To assess anterior chamber (AC) subclinical inflammation using a noninvasive method in patients undergoing Descemet membrane endothelial keratoplasty (DMEK).
Design
Retrospective interventional case series.
Participants
This study included 83 eyes from 73 patients who underwent DMEK surgery and 15 control eyes from 15 healthy individuals.
Methods
The number of hyperreflective dots representing AC cells and optical density ratio (aqueous-to-air relative intensity [ARI] index) for flare quantification were calculated from anterior segment-OCT images. Aqueous-to-air relative intensity index and AC cells were calculated preoperatively and postoperatively at 1 week (T1), 1 month (T2), and 3 months (T3) after DMEK surgery. Baseline values were compared with a healthy control group.
Main Outcome Measures
Anterior chamber cell count and ARI index over time; association with postoperative posterior stromal ripples (PSRs) and rebubbling.
Results
Baseline ARI index was significantly higher in the DMEK group compared with controls, whereas no significant difference in AC cell count was observed. Anterior chamber cell count increased postoperatively from a median of 1.1 cells (0.6–2.1) at baseline to 3.5 (1.7–5.3) at T1 (P < 0.001), to 1.7 (1.1–3.0) at T2 (P = 0.03), and to 2.1 (1.1–4.2) at T3 (P = 0.01). The ARI index also increased from a median of 98.3 (84.1–121.9) at baseline to 142.8 (119.8–221.3) at T1 (P < 0.001) and 114.4 (101.7–140.7) at T2 (P < 0.001). Higher ARI at T1 was weakly associated with postoperative PSR (odds ratio [OR] = 1.63; 95% confidence interval [CI], 1.00–2.67; P = 0.048), whereas postoperative PSR were strongly associated with rebubbling (OR = 26.00; 95% CI, 3.20–211.18; P = 0.002).
Conclusions
Anterior segment-OCT enables noninvasive detection of subclinical inflammation after DMEK surgery. The presence of markers of inflammation can increase the risk of early postoperative complications.
Financial Disclosure(s)
The authors have no proprietary or commercial interest in any materials discussed in this article.
{"title":"Anterior Chamber Inflammation and Descemet Membrane Endothelial Keratoplasty","authors":"Sabrina Vaccaro MD , Giacomo Beschi MD , Paola Cannistrà MD , Matteo Airaldi MD , Marica Ventura MD , Francesco Semeraro MD , Vito Romano MD","doi":"10.1016/j.xops.2025.100946","DOIUrl":"10.1016/j.xops.2025.100946","url":null,"abstract":"<div><h3>Purpose</h3><div>To assess anterior chamber (AC) subclinical inflammation using a noninvasive method in patients undergoing Descemet membrane endothelial keratoplasty (DMEK).</div></div><div><h3>Design</h3><div>Retrospective interventional case series.</div></div><div><h3>Participants</h3><div>This study included 83 eyes from 73 patients who underwent DMEK surgery and 15 control eyes from 15 healthy individuals.</div></div><div><h3>Methods</h3><div>The number of hyperreflective dots representing AC cells and optical density ratio (aqueous-to-air relative intensity [ARI] index) for flare quantification were calculated from anterior segment-OCT images. Aqueous-to-air relative intensity index and AC cells were calculated preoperatively and postoperatively at 1 week (T1), 1 month (T2), and 3 months (T3) after DMEK surgery. Baseline values were compared with a healthy control group.</div></div><div><h3>Main Outcome Measures</h3><div>Anterior chamber cell count and ARI index over time; association with postoperative posterior stromal ripples (PSRs) and rebubbling.</div></div><div><h3>Results</h3><div>Baseline ARI index was significantly higher in the DMEK group compared with controls, whereas no significant difference in AC cell count was observed. Anterior chamber cell count increased postoperatively from a median of 1.1 cells (0.6–2.1) at baseline to 3.5 (1.7–5.3) at T1 (<em>P</em> < 0.001), to 1.7 (1.1–3.0) at T2 (<em>P</em> = 0.03), and to 2.1 (1.1–4.2) at T3 (<em>P</em> = 0.01). The ARI index also increased from a median of 98.3 (84.1–121.9) at baseline to 142.8 (119.8–221.3) at T1 (<em>P</em> < 0.001) and 114.4 (101.7–140.7) at T2 (<em>P</em> < 0.001). Higher ARI at T1 was weakly associated with postoperative PSR (odds ratio [OR] = 1.63; 95% confidence interval [CI], 1.00–2.67; <em>P</em> = 0.048), whereas postoperative PSR were strongly associated with rebubbling (OR = 26.00; 95% CI, 3.20–211.18; <em>P</em> = 0.002).</div></div><div><h3>Conclusions</h3><div>Anterior segment-OCT enables noninvasive detection of subclinical inflammation after DMEK surgery. The presence of markers of inflammation can increase the risk of early postoperative complications.</div></div><div><h3>Financial Disclosure(s)</h3><div>The authors have no proprietary or commercial interest in any materials discussed in this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100946"},"PeriodicalIF":4.6,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145417482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-23DOI: 10.1016/j.xops.2025.100945
Jawad Muayad BS , Hajar N. Tukur MD , Asad Loya MD , Muhammad Z. Chauhan MD, MS , Zain S. Hussain MD , Andrew G. Lee MD , Sami S. Dahr MD, MS
Purpose
To evaluate the impact of renal function on the risk of developing diabetic macular edema (DME) among patients newly diagnosed with type 2 diabetes mellitus (T2DM).
Design
A retrospective cohort study.
Participants
Patients with T2DM without pre-existing ophthalmic diabetic complications, stratified by kidney function (estimated glomerular filtration rate [eGFR]).
