 4.21; rheumatoid arthritis: OR 2.43, 95% CI = 2.37 to 2.48; systemic sclerosis: OR 2.12, 95% CI = 1.91 to 2.36). Corneal ulcers also had an association with rheumatologic diseases (primary Sjögren's: OR 6.26, 95% CI = 4.48-8.47; secondary Sjögren's: OR 3.59, 95% CI = 2.63-4.81; rheumatoid arthritis: OR 3.34, 95% CI = 2.95-3.76; psoriatic arthritis: OR 1.64, 95% CI = 1.01-2.49). CONCLUSIONS:The strong association between collagen vascular disease and dry eye and corneal ulcers necessitates an interdisciplinary approach with close collaboration between rheumatologists and ophthalmologists in the diagnosis and management of systemic inflammatory diseases.

Purpose:The purpose of this study was to assess the utility of artificial intelligence (AI) assisted analysis of anterior segment optical coherence tomography (AS-OCT) imaging of the device-cornea joint in predicting outcomes of an intrastromal synthetic cornea device in a rabbit model. Methods:Sixteen rabbits underwent intrastromal synthetic cornea implantation. Baseline anterior lamellar thickness was established using AS-OCT intraoperatively. Monthly postoperative clinical examinations and AS-OCT imaging were performed, focusing on the peri-optic zone. A convolutional neural network was trained using a subset of manually marked images to automatically detect anterior lamellar tissue. Images were aligned manually using reference coordinates. The tissue volume data were evaluated as both absolute volume and percentage change from baseline using AI. Results:Sixteen rabbits were observed for 6 (n = 8) and 12 (n = 8) months. Mild focal anterior lamella thinning without retraction was seen near tight sutures in 2 rabbits (2/8) in the 6-month cohort, whereas 2 rabbits (2/8) in the 12-month cohort showed mild focal retraction from the optic stem with thinning. AI-assisted AS-OCT image analyses detected tissue volume reduction up to 3 months before clinical examination, with a reliable threshold of 5% change in tissue volume. Conclusions:AI-assisted AS-OCT can detect peri-prosthetic tissue loss and predicting postoperative complications following an intrastromal synthetic cornea implantation in a rabbit model. Further studies are warranted to explore its clinical utility in human patients. Translational Relevance:AI-assisted monitoring of peri-optic corneal tissue volume may be a useful screening modality to detect subclinical thinning after artificial corneal implantation and inform clinical decision making.

Corneal disease ranks as the fifth leading cause of global blindness, affecting more than 10 million individuals. Donor corneal transplantation, keratoplasty, remains the mainstay of addressing loss of corneal clarity. Historically, full-thickness penetrating keratoplasty (PK) has been one of the most successful and widely performed transplant procedures, although predominantly available in developed countries. The landscape for corneal transplantation has changed dramatically over the last two decades with the emergence of partial-thickness transplantation techniques and corneal cross-linking, which provide less invasive means of treating diseases like Fuchs' dystrophy and keratoconus, respectively. Currently, PK is often performed in eyes with complex problems and at high risk of graft failure. In fact, repeat grafting has become the second most common indication for PK. Furthermore, a significant shortage of donor corneas persists, with half of the global population lacking access to tissues. This shortage is particularly pronounced in developing countries, which lack the necessary infrastructure to support corneal transplantation despite bearing the highest burden of corneal blindness. Artificial corneal devices, known as keratoprostheses, have been posited as a remedy for various constraints of conventional keratoplasty and have demonstrated promising outcomes, particularly in high-risk cases. Synthetic devices are not subject to the risk of allograft rejection or endothelial failure. In resource-limited areas, keratoprostheses could potentially replace donor keratoplasty by eliminating the costly eye banking system to access, preserve and distribute the short-lived fresh donor tissues. Herein, we report the design, surgical technique, indications and early outcomes of clinical-stage fully synthetic keratoprostheses currently undergoing trials globally.

Purpose: We sought to introduce the materials, design, and biocompatibility of a flexible and suturable artificial corneal device. Methods: Single-piece, fully synthetic, optic-skirt design devices were made from compact perfluoroalkoxy alkane. The skirt and the optic wall surfaces were lined with a porous tissue ingrowth material using expanded polytetrafluoroethylene. Full-thickness macroapertures around the skirt perimeter were placed to facilitate nutrition of the recipient cornea. Material properties including the skirt's modulus of elasticity and bending stiffness, optic light transmission, wetting behavior, topical drug penetrance, and degradation profile were evaluated. Results: The final prototype suitable for human use has a transparent optic with a diameter of 4.60 mm anteriorly, 4.28 mm posteriorly, and a skirt outer diameter of 6.8 mm. The biomechanical and optical properties of the device closely align with the native human cornea with an average normalized device skirt-bending stiffness of 4.7 kPamm4 and light transmission in the visible spectrum ranging between 92% and 96%. No optical damage was seen in the 36 devices tested in fouling experiments. No significant difference was observed in topical drug penetrance into the anterior chamber of the device implanted eye compared with the na & iuml;ve rabbit eye. Conclusions: The flexibility and biocompatibility of our artificial cornea device may offer enhanced tissue integration and decreased inflammation, leading to improved retention compared with rigid keratoprosthesis designs.

