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Importance: Racial, ethnic, and sex disparities exist in US clinical study enrollment, and the prevalence of these disparities in Pediatric Eye Disease Investigator Group (PEDIG) clinical studies has not been thoroughly assessed. Objective: To evaluate racial, ethnic, and sex representation in PEDIG clinical studies compared with the 2010 US Census pediatric population. Design, Setting, and Participants: This cross-sectional analysis examined PEDIG clinical studies based in the US from December 1, 1997 to September 12, 2022, 41 of which met inclusion criteria of a completed study, a study population younger than 18 years, and 1 or more accompanying publication. Data analysis was performed between November 2023 and February 2024. Exposure: Study participant race, ethnicity, and sex for each clinical study, as collected from peer-reviewed publications, patient-enrollment datasets, and ClinicalTrials.gov. Main Outcomes and Measures: Median enrollment percentages of female, White, Black, Hispanic, Asian, and other race participants were calculated and compared with the 2010 US Census pediatric population using a 1-sample Wilcoxon rank test. Proportionate enrollment was defined as no difference on a 1-sample Wilcoxon rank test if P ≥ .05. If P < .05, we determined if the median enrollment percentage was greater than or less than 2010 US Census proportion to determine if enrollees were underrepresented or overrepresented. To calculate the magnitude of overrepresentation or underrepresentation, enrollment-census difference (ECD) was defined as the difference between groups' median enrollment percentage and percentage representation in the 2010 US Census. Compound annual growth rate (CAGR) was used to measure temporal trends in enrollment, and logistic regression analysis was used to analyze factors that may have contributed to proportionate representation outcomes. Results: A total of 11 658 study participants in 41 clinical studies were included; mean (SD) participant age was 5.9 (2.8) years and 5918 study participants (50.8%) were female. In clinical studies meeting inclusion criteria, White participants were overrepresented (ECD, 0.19; 95% CI, 0.10-0.28; P < .001). Black participants (ECD, -0.07; 95% CI, -0.10 to -0.03; P < .001), Asian participants (ECD, -0.03; 95% CI, -0.04 to -0.02; P < .001), and Hispanic participants (ECD, -0.09; 95% CI, -0.13 to -0.05; P < .001) were underrepresented. Female participants were represented proportionately (ECD, 0.004; 95% CI, -0.036 to 0.045; P = .21). White and Asian participants demonstrated a decreasing trend in study enrollment from 1997 to 2022 (White: CAGR, -1.5%; 95% CI, -2.3% to -0.6%; Asian: CAGR, -1.7%; 95% CI, -2.0% to -1.4%), while Hispanic participants demonstrated an increasing enrollment trend (CAGR, 7.2%; 95% CI, 3.7%-10.7%). Conclusions and Relevance: In this retrospective cross-sectional study of PEDIG clinical studies from December 1, 1997 to September 12, 2022, Black, Hispanic, and Asian participants were underrepresented, White participants were overrepresented, and female participants were represented proportionally. Trends suggested increasing enrollment of Hispanic participants and decreasing enrollment of White participants over time. This study demonstrates an opportunity to advocate for increased enrollment of underrepresented groups in pediatric ophthalmology clinical studies.

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PURPOSE: To describe the prevalence and risk factors associated with amblyogenic refractive error in children with Coats disease. METHODS: The medical records of children (<18 years of age) with unilateral Coats disease treated at a single tertiary care center were retrospectively reviewed. Data collected included patient demographics, ocular examinations, and treatments. Outcomes included the prevalence and factors associated with amblyogenic refractive error. RESULTS: A total of 50 children (82% male) were included; of these, 37 (74%) had refractive data to review. The median age at presentation was 5 years (IQR, 2-10). The Coats disease classification was stage 1 in 1 (2%), stage 2 in 29 (58%), and stage 3 or greater in 20 (40%). Most children (76%) had at least one visit with a pediatric specialist; the rest were only seen by a retina specialist. Among patients with refractive data, amblyogenic refractive error was identified in 46%. Glasses were prescribed to 50% of children. Children diagnosed at an earlier age had increased odds of amblyogenic refractive error (OR = 0.72; 95% CI, 0.57-0.91; P = 0.006) than those diagnosed at an older age. CONCLUSIONS: Our results suggest that amblyogenic refractive error is prevalent among children with Coats disease, and refractions are not always performed. There is a need to coordinate care between pediatric and retina specialists caring for children with Coats disease to ensure timely diagnosis of amblyogenic refractive error to optimize visual outcomes in this population.

