PURPOSE:To evaluate the current indications and clinical outcomes for penetrating keratoplasty (PK) in the United States. DESIGN:Retrospective cohort study. PARTICIPANTS:Patients from the IRIS® Registry (Intelligent Research in Sight) without a history of prior keratoplasty who underwent PK from October 2015 through December 2017. METHODS:Corneal graft survival, transplant-specific outcomes, and postoperative complications were evaluated for all patients based on International Classification of Diseases codes. Postoperative graft survival and best-corrected visual acuity (BCVA) were stratified by reported presumed surgical indication. Risk factors for corneal graft failure were evaluated using multivariable analysis. MAIN OUTCOME MEASURES:Postoperative graft survival and BCVA. RESULTS:A total of 4061 patients were included (mean age at surgery, 60.2 years; 51.5% female; 60.6% White). At 5 years, the highest probability of graft failure was observed in patients with complications of ocular prosthetic device (42.9%), trauma or perforation (31.4%), and corneal edema (23.2%), whereas the lowest probability was seen in patients with corneal ectasia (8.5%). Overall graft survival probability at 5 years was 81.1%. Among surgical indications, the highest probability of visual acuity worse than 20/70 was seen in patients with corneal edema (91.3%), corneal opacities (90.9%), and trauma or perforation (87.1%), and the lowest probability was seen in patients with corneal ectasia (67.2%). Half of all patients (53.4%) showed improved BCVA of more than 2 lines after 3 years. CONCLUSIONS:Compared with previous literature, PK was less frequently performed for corneal ectasiae in this study. Although PK in patients with corneal ectasia was associated with increased graft survival and better long-term BCVA compared with other surgical indications in this study, worse outcomes including lower overall graft survival were observed compared with previous literature outcomes for corneal ectasia. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
PURPOSE:To describe the outcome measures, metrics used, and clinical results reported in regulatory trials of the US Food and Drug Administration-approved therapeutics for the treatment of dry eye disease. METHODS:For each trial, data were extracted regarding study design, interventions, and physician-measured clinical outcomes related to ocular surface (corneal and conjunctival vital dye staining score) and tear film (tear production and tear stability) parameters. Main outcome measures details of clinical assessment methods and characteristics of trial patients. RESULTS:Results from 19 trials were included. Reported efficacy end points varied considerably and included Schirmer test, performed with or without topical anesthesia, and analyzed using 2 distinct metrics: mean change from baseline at the final study visit, or responder analyses defined as the proportion of participants achieving a ≥10-mm increase from baseline. Measures of tear film stability were assessed using fluorescein tear film break-up time, with outcomes reported as mean change from baseline in seconds. Ocular surface damage was evaluated through corneal and conjunctival vital dye staining, using 4 different corneal and 3 different conjunctival grading scales, with results expressed as mean change from baseline in total staining scores. Some studies reported corneal staining responder analyses, defined as the proportion of participants achieving a ≥3-grade improvement from baseline. CONCLUSIONS:Heterogeneity among the included studies hindered direct cross-study comparisons, resulting in few meaningful cross-medication comparisons. This review underscores the need for validated, clinically meaningful dry eye disease outcome measures and standardized trial methodologies to advance therapeutic development and facilitate robust cross-study comparisons.
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.
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.
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:To assess the web accessibility and readability of patient-oriented educational websites for cataract surgery. DESIGN:Cross-sectional electronic survey. PARTICIPANTS:Websites with information dedicated to educating patients about cataract surgery. METHODS:An incognito search for "cataract surgery" was performed using a popular search engine. The top 100 patient-oriented cataract surgery websites that came up were included and categorized as institutional, private practice, or medical organization according to authorship. Each site was assessed for readability using 4 standardized reading grade-level formulas. Accessibility was assessed through multilingual availability, accessibility menu availability, complementary educational video availability, and conformance and adherence to the Web Content Accessibility Guidelines (WCAG) 2.0. A standard t test and chi-square analysis were performed to assess the significance of differences with regard to readability and accessibility among the 3 authorship categories. MAIN OUTCOME MEASURES:The main outcome measures were the website's average reading grade level, number of accessibility violations, multilingual availability, accessibility menu availability, complementary educational video availability, accessibility conformance level, and violation of the perceivable, operable, understandable, and robust (POUR) principles according to the WCAG 2.0. RESULTS:A total of 32, 55, and 13 sites were affiliated with institutions, private practice, and other medical organizations, respectively. The overall mean reading grade was 11.8 ± 1.6, with