Methods
We analyzed electronic health record data from the TriNetX network, including patients diagnosed with T2DM from 2005 to 2025. Patients were grouped based on baseline eGFR levels documented within 6 months of diabetes diagnosis: normal/high (≥90 mL/min), mild chronic kidney disease (CKD; 60–89 mL/min), mild-to-moderate CKD (45–59 mL/min), moderate-to-severe CKD (30–44 mL/min), severe CKD (15–29 mL/min), and end-stage renal disease (ESRD) (<15 mL/min). Propensity score matching balanced covariates including age, sex, race/ethnicity, hemoglobin A1c, hypertension, hyperlipidemia, insulin and oral hypoglycemic agent use, fenofibrate use, prostaglandin analog use, and Diabetes Complications Severity Index components.
Main Outcome Measures
Incidence of DME within 3 years after diabetes diagnosis.
Results
Postmatching, each cohort was balanced in patient characteristics. Compared with patients with normal kidney function, there was a progressively higher risk of DME with declining kidney function: mild CKD (hazard ratio [HR] 1.05, 95% confidence interval [CI] 1.02–1.08), mild-to-moderate CKD (HR 1.41, 95% CI 1.36–1.46), moderate-to-severe CKD (HR 1.78, 95% CI 1.70–1.87), severe CKD (HR 2.35, 95% CI 2.21–2.51), and ESRD (HR 2.53, 95% CI 2.33–2.74). Subgroup analysis restricted to normoalbuminuric patients (urine albumin-to-creatinine ratio ≤30 mg/g) also demonstrated significant associations, highlighting the potential independent effect of declining eGFR on DME risk. Additionally, kidney transplantation among ESRD patients was associated with reduced DME risk (HR 0.65, 95% CI 0.51–0.81).
Conclusions
Our findings reveal a clear, progressive relationship between declining renal function and increased DME risk, independent of albuminuria. These results underscore the need for proactive ophthalmic screening in diabetic patients with impaired renal function and suggest renal improvement may mitigate DME risk.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的探讨肾功能对新诊断2型糖尿病（T2DM）患者发生糖尿病性黄斑水肿（DME）风险的影响。设计：回顾性队列研究。参与者：2型糖尿病患者，既往无眼部糖尿病并发症，按肾功能（估计肾小球滤过率[eGFR]）分层。方法我们分析来自TriNetX网络的电子健康记录数据，包括2005年至2025年诊断为T2DM的患者。根据糖尿病诊断后6个月内记录的基线eGFR水平对患者进行分组：正常/高（≥90 mL/min）、轻度慢性肾病（CKD; 60-89 mL/min）、轻中度CKD （45-59 mL/min）、中重度CKD （30-44 mL/min）、重度CKD （15 - 29 mL/min）和终末期肾病（ESRD） （15 mL/min）。倾向评分匹配平衡协变量包括年龄、性别、种族/民族、血红蛋白A1c、高血压、高脂血症、胰岛素和口服降糖药使用、非诺贝特使用、前列腺素类似物使用和糖尿病并发症严重程度指数成分。主要观察指标：糖尿病诊断后3年内DME的发生率。结果匹配后，各队列患者特征平衡。与肾功能正常的患者相比，肾功能下降的患者发生DME的风险逐渐增加：轻度CKD（风险比[HR] 1.05, 95%可信区间[CI] 1.02-1.08）、轻度至中度CKD（风险比[HR] 1.41, 95% CI 1.36-1.46）、中度至重度CKD（风险比[HR] 1.78, 95% CI 1.70-1.87）、重度CKD（风险比2.35,95% CI 2.21-2.51）和ESRD（风险比2.53,95% CI 2.33-2.74）。亚组分析仅限于正常蛋白尿患者（尿白蛋白与肌酐比值≤30 mg/g）也显示出显著的相关性，突出了eGFR下降对DME风险的潜在独立影响。此外，肾移植与ESRD患者DME风险降低相关（HR 0.65, 95% CI 0.51-0.81）。结论研究结果显示，肾功能下降与DME风险增加之间存在明显的递进关系，与蛋白尿无关。这些结果强调了对肾功能受损的糖尿病患者进行前瞻性眼科筛查的必要性，并提示肾脏改善可能会降低DME的风险。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。
{"title":"Nationwide Analysis of Progressive Kidney Function Decline and Diabetic Macular Edema in Type 2 Diabetes","authors":"Jawad Muayad BS , Hajar N. Tukur MD , Asad Loya MD , Muhammad Z. Chauhan MD, MS , Zain S. Hussain MD , Andrew G. Lee MD , Sami S. Dahr MD, MS","doi":"10.1016/j.xops.2025.100945","DOIUrl":"10.1016/j.xops.2025.100945","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the impact of renal function on the risk of developing diabetic macular edema (DME) among patients newly diagnosed with type 2 diabetes mellitus (T2DM).</div></div><div><h3>Design</h3><div>A retrospective cohort study.</div></div><div><h3>Participants</h3><div>Patients with T2DM without pre-existing ophthalmic diabetic complications, stratified by kidney function (estimated glomerular filtration rate [eGFR]).</div></div><div><h3>Methods</h3><div>We analyzed electronic health record data from the TriNetX network, including patients diagnosed with T2DM from 2005 to 2025. Patients were grouped based on baseline eGFR levels documented within 6 months of diabetes diagnosis: normal/high (≥90 mL/min), mild chronic kidney disease (CKD; 60–89 mL/min), mild-to-moderate CKD (45–59 mL/min), moderate-to-severe CKD (30–44 mL/min), severe CKD (15–29 mL/min), and end-stage renal disease (ESRD) (<15 mL/min). Propensity score matching balanced covariates including age, sex, race/ethnicity, hemoglobin A1c, hypertension, hyperlipidemia, insulin and oral hypoglycemic agent use, fenofibrate use, prostaglandin analog use, and Diabetes Complications Severity Index components.</div></div><div><h3>Main Outcome Measures</h3><div>Incidence of DME within 3 years after diabetes diagnosis.</div></div><div><h3>Results</h3><div>Postmatching, each cohort was balanced in patient characteristics. Compared with patients with normal kidney function, there was a progressively higher risk of DME with declining kidney function: mild CKD (hazard ratio [HR] 1.05, 95% confidence interval [CI] 1.02–1.08), mild-to-moderate CKD (HR 1.41, 95% CI 1.36–1.46), moderate-to-severe CKD (HR 1.78, 95% CI 1.70–1.87), severe CKD (HR 2.35, 95% CI 2.21–2.51), and ESRD (HR 2.53, 95% CI 2.33–2.74). Subgroup analysis restricted to normoalbuminuric patients (urine albumin-to-creatinine ratio ≤30 mg/g) also demonstrated significant associations, highlighting the potential independent effect of declining eGFR on DME risk. Additionally, kidney transplantation among ESRD patients was associated with reduced DME risk (HR 0.65, 95% CI 0.51–0.81).</div></div><div><h3>Conclusions</h3><div>Our findings reveal a clear, progressive relationship between declining renal function and increased DME risk, independent of albuminuria. These results underscore the need for proactive ophthalmic screening in diabetic patients with impaired renal function and suggest renal improvement may mitigate DME risk.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100945"},"PeriodicalIF":4.6,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145417403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-19DOI: 10.1016/j.xops.2025.100942