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Purpose: To describe the prevalence of missing sociodemographic data in the IRIS® (Intelligent Research in Sight) Registry and to identify practice-level characteristics associated with missing sociodemographic data. Design: Cross-sectional study. Participants: All patients with clinical encounters at practices participating in the IRIS Registry prior to December 31, 2020. Methods: We describe geographic and temporal trends in the prevalence of missing data for each sociodemographic variable (age, sex, race, ethnicity, geographic location, insurance type, and smoking status). Each practice contributing data to the registry was categorized based on the number of patients, number of physicians, geographic location, patient visit frequency, and patient population demographics. Main Outcome Measures: Multivariable linear regression was used to describe the association of practice-level characteristics with missing patient-level sociodemographic data. Results: This study included the electronic health records of 66 477 365 patients receiving care at 3306 practices participating in the IRIS Registry. The median number of patients per practice was 11 415 (interquartile range: 5849-24 148) and the median number of physicians per practice was 3 (interquartile range: 1-7). The prevalence of missing patient sociodemographic data were 0.1% for birth year, 0.4% for sex, 24.8% for race, 30.2% for ethnicity, 2.3% for 3-digit zip code, 14.8% for state, 5.5% for smoking status, and 17.0% for insurance type. The prevalence of missing data increased over time and varied at the state-level. Missing race data were associated with practices that had fewer visits per patient (P < 0.001), cared for a larger nonprivately insured patient population (P = 0.001), and were located in urban areas (P < 0.001). Frequent patient visits were associated with a lower prevalence of missing race (P < 0.001), ethnicity (P < 0.001), and insurance (P < 0.001), but a higher prevalence of missing smoking status (P < 0.001). Conclusions: There are geographic and temporal trends in missing race, ethnicity, and insurance type data in the IRIS Registry. Several practice-level characteristics, including practice size, geographic location, and patient population, are associated with missing sociodemographic data. While the prevalence and patterns of missing data may change in future versions of the IRIS registry, there will remain a need to develop standardized approaches for minimizing potential sources of bias and ensure reproducibility across research studies. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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BACKGROUND/AIMS: This was a cross-sectional comparative study. We evaluated the ability of three large language models (LLMs) (ChatGPT-3.5, ChatGPT-4, and Google Bard) to generate novel patient education materials (PEMs) and improve the readability of existing PEMs on paediatric cataract. METHODS: We compared LLMs' responses to three prompts. Prompt A requested they write a handout on paediatric cataract that was 'easily understandable by an average American.' Prompt B modified prompt A and requested the handout be written at a 'sixth-grade reading level, using the Simple Measure of Gobbledygook (SMOG) readability formula.' Prompt C rewrote existing PEMs on paediatric cataract 'to a sixth-grade reading level using the SMOG readability formula'. Responses were compared on their quality (DISCERN; 1 (low quality) to 5 (high quality)), understandability and actionability (Patient Education Materials Assessment Tool (≥70%: understandable, ≥70%: actionable)), accuracy (Likert misinformation; 1 (no misinformation) to 5 (high misinformation) and readability (SMOG, Flesch-Kincaid Grade Level (FKGL); grade level <7: highly readable). RESULTS: All LLM-generated responses were of high-quality (median DISCERN ≥4), understandability (≥70%), and accuracy (Likert=1). All LLM-generated responses were not actionable (<70%). ChatGPT-3.5 and ChatGPT-4 prompt B responses were more readable than prompt A responses (p<0.001). ChatGPT-4 generated more readable responses (lower SMOG and FKGL scores; 5.59±0.5 and 4.31±0.7, respectively) than the other two LLMs (p<0.001) and consistently rewrote them to or below the specified sixth-grade reading level (SMOG: 5.14±0.3). CONCLUSION: LLMs, particularly ChatGPT-4, proved valuable in generating high-quality, readable, accurate PEMs and in improving the readability of existing materials on paediatric cataract.

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PURPOSE: To describe the frequency of postoperative complications in children undergoing penetrating keratoplasty (PK). METHODS: This retrospective cohort study included pediatric patients (aged 0-18 years) in the Intelligent Research in Sight (IRIS) Registry who underwent primary PK between January 2013 and December 2020. Patients were identified using Current Procedure Terminology codes. Postoperative complications were identified using International Classification of Diseases Revision 9 and 10 codes and categorized as complications affecting the anterior segment (epithelial defect, infectious keratitis, neurotrophic keratitis, and glaucoma) or posterior segment (vitreous hemorrhage, retinal detachment, choroid detachment, choroidal hemorrhage, endophthalmitis, epiretinal membrane, and proliferative vitreoretinopathy). RESULTS: Of the 544 pediatric patients undergoing PK, 259 (47.6%) experienced postoperative complications. Anterior segment complications (n = 222, 40.8%) were more common than posterior segment complications (n = 96, 17.6%). The most common anterior complication was infectious keratitis (n = 163, 30.0%) with a median onset time of 275 days (IQR 50-560 days) after surgery. Vitreous hemorrhage (n = 52, 9.6%) and retinal detachment (n = 48, 8.8%) were the most common posterior segment complications. CONCLUSIONS: Infectious keratitis was the most common postoperative complication in children undergoing PK. More complications occurred in the anterior segment (70%) of the eye as compared with the posterior segment (30%). These findings demonstrate the challenges associated with pediatric PK and may help guide postoperative monitoring and management.