PURPOSE:To evaluate a commercially available dexamethasone intracanalicular insert to treat dry eye. DESIGN:Single-center, double-masked randomized controlled trial. PARTICIPANTS:Patients with clinically significant aqueous-deficient dry eye (combined ocular surface staining score, ≥ 3 [0-12]; corneal fluorescein staining score, ≥ 2 [0-6]; and Schirmer's wetting, < 10 mm at 5 minutes in both eyes) with symptoms (dryness, eye discomfort, or visual fatigue, ≥ 30 [0-100]) despite treatment with at least 1 prescription drop and deemed candidates for topical steroid therapy. METHODS:Seventy-five adult patients were enrolled. A 1:1 randomization sequence was used to determine which eye of each patient would receive the treatment (dexamethasone 0.4-mg intracanalicular insert with 30-day elution time) or sham (collagen plug). The fellow eye received the opposite treatment. Patients were masked to treatment assignment. Follow-up visits (at weeks 2, 4, and 6) were performed by a masked investigator. MAIN OUTCOME MEASURES:Dry eye parameters and patient symptoms were used for efficacy, and intraocular pressure (IOP) was used for safety assessment. RESULTS:The severity of dry eye was comparable between the treatment arms (fellow eyes) at baseline. Eyes that received the dexamethasone insert showed significantly less corneal staining at week 4 (mean difference [MD], -0.55; 95% confidence interval [CI], -0.91 to -0.19) and conjunctival staining at week 4 (MD, -0.68; 95% CI, -1.05 to -0.30) and week 6 (MD, -0.34; 95% CI, -0.65 to -0.02). Schirmer's wetting was comparable between the two treatment arms. Although the patients reported less dryness in eyes that received the insert at week 4 (MD, -5.5; 95% CI, -11.4 to 0.4), no statistically significant differences were found in any patient-reported symptoms. At week 4, dexamethasone-treated eyes were more likely to show an IOP increase (by 5-10 mmHg; 9 eyes vs. 1 eye; relative risk, 9.00; 95% CI, 1.14-71.0). All cases of increased IOP were managed with short-term topical β-blockers and subsided. CONCLUSIONS:The dexamethasone intracanalicular insert may be considered a dropless dual treatment for clinically significant aqueous-deficient dry eye when topical steroid treatment is deemed appropriate. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

PURPOSE:To identify risk factors associated with the development of corneal edema (CE) and the need for corneal transplantation following cataract surgery. DESIGN:Retrospective cohort study. METHODS SETTING:Nation-wide sample of Medicare beneficiaries from 2011-2015. STUDY POPULATION:Medicare beneficiaries aged over 65 years who received cataract surgery between 2011-2014 with at least 1 year of continuous follow-up. Data was retrieved from the Denominator and Physician Supplier Part B file from the Center for Medicare and Medicaid Services. MAIN OUTCOME(S) AND MEASURE(S):The main outcome was the association between demographic characteristics (e.g., age, sex, race/ethnicity) and systemic factors including diabetes status, hypertension, and tobacco use on the incidence of CE and the subsequent need for corneal transplantation following cataract surgery. RESULTS:Among 187,746 beneficiaries, 67,734 had diabetes and 120,012 did not. Beneficiaries with diabetes were more likely to develop CE compared to those without (Odds ratio [OR] 1.19, 95% Confidence Interval [CI] [1.02-1.40]). Compared to those aged 65-74, beneficiaries aged 75-84 and over 85 were more likely to develop CE (OR 1.29 [1.09-1.52]) and OR 1.96 [1.55-2.46], respectively). Asian (OR 2.42 [1.66-3.40]), Hispanic (OR 2.60 [1.73-3.74]), and North American Native (OR 3.59 [1.78-6.39]) race was associated with increased likelihood of developing CE. North American Native beneficiaries had higher risk of requiring corneal transplantation compared to White beneficiaries (OR 9.30 [2.26-25.31]). Female sex decreased likelihood of requiring corneal transplantation post-operatively (OR 0.56 [0.36-0.87]). Amongst those with diabetes, the presence of proliferative diabetic retinopathy increased the likelihood of developing CE (OR 1.94 [1.05-3.39]). CONCLUSION:Older age, diabetes, and non-White race elevate the risk of CE following cataract surgery, with race incurring the highest risk. Further research is needed to understand the factors underlying the significantly increased risk of CE in racial and ethnic minorities within the United States.