Zhan-Pei Bai , Yi-Suo Pan BMed , Yi-Xin Cai MSc , Chong Chen PhD , Di Tao BMed , Xin-Yi Zhao BMed , Yi-Fan Shen , Feng Chen MMed , Jun-Hua Li MD , Jia Qu MD , Xiu-Feng Huang PhD
Purpose
To explore the shared genetic architecture, causal relationships, and cell type–specific expression patterns of pleiotropic genes in age-related macular degeneration (AMD), cataract, and primary open-angle glaucoma (POAG), uncovering molecular mechanisms and informing targeted therapies.
Design
A genetic association study combined with cross-trait meta-analyses, Mendelian randomization analyses, and single-cell RNA sequencing (scRNA-seq) analysis.
Subjects
The data related to 3 age-related ocular diseases, including AMD, cataract, and POAG, were obtained from publicly available genome-wide association study (GWAS) databases.
Methods
We conducted a comprehensive genetic analysis utilizing GWAS summary statistics to examine genetic correlations among AMD, cataract, and POAG. Cross-trait meta-analyses were performed to identify shared risk loci. Mendelian randomization was employed to investigate potential causal relationships between these conditions. Additionally, we analyzed scRNA-seq data to examine the expression patterns of identified pleiotropic genes across different retinal cell types.
Main Outcome Measures
Identification of shared risk single nucleotide polymorphisms (SNPs) and pleiotropic loci. Causal relationships between AMD, cataract, and POAG. Cell type–specific expression patterns of pleiotropic genes in retinal cells.
Results
Our analysis revealed significant genetic correlations, with a negative correlation between AMD and POAG and a positive correlation between cataract and POAG. Cross-trait meta-analyses identified shared risk SNPs, with CDKN2B-AS1 emerging as a notable pleiotropic locus. Mendelian randomization analyses suggested causal relationships between AMD and cataract, as well as between POAG and AMD. Single-cell expression analysis demonstrated cell type–specific expression patterns of pleiotropic genes including ATXN2, HTRA1, SIX6, and THSD7A across retinal cells.
Conclusions
This study provides compelling evidence for shared genetic architecture and causal relationships among AMD, cataract, and POAG. The identification of specific pleiotropic genes and their expression patterns across retinal cell types offers new insights into the molecular mechanisms underlying these age-related ocular diseases, potentially informing the development of targeted therapeutic strategies.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Investigating the Shared Genetic Architecture of 3 Age-Related Ocular Disorders","authors":"Zhan-Pei Bai , Yi-Suo Pan BMed , Yi-Xin Cai MSc , Chong Chen PhD , Di Tao BMed , Xin-Yi Zhao BMed , Yi-Fan Shen , Feng Chen MMed , Jun-Hua Li MD , Jia Qu MD , Xiu-Feng Huang PhD","doi":"10.1016/j.xops.2025.100942","DOIUrl":"10.1016/j.xops.2025.100942","url":null,"abstract":"<div><h3>Purpose</h3><div>To explore the shared genetic architecture, causal relationships, and cell type–specific expression patterns of pleiotropic genes in age-related macular degeneration (AMD), cataract, and primary open-angle glaucoma (POAG), uncovering molecular mechanisms and informing targeted therapies.</div></div><div><h3>Design</h3><div>A genetic association study combined with cross-trait meta-analyses, Mendelian randomization analyses, and single-cell RNA sequencing (scRNA-seq) analysis.</div></div><div><h3>Subjects</h3><div>The data related to 3 age-related ocular diseases, including AMD, cataract, and POAG, were obtained from publicly available genome-wide association study (GWAS) databases.</div></div><div><h3>Methods</h3><div>We conducted a comprehensive genetic analysis utilizing GWAS summary statistics to examine genetic correlations among AMD, cataract, and POAG. Cross-trait meta-analyses were performed to identify shared risk loci. Mendelian randomization was employed to investigate potential causal relationships between these conditions. Additionally, we analyzed scRNA-seq data to examine the expression patterns of identified pleiotropic genes across different retinal cell types.</div></div><div><h3>Main Outcome Measures</h3><div>Identification of shared risk single nucleotide polymorphisms (SNPs) and pleiotropic loci. Causal relationships between AMD, cataract, and POAG. Cell type–specific expression patterns of pleiotropic genes in retinal cells.</div></div><div><h3>Results</h3><div>Our analysis revealed significant genetic correlations, with a negative correlation between AMD and POAG and a positive correlation between cataract and POAG. Cross-trait meta-analyses identified shared risk SNPs, with <em>CDKN2B-AS1</em> emerging as a notable pleiotropic locus. Mendelian randomization analyses suggested causal relationships between AMD and cataract, as well as between POAG and AMD. Single-cell expression analysis demonstrated cell type–specific expression patterns of pleiotropic genes including <em>ATXN2</em>, <em>HTRA1</em>, <em>SIX6</em>, and <em>THSD7A</em> across retinal cells.</div></div><div><h3>Conclusions</h3><div>This study provides compelling evidence for shared genetic architecture and causal relationships among AMD, cataract, and POAG. The identification of specific pleiotropic genes and their expression patterns across retinal cell types offers new insights into the molecular mechanisms underlying these age-related ocular diseases, potentially informing the development of targeted therapeutic strategies.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100942"},"PeriodicalIF":4.6,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145363408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To evaluate the efficacy of intravitreal dental pulp stem cell–conditioned medium (DPSC-CM) versus human umbilical vein endothelial cell–CM (HUVEC-CM) in preserving retinal function after ischemia–reperfusion injury (IRI) in rabbits.