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A healthy 4-year-old boy referred for evaluation of an abnormal red reflex in the left eye was noted, on fundus examination, to have extensive white, striated lesions surrounding the optic nerve that involved the superior and inferior macular arcades. On further examination, he was found to have ipsilateral high myopia and amblyopia. The triad of unilateral myelinated retinal nerve fibers, myopia, and amblyopia led to a diagnosis of Straatsma syndrome, which requires early treatment to prevent permanent vision loss. Treatment comprised a contact lens for refractive correction of the left eye, patching of the right eye, and full-time polycarbonate protective lenses. With 2 years' follow-up, the left eye failed to improve appreciably.

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PURPOSE: To evaluate the clinical presentation, course, and outcomes of uveitis in paediatric patients with tubulointerstitial nephritis and uveitis syndrome (TINU). METHODS: Multicentric Retrospective Cohort Study 110 patients ≤21 years of age diagnosed with TINU from 10 sites across the United States and Canada. Clinical diagnosis of TINU required uveitis diagnosed by an ophthalmologist, elevated serum creatinine (SCr) and elevated urine ß2-microglobulin (ß2M) or abnormal urinalysis. Renal biopsy and systemic illness were not mandatory. Univariate and multivariate analysis was performed to analyse risk factors and treatment modalities. RESULTS: Median age was 13 years (Range (5.9-18.4); 52% male); median follow-up, 1.6 years (IQR 0.98-4.02). Uveitis was symptomatic in 90%, with bilateral anterior uveitis in 94%. Ninety-two (84%) patients required immunomodulatory treatment (IMT). Methotrexate (n = 44) and mycophenolate mofetil (n = 39) were the first agents after oral corticosteroids. 45% required addition of biologic agents (Adalimumab [n = 33], Infliximab [n = 8]). Younger age (p = 0.018), male sex (p = 0.011), and higher uveitis grade at presentation (p = 0.031) were associated with greater IMT ( ≥ 2) requirement. 53% had uveitis recurrence compared to 16% with nephritis recurrence. At the most recent visit, nephritis was controlled in 90%, while uveitis in 74%. Four (4%) patients required glaucoma surgery. Nine (8%) patients had renal complications. CONCLUSIONS: Most patients with TINU require steroid-sparing IMT for control of uveitis, with nearly half requiring addition of biologic agents. Urinalysis, urine ß2M and SCr testing should be considered in children presenting with uveitis, especially when the disease is bilateral and anterior.

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This cohort study examines ambulatory care revisits and same-day topical antibiotic prescription in insured patients with acute infectious conjunctivitis.