higher reading levels observed in private practice websites compared with institutions and medical organizations combined (12.1 vs. 11.4; P = 0.03). Fewer private practice websites had multiple language options compared with institutional and medical organization websites combined (5.5% vs. 20.0%; P = 0.03). More private practice websites had accessibility menus than institutions and medical organizations combined (27.3% vs. 8.9%; P = 0.038). The overall mean number of WCAG 2.0 POUR principle violations was 17.1 ± 23.1 with no significant difference among groups. Eighty-five percent of websites violated the perceivable principle. CONCLUSIONS:Available patient-oriented online information for cataract surgery may not be comprehensible to the general public. Readability and accessibility aspects should be considered when designing these resources. FINANCIAL DISCLOSURE(S):The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Purpose To investigate health disparities in racial and ethnic minorities with dry eye. Methods Medical records were reviewed for demographics, socioeconomic factors, treatments, and objective dry eye parameters. Race/ethnicity was self-reported as delineated by the U.S. Census. The reference group comprised of randomly selected White patients, with number equal to the largest minority group. Results The study included 465 patients (157 Black, 157 White, 85 Asian, and 66 Hispanic). Compared to White (3.2%) patients, larger proportion of minorities used Medicaid or lacked health insurance (Black 8.3%, P = .054; Asian 10.6%, P = .019; Hispanic 18.2%, P < .001). Black and Hispanic patients had lower estimated median household income than Whites (White $98,472, Black $75,554, P < .001; Asian $105,503, P = .088; Hispanic $86,839, P = .030). Prior to presentation, fewer minority patients received prescription treatments or procedures (White 61.8%; Black 30.6%, P < .001; Asian 43.5%, P = .006; Hispanic 43.9%, P = .014). Although at baseline visit minorities had worse mean conjunctival (White, 1.7; Black 2.2, P = .136, Asian 2.4, P = .022; Hispanic 2.6, P = .005) and corneal staining scores (White, 1.6; Black 2.5, P < .001; Asian 2.3, P = .003; Hispanic 2.4, P = .001), no differences were noted at final visit. Conclusion Minorities presented with worse objective dry eye parameters, and less prior dry eye care. Income and health care access may not fully explain the observed undertreatment at presentation. Differential management by eye care providers and patient attitudes warrant further investigation.
PURPOSE:To report the heterogeneity in methodology of clinical trials submitted to the US Food and Drug Administration (FDA) for approval of topical dry eye treatments. DESIGN:Comparative analysis of clinical trials' methods. METHODS:We reviewed the online, publicly available FDA database, application review files, ClinicalTrials.gov registry records, and journal articles for each FDA-approved topical dry eye treatment. For each trial, we extracted information about the study, patient demographics, treatment names and doses, sample size in each arm, and the measurement instrument in a systematic fashion. RESULTS:Fourteen trials were included that assessed 5 topical treatments for dry eye (cyclosporine 0.05%, cyclosporine 0.09%, lifitegrast 5%, and loteprednol 0.25% eye drops and varenicline 0.03-mg nasal spray). Median treatment duration was 12 weeks (range, 2-24 weeks). In all trials, treatments, including varying concentrations of the same treatment, were compared with vehicle. Twelve trials (85.7%) evaluated a primary clinician-measured clinical sign, and 10 trials (71.4%) evaluated a primary patient-reported symptom. Corneal staining was the most frequently evaluated clinical sign primary outcome, reported in half (6 of 12) of the trials, and was graded using 4 different scoring systems. Conjunctival staining, conjunctival hyperemia, and tear production were each measured using 2 different scoring systems. Ocular discomfort, the only patient-reported symptom primary outcome, was measured using 5 different instruments. CONCLUSION:A variety of outcome measures were used in these clinical trials. Clinically meaningful dry eye outcome measures and standardized measurements can optimize the assessment of and comparison of therapeutic benefits.
Purpose of review Ocular surface disease is a prevalent, diverse group of conditions that cause patient discomfort and decreased visual acuity and present considerable expense to both patients and healthcare systems. Autologous serum eye drops are a topical treatment modality derived from the patient's own blood. Use of serum eye drops for ocular surface disease has been promising due to biochemical similarities to endogenous tears. Recent findings Use of serum eye drops for moderate to severe ocular surface diseases such as dry eye, corneal epithelial defects, and inflammatory conditions has become more prevalent. Recent studies have demonstrated that the use of serum eye drops is well-tolerated by patients and associated with improvement in patient-reported outcomes and objective dry eye parameters. Production of serum eye drops may vary, treatment costs can be significant, and the quality of evidence for serum eye drop use published from randomized controlled trials is modest, particularly for long-term treatment. Accessibility remains an area for improvement and may be complemented by allogeneic serum eye drops. Summary Serum eye drops are frequently used as a safe, well-tolerated, and effective treatment for ocular surface disease. Further research is needed to assess long-term outcomes and improve accessibility.