Design
Experimental animal study.
Subjects
Eighteen rabbits subjected to retinal IRI and randomized to receive intravitreal injections of DPSC-CM, HUVEC-CM, or balanced salt solution (BSS) (n = 6 per group).
Intervention
After induction of retinal IRI, rabbits received intravitreal injections of DPSC-CM, HUVEC-CM, or BSS. Electroretinography (ERG) was performed 7 days postinjection to assess retinal function, measuring both dark-adapted (DA) and light-adapted (LA) responses.
Main Outcome Measures
Preservation of a-wave and b-wave amplitudes on ERG as indicators of photoreceptor (PR) and bipolar cell function, respectively.
Results
Both DPSC-CM and HUVEC-CM significantly preserved b-wave amplitudes in DA ERG responses compared to BSS (P < 0.05). Dental pulp stem cell–conditioned medium demonstrated superior preservation of a-wave amplitudes, indicating enhanced PR function. Both treatments also maintained LA ERG responses. Transient mucopurulent discharge in 2 DPSC-CM–treated rabbits and a localized posterior subcapsular opacity in one BSS-treated rabbit were observed; all resolved without sequelae.
Conclusions
Intravitreal DPSC-CM and HUVEC-CM are effective in preserving retinal function after IRI, with DPSC-CM showing particular advantage in PR protection. These results support further investigation into DPSC-CM and HUVEC-CM as potential therapies for retinal ischemic conditions, such as retinal artery occlusion and anterior ischemic optic neuropathy.
Financial Disclosure(s)
The authors have no proprietary or commercial interest in any materials discussed in this article.
{"title":"Functional Efficacy of Intravitreal Dental Pulp Stem Cells versus Human Umbilical Vein Endothelial Cell–Conditioned Media in Experimental Retinal Ischemia–Reperfusion Injury","authors":"M. Hossein Nowroozzadeh MD, Mehrnoosh Maalhagh MD, Fatemeh Sanie-Jahromi PhD, Navid Fazlinejad MD, Farid Shahrivar MD, Mohsen Farvardin MD","doi":"10.1016/j.xops.2025.100941","DOIUrl":"10.1016/j.xops.2025.100941","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the efficacy of intravitreal dental pulp stem cell–conditioned medium (DPSC-CM) versus human umbilical vein endothelial cell–CM (HUVEC-CM) in preserving retinal function after ischemia–reperfusion injury (IRI) in rabbits.</div></div><div><h3>Design</h3><div>Experimental animal study.</div></div><div><h3>Subjects</h3><div>Eighteen rabbits subjected to retinal IRI and randomized to receive intravitreal injections of DPSC-CM, HUVEC-CM, or balanced salt solution (BSS) (n = 6 per group).</div></div><div><h3>Intervention</h3><div>After induction of retinal IRI, rabbits received intravitreal injections of DPSC-CM, HUVEC-CM, or BSS. Electroretinography (ERG) was performed 7 days postinjection to assess retinal function, measuring both dark-adapted (DA) and light-adapted (LA) responses.</div></div><div><h3>Main Outcome Measures</h3><div>Preservation of a-wave and b-wave amplitudes on ERG as indicators of photoreceptor (PR) and bipolar cell function, respectively.</div></div><div><h3>Results</h3><div>Both DPSC-CM and HUVEC-CM significantly preserved b-wave amplitudes in DA ERG responses compared to BSS (<em>P</em> < 0.05). Dental pulp stem cell–conditioned medium demonstrated superior preservation of a-wave amplitudes, indicating enhanced PR function. Both treatments also maintained LA ERG responses. Transient mucopurulent discharge in 2 DPSC-CM–treated rabbits and a localized posterior subcapsular opacity in one BSS-treated rabbit were observed; all resolved without sequelae.</div></div><div><h3>Conclusions</h3><div>Intravitreal DPSC-CM and HUVEC-CM are effective in preserving retinal function after IRI, with DPSC-CM showing particular advantage in PR protection. These results support further investigation into DPSC-CM and HUVEC-CM as potential therapies for retinal ischemic conditions, such as retinal artery occlusion and anterior ischemic optic neuropathy.</div></div><div><h3>Financial Disclosure(s)</h3><div>The authors have no proprietary or commercial interest in any materials discussed in this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100941"},"PeriodicalIF":4.6,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145363984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-17DOI: 10.1016/j.xops.2025.100940
Xiaotong Han MD, PhD , Yurui Zhang MS , Ling Jin MS , Decai Wang MD, PhD , Mingguang He MD, PhD , Yangfa Zeng MD
Purpose
To evaluate the efficacy and safety of the new defocus spectacle lens in preventing myopia progression compared with the conventional single-vision spectacle lens (SVL).