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Importance: Greater understanding of the association between strabismus and mental health conditions across sociodemographic backgrounds may inform strategies to improve mental well-being in this population. Objective: To describe the association of strabismus with mental health conditions in a diverse cohort of US adults. Design, Setting, and Participants: This cross-sectional study used data from the National Institutes of Health's All of Us Research Program, an ongoing program launched in 2015. The study included 3646 adults (aged ≥18 years) with strabismus and 3646 propensity score-matched controls. Statistical analysis was conducted from September 12, 2023, to January 29, 2024. Main Outcomes and Measures: Adults with strabismus were propensity score matched on age, gender, race and ethnicity, income, educational level, and insurance status in a 1:1 ratio with adults without strabismus. The prevalences of anxiety, depression, substance use and addiction, bipolar disorder, and schizophrenia spectrum disorder among adults with strabismus were compared with controls. Logistic regression was used to evaluate the association of mental health conditions with sociodemographic factors in each group. Results: This study included 3646 adults with strabismus (median age, 67 years [IQR, 53-76 years]; 2017 women [55%]) and 3646 propensity score-matched controls (median age, 67 years [IQR, 53-76 years]; 2017 women [55%]). Individuals with strabismus had higher prevalences of anxiety (1153 [32%] vs 519 [14%]; difference, 17%; 95% CI, 15%-19%; P < .001), depression (1189 [33%] vs 514 [14%]; difference, 19%; 95% CI, 17%-20%; P < .001), substance use and addiction (116 [3%] vs 51 [1%]; difference, 2%; 95% CI, 1%-3%; P < .001), bipolar disorder (253 [7%] vs 101 [3%]; difference, 4%; 95% CI, 3%-5%; P < .001), and schizophrenia spectrum disorder (103 [3%] vs 36 [1%]; difference, 2%; 95% CI, 1%-3%; P < .001) compared with individuals without strabismus. Among adults with strabismus, higher odds of mental health conditions were associated with younger age (odds ratio [OR], 1.11 per 10-year decrease; 95% CI, 1.06-1.16 per 10-year decrease), female gender (OR, 1.62; 95% CI, 1.41-1.85), Black or African American race and ethnicity (OR, 1.22; 95% CI, 1.01-1.48), low income (OR, 3.06; 95% CI, 2.56-3.67), and high school education or less (OR, 1.58; 95% CI, 1.34-1.85). Conclusions and Relevance: In a diverse and nationwide cohort, adults with strabismus were more likely to have mental health conditions compared with adults without strabismus. Further investigation into the risk factors for poor mental health among adults with strabismus across sociodemographic backgrounds may offer novel opportunities for interventions to improve mental well-being in this population.

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PURPOSE: To identify sociodemographic factors associated with the visual outcomes of retinoblastoma survivors. METHODS: Retrospective cohort study using a US-based clinical data registry. All individuals < 18 years of age with a history of retinoblastoma in the Intelligent Research in Sight (IRIS®) Registry (1/1/2013-12/31/2020). The primary outcome was visual acuity below the threshold for legal blindness (20/200 or worse) in at least one eye. Multivariable logistic regression was used to evaluate the association between visual outcomes and age, sex, laterality, race, ethnicity, type of insurance, and geographic location. RESULTS: This analysis included 1545 children with a history of retinoblastoma. The median length of follow-up was 4.1 years (IQR, 2.2-5.9 years) and the median age at most recent clinical visit was 12 years (IQR, 8-16 years). Retinoblastoma was unilateral in 54% of cases. Poor vision in at least one eye was identified in 78% of all children and poor vision in both eyes in 17% of those with bilateral disease. Poor visual outcomes were associated with unilateral diagnosis (OR, 1.55; 95% CI,1.13-2.12; p = .007), Black race (OR, 2.03; 95% CI, 1.19-3.47; p = .010), Hispanic ethnicity (OR, 1.65; 95% CI, 1.16-2.37; p = .006), and non-private insurance (OR, 1.47; 95% CI, 1.02-2.10; p = .037). CONCLUSIONS: Poor visual outcomes appear to be more common among Black, Hispanic, and publicly insured children with a history of retinoblastoma, raising concerns regarding healthcare inequities. Primary care physicians should ensure that young children receive red reflex testing during routine visits and consider retinoblastoma in the differential diagnosis of abnormal eye exams.

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PURPOSE: To compare the incidence of strabismus after upper and lower blepharoplasty in the United States. METHODS: Retrospective cohort study of adults (age ≥18 years) in the IRIS Registry (Intelligent Research in Sight) who underwent blepharoplasty between January 1, 2013 and December 31, 2020. The primary outcome was the Kaplan-Meier estimated cumulative incidence of strabismus diagnosis and surgery within 3 years of blepharoplasty. Multivariable Cox regression was used to determine the association of blepharoplasty type with strabismus diagnosis and surgery, adjusting for patient age, sex, and geographic region. RESULTS: Blepharoplasty was performed in 368,623 patients (median [interquartile range] age, 69 [63-75] years, and 69% female). Compared with those undergoing upper eyelid blepharoplasty, patients treated with lower eyelid blepharoplasty were slightly younger (median age, 66 vs. 69 years; p < 0.001) and more likely to be female (71% vs. 69%; p < 0.001). There was a greater 3-year incidence of strabismus diagnosis (2.0% vs. 1.5%; p < 0.001) and a greater 3-year incidence of strabismus surgery (0.15% vs. 0.06%; p = 0.003) for individuals undergoing lower vs. upper blepharoplasty. After adjusting for age, sex, and geographic region, lower blepharoplasty was associated with a higher 3-year risk of strabismus diagnosis (HR, 1.49; 95% CI, 1.23-1.81; p < 0.001) and surgery (HR, 2.53; 95% CI, 1.27-5.03; p = 0.008). CONCLUSIONS: This registry-based analysis found that individuals undergoing lower eyelid blepharoplasty were at higher risk of strabismus compared with those undergoing upper eyelid blepharoplasty. Using large databases to understand the incidence of complications of frequently performed procedures may improve ophthalmologists' ability to provide data-driven counseling on surgical risks prior to intervention.