Purpose:The purpose of this study was to investigate the impact of demographic characteristics and psychiatric comorbidity on the prevalence of dry eye disease in the American geriatric population.Methods:Data were collected from a 2011 nationwide sample of Medicare beneficiaries aged 65 years and older (N = 1,321,000). Age, sex, race/ethnicity, residential area, climate region, and income, along with psychiatric comorbidities including depression and anxiety, were collected. Multivariable logistic regression models were used to assess the relationship between demographic and psychiatric factors and the prevalence of dry eye disease.Results:Among 21,059 patients with clinically significant dry eye, women had higher odds of having dry eye compared with men [odds ratio (OR) 2.03, 95% confidence interval (1.97-2.10)]. Asian and Native American patients had increased odds of having dry eye compared with White patients [OR 1.85 (1.69-2.02) and OR 1.51 (1.19-1.93)], while Black patients were less likely to have dry eye [OR 0.83 (0.79-0.87)]. Patients aged 75 to 84 years and 85+ were more likely to have dry eye compared with those aged 65 to 74 years [OR 1.49 (0.45-1.53) and OR 1.54 (1.48-1.60)]. Having both depression and anxiety were associated with higher odds of having dry eye [OR 2.38 (2.22-2.55)] compared with having depression alone [OR 1.95 (1.86-2.04)] or anxiety alone [OR 2.22 (2.10-2.35)].Conclusions:Significant racial and regional disparities in dry eye prevalence were found. Psychiatric association with dry eye varied with age, sex, race, and residence region. Further research is needed to comprehend the underlying mechanisms, implications, and to address disparities in the diagnosis and management of dry eye.

OBJECTIVE:To assess the feasibility of using artificial intelligence (AI) to improve readability of online cataract surgery patient education materials (PEMs) in English and Spanish. PARTICIPANTS:Websites with information dedicated to educating patients about cataract surgery. DESIGN:Comparative cross-sectional study. METHODS:The first 50 patient-oriented websites containing PEMs related to cataract surgery were identified through online search. Website authorship was categorized as an institution, private practice, or medical organization. Websites were assessed qualitatively for information accuracy, the presence of narrative video content, and multilingual availability. Readability of PEMs was assessed using five validated reading formulas. A natural language processing platform was used to simplify PEMs in English and Spanish. Converted PEMs were reassessed for readability and accuracy. RESULTS:A total of 32 institution, 7 private practice, and 11 medical organization sites were included. The overall average original reading grade level was 11.68 ± 1.59. After conversion, overall reading grade level improved to 7.94 ± 0.82 (p < 0.01). The first 10 results had better readability (10.40 ± 1.59) and reading ease (57.51 ± 9.24) compared to the subsequent 40 results (11.99 ± 1.43; p = 0.01; 47.64 ± 8.59; p < 0.01). Converted simplified Spanish text had an average reading ease score of 61.17 ± 5.39 (8-9th grade level). Native Spanish text reading ease improved from 57.41 ± 5.24 to 71.78 ± 5.24 (p < 0.01) following conversion (7th-grade level). CONCLUSION:AI conversion can enhance the readability of online PEMs on cataract surgery, while maintaining accuracy and content integrity, thereby improving accessibility and comprehensibility for a wider audience.

Purpose: In Descemet membrane endothelial keratoplasty (DMEK), some patients cannot adhere to postoperative positioning requirements or lack anatomic support for a gas bubble in the anterior chamber. We describe a suturing technique that stabilizes the graft postoperatively without tearing or tenting it. Methods: One to two 10-0 nylon sutures with a spatulated needle are used to secure DMEK grafts. Tied with minimal tension, the sutures traverse the corneal stroma at a steep, almost perpendicular angle and approach the graft from the limbus at an angle tangential to the circular graft to prevent vaulting the tissue off the central cornea. We report preoperative and postoperative best spectacle-corrected visual acuity, corneal pachymetry, and anterior segment optical coherence tomography confirming graft attachment in 3 patients. Results: In case 1 (aphakia, postvitrectomy, and positioning difficulty), pachymetry decreased from 637 μm preoperatively to 495 μm and best spectacle-corrected visual acuity improved from 20/70 to 20/50 at postoperative week 1. In case 2 (aphakia, limited follow-up, and medication adherence), pachymetry decreased from 1106 μm preoperatively to 783 μm at postoperative month 1. In case 3 (tube shunt and loss of gas bubble at 2 hours), slit-lamp examination at postoperative day 1 showed corneal clearing and graft attachment. Pachymetry decreased from over 795 μm preoperatively to 582 μm at postoperative month 1. Anterior segment optical coherence tomography confirmed graft attachment in all patients. Conclusions: Single or opposing tangentially oriented sutures can be safely applied to secure DMEK grafts postoperatively in challenging cases.