Design
A randomized, open-label, controlled clinical trial.
Subjects
Children aged 6 to 14 years with a cycloplegic spherical equivalent refraction (SER) of –1.00 to –3.50 diopters (D) in both eyes were enrolled.
Methods
Eligible participants were randomly assigned in a 1:1 ratio to receive either the novel defocus spectacle lens (MYOGEN) or the SVL. Data from the right eyes at the 12-month follow-up were used for the current analysis.
Main Outcome Measures
The primary outcome was the 1-year change in SER from baseline to 12 months. Secondary outcomes included changes in axial length (AL), choroidal thickness, subjective visual quality scores, and daily spectacle wear time. Axial length was designated as the main secondary outcome due to its close relationship with myopia progression.
Results
A total of 85 patients were assigned to the MYOGEN group and 89 to the SVL group, with mean (standard deviation) ages of 10.44 (0.92) years and 10.61 (0.73) years, respectively. After 1 year, myopia progression and axial elongation were all significantly less in the MYOGEN group than in the SVL group (SER change: –0.80 ± 0.44 D and –1.06 ± 0.51 D, respectively; AL change: 0.25 ± 0.15 mm and 0.37 ± 0.18 mm, respectively; all P < 0.001). Among patients with good compliance (≥8 hours/day and ≥5 days/week), the treatment effect was even more pronounced for SER (adjusted difference: 0.40 D [95% confidence interval [CI], 0.25 to 0.56]) and AL (adjusted difference: –0.15 mm [95% CI, –0.21 to –0.10]). No significant between-group differences were observed in compliance with spectacle wear and subjective visual quality.
Conclusions
Compared with the SVL, MYOGEN was shown to reduce myopia progression and axial elongation over the 1-year follow-up period.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"One-Year Myopia Control Efficacy of a New Defocus Spectacle Lens: A Randomized Clinical Trial","authors":"Xiaotong Han MD, PhD , Yurui Zhang MS , Ling Jin MS , Decai Wang MD, PhD , Mingguang He MD, PhD , Yangfa Zeng MD","doi":"10.1016/j.xops.2025.100940","DOIUrl":"10.1016/j.xops.2025.100940","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the efficacy and safety of the new defocus spectacle lens in preventing myopia progression compared with the conventional single-vision spectacle lens (SVL).</div></div><div><h3>Design</h3><div>A randomized, open-label, controlled clinical trial.</div></div><div><h3>Subjects</h3><div>Children aged 6 to 14 years with a cycloplegic spherical equivalent refraction (SER) of –1.00 to –3.50 diopters (D) in both eyes were enrolled.</div></div><div><h3>Methods</h3><div>Eligible participants were randomly assigned in a 1:1 ratio to receive either the novel defocus spectacle lens (MYOGEN) or the SVL. Data from the right eyes at the 12-month follow-up were used for the current analysis.</div></div><div><h3>Main Outcome Measures</h3><div>The primary outcome was the 1-year change in SER from baseline to 12 months. Secondary outcomes included changes in axial length (AL), choroidal thickness, subjective visual quality scores, and daily spectacle wear time. Axial length was designated as the main secondary outcome due to its close relationship with myopia progression.</div></div><div><h3>Results</h3><div>A total of 85 patients were assigned to the MYOGEN group and 89 to the SVL group, with mean (standard deviation) ages of 10.44 (0.92) years and 10.61 (0.73) years, respectively. After 1 year, myopia progression and axial elongation were all significantly less in the MYOGEN group than in the SVL group (SER change: –0.80 ± 0.44 D and –1.06 ± 0.51 D, respectively; AL change: 0.25 ± 0.15 mm and 0.37 ± 0.18 mm, respectively; all <em>P</em> < 0.001). Among patients with good compliance (≥8 hours/day and ≥5 days/week), the treatment effect was even more pronounced for SER (adjusted difference: 0.40 D [95% confidence interval [CI], 0.25 to 0.56]) and AL (adjusted difference: –0.15 mm [95% CI, –0.21 to –0.10]). No significant between-group differences were observed in compliance with spectacle wear and subjective visual quality.</div></div><div><h3>Conclusions</h3><div>Compared with the SVL, MYOGEN was shown to reduce myopia progression and axial elongation over the 1-year follow-up period.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100940"},"PeriodicalIF":4.6,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145417411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To evaluate the clinical course of retinal pigment epithelial and outer retinal atrophy (RORA) with best-corrected visual acuity (BCVA) and risk factors for rapid progression to explore the pathogenesis.
Design
Retrospective observational study.
Subjects
Data on eyes with fovea-involved RORA associated with age-related macular degeneration were collected over time from 10 hospitals in Japan.
Methods
Data on ophthalmic examination, BCVA, and OCT images were analyzed.
Main Outcome Measures
Relationships between changes in BCVA and extents of RORA and outer plexiform layer (OPL) deterioration and their associations with central choroidal thickness (CCT) and pachychoroid characteristics at baseline were evaluated.
Results
Of the 53 eyes of 53 patients (mean age; 74.9 ± 1.4 years), 32 eyes (60.4%) belonged to men. The progression in the mean extent of OPL deterioration was evident at year 1, whereas that of RORA, BCVA impairment, thinning of the central retinal thickness, and CCT became apparent at year 2 (P < 0.05). Changes in the extents of RORA and OPL deterioration and BCVA were correlated (P < 0.05). Baseline CCT negatively correlated with baseline RORA and the changes in extent of RORA (P < 0.05). After adjusting for age and sex, a longer extent of RORA at baseline predicted BCVA worsening ≥0.04 per year (odds ratio [OR], 3.444; 95% confidence interval [CI], 1.015–11.691; P = 0.047). Greater horizontal extension of RORA ≥175 μm/y was frequently observed in eyes with thinner CCT <180 μm (OR, 4.684; 95% CI, 1.288–17.036; P = 0.019), subretinal drusenoid deposits (SDDs) (OR, 6.714; 95% CI, 1.555–28.988; P = 0.011), and drusen (OR, 4.392; 95% CI, 1.176–16.410; P = 0.028) and less observed in eyes with pachychoroid characteristics (OR, 0.038; 95% CI, 0.003–0.454, P = 0.010) at baseline after adjusting for age and baseline extent of RORA; similar risks for greater vertical extension of RORA were observed.