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This cross-sectional study used data from a large nationwide registry to describe the factors associated with use of botulinum toxin injections for adults with strabismus in the United States. Botulinum toxin injections were performed on 3.1% of adults undergoing an intervention for strabismus between 2013 and 2020. Adults treated with botulinum toxin injections were more likely to be older and female. Compared to non-Hispanic White patients, non-Hispanic Black patients were three times less likely to receive treatment with botulinum toxin after adjusting for age, sex, geographic region, and type of insurance. Efforts to understand the factors contributing to disparities in the use of botulinum toxin for strabismus may lead to opportunities for more equitable access to this intervention.

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PURPOSE: To examine the relationship between the Child Opportunity Index (COI) and severity of retinoblastoma at presentation. DESIGN: Cross-sectional study. METHODS: Children (age <18 years) treated for retinoblastoma at a tertiary care center between January 2000 and May 2023 were included. Residential census tract was used to determine the overall and domain-specific COI score for each child. Collected variables included age, sex, race/ethnicity, insurance type, and the International Classification of Retinoblastoma (ICRB) Group at initial examination. The primary outcome was Group D or E retinoblastoma at presentation. Mixed effects regression models were used to estimate the association of COI scores with disease severity at presentation. RESULTS: This study included 125 children (51.2% male). Median age at diagnosis was 13 months (IQR, 5-24 months). One hundred nine (87.2%) children presented with Group D or E retinoblastoma and 33 (26.4%) resided in low or very low opportunity neighborhoods. Children residing in neighborhoods with low overall COI scores (OR, 1.62; 95% CI, 1.01-2.58; P = .044) and low education COI scores (OR, 1.77; 95% CI, 1.13-2.79; P = .013) were at increased odds of presenting with ICRB Group D or E retinoblastoma after adjusting for individual-level socioeconomic factors. CONCLUSION: Children residing in low opportunity neighborhoods-particularly low education opportunity-more often presented with advanced stage retinoblastoma than children residing in neighborhoods with higher opportunity scores. Efforts to improve preventative vision care and access to eye specialty care for children residing in low-resource areas are needed to reduce existing disparities in retinoblastoma.

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This cross-sectional study uses a nationally representative survey of the US pediatric population to identify gaps in the vision screening pathway.

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PURPOSE: To compare demographic and clinical factors associated with glaucoma following cataract surgery (GFCS) and glaucoma surgery rates between infants, toddlers, and older children using a large, ophthalmic registry. DESIGN: Retrospective cohort study. PARTICIPANTS: Patients in the IRIS® Registry (Intelligent Research in Sight) who underwent cataract surgery at ≤ 17 years old and between January 1, 2013 and December 31, 2020. METHODS: Glaucoma diagnosis and procedural codes were extracted from the electronic health records of practices participating in the IRIS Registry. Children with glaucoma diagnosis or surgery before cataract removal were excluded. The Kaplan-Meier estimator was used to determine the cumulative probability of GFCS diagnosis and glaucoma surgery after cataract surgery. Multivariable Cox regression was used to identify factors associated with GFCS and glaucoma surgery. MAIN OUTCOME MEASURES: Cumulative probability of glaucoma diagnosis and surgical intervention within 5 years after cataract surgery. RESULTS: The study included 6658 children (median age, 10.0 years; 46.2% female). The 5-year cumulative probability of GFCS was 7.1% (95% confidence interval [CI], 6.1%-8.1%) and glaucoma surgery was 2.6% (95% CI, 1.9%-3.2%). The 5-year cumulative probability of GFCS for children aged < 1 year was 22.3% (95% CI, 15.7%-28.4%). Risk factors for GFCS included aphakia (hazard ratio [HR], 2.63; 95% CI, 1.96-3.57), unilateral cataract (HR, 1.48; 95% CI, 1.12-1.96), and Black race (HR, 1.61; 95% CI, 1.12-2.32). The most common surgery was glaucoma drainage device insertion (32.6%), followed by angle surgery (23.3%), cyclophotocoagulation (15.1%), and trabeculectomy (5.8%). CONCLUSIONS: Glaucoma following cataract surgery diagnosis in children in the IRIS Registry was associated with young age, aphakia, unilateral cataract, and Black race. Glaucoma drainage device surgery was the preferred surgical treatment, consistent with the World Glaucoma Association 2013 consensus recommendations for GFCS management. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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