Objective The study aimed to investigate factors influencing choice of specialty among ophthalmology and non-ophthalmology residency applicants. Patients and Methods Anonymous, web-based surveys were distributed through REDCap to the 2019 to 2020 residency applicants to the Penn State Department of Ophthalmology and, as a control group, Penn State medical students applying to non-ophthalmology residencies for the 2019 to 2020 cycle. The primary outcome was factors that influenced specialty choice among ophthalmology versus non-ophthalmology applicants. Secondary outcomes include hours of exposure to applicants' selected specialty in the medical school preclinical curriculum, and proportion of ophthalmology versus non-ophthalmology applicants who decided on, or developed a strong interest in, their specialty prior to clinical rotations. Results Surveys were completed by 203/441 (46.0%) ophthalmology and 85/139 (61.1%) non-ophthalmology applicants. Fewer than 20 hours of exposure to an applicant's selected specialty were provided in the medical school preclinical curriculum for 86.7% of ophthalmology and 42.4% of non-ophthalmology applicants ( p < 0.001). Ophthalmology applicants decided on, or developed a strong interest in, their selected specialty before clinical rotations at a similar rate to non-ophthalmology applicants (60.6 vs. 58.8%, respectively). Factors influencing specialty choice cited most commonly by ophthalmology applicants include professional satisfaction (94.1%), performing surgeries/procedures (92.6%), personal fit with specialty (91.1%), work-life balance (91.1%), and ability to see patients in a clinic setting (90.6%), compared to personal fit with specialty (95.3%)%, clinical rotation in selected specialty (95.3%), professional satisfaction (91.8%), intellectual stimulation (89.4%), and subinternship or away rotation (89.4%) among non-ophthalmology applicants. Conclusion Professional satisfaction and personal fit with specialty were among the most commonly cited factors influencing specialty choice for both groups. Other factors cited most frequently by ophthalmology applicants include performing surgeries/procedures, work-life balance, and ability to see patients in a clinic setting. Despite limited ophthalmology exposure in medical school preclinical curricula, ophthalmology applicants decided on, or developed a strong interest in, their selected specialty before clinical rotations at a rate similar to non-ophthalmology applicants.
Purpose: To investigate the relationship between measured anterior (ACA) and posterior (PCA) keratometric astigmatism and postoperative refractive astigmatism (RA) and to quantify noncorneal astigmatism (NCA) contributions to RA. Setting: Penn State College of Medicine, Hershey, Pennsylvania, USA. Design: Retrospective consecutive case series. Methods: Consecutive eyes underwent preoperative biometry (10LMaster 700) and tomography/topography using a dual Scheimpflug-placido disk-based device (Galilei G4), cataract surgery with implantation of a monofocal intraocular lens (IOL), and postoperative manifest refractions. RA was compared with keratometric astigmatism using the following methods: IOLMaster, SimK, CorT, SimK + measured PCA, total corneal power at the corneal plane (TCP2), and CorT(Total). An ocular residual astigmatism (ORA) vector was calculated between RA and each measured astigmatism. Results: Analysis was based on 296 eyes. ORA centroids were 0.28 @ 179, 0.45 0 001, 0.37 0 001, 0.19 0003,0.19 0001, and 0.23 @ 178 diopter (D) for the 6 aforementioned methods, respectively (P < .000001 [ORAx, ORAy]). Based on TCP2 measurements, eyes with against-the-rule ACA and with-the-rule (WITi) ACA had ORA centroids of 0.09 0 082 and 0.58 @ 001 D (P < .000001 [ORAx, ORAy]), respectively. ORA was nonzero and not entirely explained by the cornea, especially in those with WIR ACA. Conclusions: Total keratometric astigmatism did not explain all ocular astigmatism. Noncorneai contributions were significant, especially in eyes with WTR ACA. Copyright (C) 2020 Published by Wolters Kluwer on behalf of ASCRS and ESCRS
Purpose: To report occurrence of cicatrizing conjunctivitis as an extraglandular ocular manifestation of primary Sjogren's syndrome (SS). Methods: Medical charts of all patients with SS evaluated at two tertiary ophthalmological referral centers were reviewed. Patients who demonstrated clinical findings of cicatrizing conjunctivitis were included in this review. Patient and disease-related data including ocular complications, therapies and outcomes were collected. Results: Eight patients with a diagnosisis of SS were noted to have cicatrizing conjunctivitis findings over a period of 11 years (between 2009 and 2020). Mean age of patients was 79. All patients had a negative immunoreactant deposition in conjunctival biopsy. Mean follow-up time was 6 years (range, 18-197 months). Three patients had progression of conjunctival scarring. Worsening of vision occurred in 4 patients due to corneal complications, including ulceration, perforation and scarring. Conclusions: SS is an under-recognized etiology of severe progressive cicatrizing conjunctivitis that can lead to ocular morbidity and loss of vision without appropriate management.