Conclusions
The change in BCVA paralleled the changes in the extents of RORA and OPL deterioration. Rapid BCVA impairment was observed in eyes with longer RORA at baseline. A thinner choroid, SDD, and drusen were risk factors, and pachychoroid characteristics were protective factors against RORA progression. Further studies are warranted to better understand the progression of RORA and vision loss.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的评价具有最佳矫正视力（BCVA）的视网膜色素上皮和外视网膜萎缩（RORA）的临床病程及快速进展的危险因素，探讨其发病机制。设计回顾性观察性研究。研究人员从日本的10家医院收集了与年龄相关性黄斑变性相关的累及中央凹的RORA眼睛的数据。方法分析眼科检查、BCVA、OCT影像资料。评估BCVA变化与RORA和外丛状层（OPL）恶化程度的关系，以及它们与基线时中央脉络膜厚度（CCT）和厚脉络膜特征的关系。结果53例患者53眼（平均年龄74.9±1.4岁），男性32眼（60.4%）。OPL平均恶化程度的进展在第1年明显，而RORA、BCVA损伤、视网膜中央厚度变薄和CCT的进展在第2年变得明显（P < 0.05）。RORA、OPL恶化程度的变化与BCVA有相关性（P < 0.05）。基线CCT与基线RORA及RORA程度变化呈负相关（P < 0.05）。在调整年龄和性别后，基线时较长的RORA程度预测BCVA恶化≥0.04 /年（优势比[OR]， 3.444； 95%可信区间[CI]， 1.015-11.691; P = 0.047）。在调整年龄和基线RORA程度后，较薄的CCT = 180 μm （OR, 4.684, 95% CI, 1.288-17.036, P = 0.019）、视网膜下结节样沉积（SDDs） （OR, 6.714, 95% CI, 1.555-28.988, P = 0.011）和结节样沉积（OR, 4.392, 95% CI, 1.176-16.410, P = 0.028）和厚脉络膜特征的眼睛（OR, 0.038, 95% CI, 0.003-0.454, P = 0.010）常观察到RORA水平扩展≥175 μm/y （OR, 0.038, 95% CI, 0.003-0.454, P = 0.010）。RORA的垂直延伸也有类似的风险。结论BCVA的变化与RORA和OPL恶化程度的变化是平行的。在基线时RORA较长的眼睛中观察到快速BCVA损伤。脉络膜变薄、SDD和水肿是危险因素，厚脉络膜特征是防止RORA进展的保护因素。为了更好地了解RORA和视力丧失的进展，需要进一步的研究。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。
{"title":"Associations between Progression of Retinal Pigment Epithelial and Outer Retinal Atrophy and Choroidal Thickness: A 2-Year observation","authors":"Norihiro Nagai MD, PhD , Hajime Shinoda MD, PhD , Hisashi Matsubara MD, PhD , Hiroto Terasaki MD, PhD , Takao Hirano MD, PhD , Aki Kato MD, PhD , Akiko Miki MD, PhD , Hiromasa Hirai MD, PhD , Fumiko Murao MD, PhD , Hiroko Imaizumi MD, PhD , Fumi Gomi MD, PhD , Yoshinori Mitamura MD, PhD , Nahoko Ogata MD, PhD , Sentaro Kusuhara MD, PhD , Tsutomu Yasukawa MD, PhD , Toshinori Murata MD, PhD , Taiji Sakamoto MD, PhD , Mineo Kondo MD, PhD , Yoko Ozawa MD, PhD","doi":"10.1016/j.xops.2025.100939","DOIUrl":"10.1016/j.xops.2025.100939","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the clinical course of retinal pigment epithelial and outer retinal atrophy (RORA) with best-corrected visual acuity (BCVA) and risk factors for rapid progression to explore the pathogenesis.</div></div><div><h3>Design</h3><div>Retrospective observational study.</div></div><div><h3>Subjects</h3><div>Data on eyes with fovea-involved RORA associated with age-related macular degeneration were collected over time from 10 hospitals in Japan.</div></div><div><h3>Methods</h3><div>Data on ophthalmic examination, BCVA, and OCT images were analyzed.</div></div><div><h3>Main Outcome Measures</h3><div>Relationships between changes in BCVA and extents of RORA and outer plexiform layer (OPL) deterioration and their associations with central choroidal thickness (CCT) and pachychoroid characteristics at baseline were evaluated.</div></div><div><h3>Results</h3><div>Of the 53 eyes of 53 patients (mean age; 74.9 ± 1.4 years), 32 eyes (60.4%) belonged to men. The progression in the mean extent of OPL deterioration was evident at year 1, whereas that of RORA, BCVA impairment, thinning of the central retinal thickness, and CCT became apparent at year 2 (<em>P</em> < 0.05). Changes in the extents of RORA and OPL deterioration and BCVA were correlated (<em>P</em> < 0.05). Baseline CCT negatively correlated with baseline RORA and the changes in extent of RORA (<em>P</em> < 0.05). After adjusting for age and sex, a longer extent of RORA at baseline predicted BCVA worsening ≥0.04 per year (odds ratio [OR], 3.444; 95% confidence interval [CI], 1.015–11.691; <em>P</em> = 0.047). Greater horizontal extension of RORA ≥175 μm/y was frequently observed in eyes with thinner CCT <180 μm (OR, 4.684; 95% CI, 1.288–17.036; <em>P</em> = 0.019), subretinal drusenoid deposits (SDDs) (OR, 6.714; 95% CI, 1.555–28.988; <em>P</em> = 0.011), and drusen (OR, 4.392; 95% CI, 1.176–16.410; <em>P</em> = 0.028) and less observed in eyes with pachychoroid characteristics (OR, 0.038; 95% CI, 0.003–0.454, <em>P</em> = 0.010) at baseline after adjusting for age and baseline extent of RORA; similar risks for greater vertical extension of RORA were observed.</div></div><div><h3>Conclusions</h3><div>The change in BCVA paralleled the changes in the extents of RORA and OPL deterioration. Rapid BCVA impairment was observed in eyes with longer RORA at baseline. A thinner choroid, SDD, and drusen were risk factors, and pachychoroid characteristics were protective factors against RORA progression. Further studies are warranted to better understand the progression of RORA and vision loss.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100939"},"PeriodicalIF":4.6,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145321054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-10DOI: 10.1016/j.xops.2025.100938
Sumit Garg MD , Eric Donnenfeld MD , John Sheppard MD , Alice Epitropoulos MD , Todd C. Brady MD, PhD
Purpose
The primary objective was to assess the acute efficacy of 0.25% reproxalap ophthalmic solution versus vehicle in patients with dry eye disease.
Design
This was a vehicle-controlled, randomized-sequence, double-masked, 2-period crossover trial.
Participants and Controls
Sixty-three patients with dry eye disease were treated with reproxalap or vehicle in 2 treatment periods.
Methods
For each treatment period, patients were treated 4 times for 1 day, followed the next day by 1 dose before and 1 dose during a 90-minute dry eye chamber. Washout between treatment periods was 7 to 14 days.
Main Outcome Measures
The primary endpoints were ocular redness during the chamber and Schirmer test 10 minutes after the fourth dose on the prechamber day. The key secondary endpoint was ≥10 mm unanesthetized Schirmer test responders. Other secondary endpoints included symptoms in the chamber.
Results
Relative to vehicle, reproxalap treatment statistically significantly diminished ocular redness and increased Schirmer score and percent ≥10-mm responders. All symptoms assessed in the chamber were statistically significantly lower after treatment with reproxalap versus vehicle. The most common adverse event in patients treated with reproxalap was mild transient instillation site irritation, most commonly lasting ≤1 minute.
Conclusions
Within minutes of administration to dry eye disease patients, reproxalap increased tear production, and decreased ocular redness and improved symptoms in a dry eye chamber.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Reproxalap Improves Ocular Redness, Tear Production, and Symptoms in a Pivotal Dry Eye Disease Chamber Trial","authors":"Sumit Garg MD , Eric Donnenfeld MD , John Sheppard MD , Alice Epitropoulos MD , Todd C. Brady MD, PhD","doi":"10.1016/j.xops.2025.100938","DOIUrl":"10.1016/j.xops.2025.100938","url":null,"abstract":"<div><h3>Purpose</h3><div>The primary objective was to assess the acute efficacy of 0.25% reproxalap ophthalmic solution versus vehicle in patients with dry eye disease.</div></div><div><h3>Design</h3><div>This was a vehicle-controlled, randomized-sequence, double-masked, 2-period crossover trial.</div></div><div><h3>Participants and Controls</h3><div>Sixty-three patients with dry eye disease were treated with reproxalap or vehicle in 2 treatment periods.</div></div><div><h3>Methods</h3><div>For each treatment period, patients were treated 4 times for 1 day, followed the next day by 1 dose before and 1 dose during a 90-minute dry eye chamber. Washout between treatment periods was 7 to 14 days.</div></div><div><h3>Main Outcome Measures</h3><div>The primary endpoints were ocular redness during the chamber and Schirmer test 10 minutes after the fourth dose on the prechamber day. The key secondary endpoint was ≥10 mm unanesthetized Schirmer test responders. Other secondary endpoints included symptoms in the chamber.</div></div><div><h3>Results</h3><div>Relative to vehicle, reproxalap treatment statistically significantly diminished ocular redness and increased Schirmer score and percent ≥10-mm responders. All symptoms assessed in the chamber were statistically significantly lower after treatment with reproxalap versus vehicle. The most common adverse event in patients treated with reproxalap was mild transient instillation site irritation, most commonly lasting ≤1 minute.</div></div><div><h3>Conclusions</h3><div>Within minutes of administration to dry eye disease patients, reproxalap increased tear production, and decreased ocular redness and improved symptoms in a dry eye chamber.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100938"},"PeriodicalIF":4.6,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145321224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To evaluate the axial elongation in highly myopic eyes and assess the effects of age, sex, baseline axial length (AL), cataract surgery (CS), pathologic myopia (PM), baseline intraocular pressure (IOP), and genetic risk scores (GRSs).
Design
Retrospective cohort study.
Participants
This study included 614 eyes from 367 individuals with high myopia.
Methods
The study assessed axial elongation rates and their associations with age, sex, baseline AL, CS, PM, and baseline IOP including potential interactions among these factors. Additionally, the study examined whether incorporating GRS improved the predictive model for axial elongation.
Main Outcome Measures
Axial elongation rate in highly myopic eyes.
Results
The study included 367 participants (217 [59.1%] females, 150 [40.9%] males) with a mean age of 58.9 ± 14.4 years and a mean AL of 28.6 ± 2.0 mm. The mean follow-up duration was 4.7 ± 2.7 years, and the average axial elongation rate was 0.031 ± 0.030 mm/year. Cataract surgery was associated with significantly slower axial elongation (P < 0.001). Multivariate analysis revealed that axial elongation increased with age and baseline AL but decreased with CS and an age–AL interaction. The best-fitting model excluded GRS, thus achieving a lower Akaike information criterion score (–573.4) than models including GRS.
Conclusions
Axial elongation persists in highly myopic eyes (0.031 mm/year) but slows over time, owing to baseline AL–age interactions. Genetic risk scores have limited predictive utility in adulthood. This highlights the need for further research on genetic and environmental determinants of myopia progression.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Potential Negative Feedback between Age and Baseline Axial Length on Axial Elongation in High Myopia","authors":"Mariko Murata MD, Masahiro Miyake MD, PhD, MPH, Kenji Suda MD, PhD, Yuki Mori MD, PhD, Kazuya Morino MD, PhD, Wakako Okayama MD, Akitaka Tsujikawa MD, PhD","doi":"10.1016/j.xops.2025.100937","DOIUrl":"10.1016/j.xops.2025.100937","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the axial elongation in highly myopic eyes and assess the effects of age, sex, baseline axial length (AL), cataract surgery (CS), pathologic myopia (PM), baseline intraocular pressure (IOP), and genetic risk scores (GRSs).</div></div><div><h3>Design</h3><div>Retrospective cohort study.</div></div><div><h3>Participants</h3><div>This study included 614 eyes from 367 individuals with high myopia.</div></div><div><h3>Methods</h3><div>The study assessed axial elongation rates and their associations with age, sex, baseline AL, CS, PM, and baseline IOP including potential interactions among these factors. Additionally, the study examined whether incorporating GRS improved the predictive model for axial elongation.</div></div><div><h3>Main Outcome Measures</h3><div>Axial elongation rate in highly myopic eyes.</div></div><div><h3>Results</h3><div>The study included 367 participants (217 [59.1%] females, 150 [40.9%] males) with a mean age of 58.9 ± 14.4 years and a mean AL of 28.6 ± 2.0 mm. The mean follow-up duration was 4.7 ± 2.7 years, and the average axial elongation rate was 0.031 ± 0.030 mm/year. Cataract surgery was associated with significantly slower axial elongation (<em>P</em> < 0.001). Multivariate analysis revealed that axial elongation increased with age and baseline AL but decreased with CS and an age–AL interaction. The best-fitting model excluded GRS, thus achieving a lower Akaike information criterion score (–573.4) than models including GRS.</div></div><div><h3>Conclusions</h3><div>Axial elongation persists in highly myopic eyes (0.031 mm/year) but slows over time, owing to baseline AL–age interactions. Genetic risk scores have limited predictive utility in adulthood. This highlights the need for further research on genetic and environmental determinants of myopia progression.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100937"},"PeriodicalIF":4.6,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145268156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-04DOI: 10.1016/j.xops.2025.100936
Leila Sara Eppenberger MD, MSc , Ezekiel Ze Ken Cheong MD , Joey Chung BSc , Yong Li PhD , Angeline Toh BA , Haoran Cheng BSc , Mark Wong MD , Audrey Chia MD, PhD , Damon Wong PhD , Rachel S. Chong MD, PhD , Leopold Schmetterer PhD , Jost B. Jonas MD, PhD , Marcus Ang MD, PhD
Purpose
To investigate optic nerve head (ONH) changes over 15 years from childhood to adulthood.
Design
A longitudinal study.
Participants
The Atropine Treatment Long-Term Assessment Study (ATLAS) included 148 myopic participants from the Atropine for the Treatment of Myopia 2 (ATOM2) trial.
Methods
During ATOM2, all participants were treated with daily atropine eye drops in concentrations of 0.01%, 0.1%, or 0.5%. The ATLAS recall visit was conducted in 2021–2022. At 3 study visits—ATOM2 baseline, last ATOM2 (5-year), and ATLAS recall (15-year)—participants underwent cycloplegic autorefractometry, biometry, and fundus photography. At recall, OCT centered on the optic disc was additionally performed. Fundus photographs were morphometrically examined for ONH ovality, torsion, parapapillary atrophy (PPA), disc–fovea distance, position of the central retinal vascular trunk (CRVT), angle kappa, and vertical distance between the arterial arcade. OCT images were analyzed for Bruch membrane opening distance, gamma zone, and Bruch membrane overhang.
Main Outcome Measures
Optic nerve head changes from childhood to young adulthood and associated factors.
Results
Optic nerve head characteristics were similar across atropine treatment groups. Myopic refractive error increased from –4.54 ± 1.64 diopters (D) at baseline to –6.35 ± 2.02 D at 5 years to –6.88 ± 2.4 D at 15 years (P < 0.0001). Axial length (AL) increased from a mean of 25.08 ± 0.89 mm to 26.31 ± 1.01 mm (P < 0.0001). Significant ONH changes after 15 years included PPA (beta zone/maximal disc diameter) increasing from 0.19 ± 0.11 to 0.31 ± 0.15 (P < 0.0001), and CRVT position ratio increasing from 1.62 ± 0.22 to 2.23 ± 0.5 (P < 0.0001). Multivariable mixed-effect models confirmed the association of age, AL, and spherical equivalent refraction (SER) with optic disc changes (P < 0.0001). Axial length, SER, and PPA were associated with the Bruch membrane opening distance area and the gamma zone (P values <0.0001). Additionally, age (P < 0.0001), PPA ratio (P = 0.002), and disc–fovea distance ratio (P = 0.030) were found to be associated with myopic progression greater than –2D over a 15-years period.
Conclusions
This long-term study suggests that myopic subjects showed increased PPA and nasal CRVT shift from childhood into young adulthood.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Optic Nerve Head Changes over 15 Years—From the Atropine Treatment Long-Term Assessment Study","authors":"Leila Sara Eppenberger MD, MSc , Ezekiel Ze Ken Cheong MD , Joey Chung BSc , Yong Li PhD , Angeline Toh BA , Haoran Cheng BSc , Mark Wong MD , Audrey Chia MD, PhD , Damon Wong PhD , Rachel S. Chong MD, PhD , Leopold Schmetterer PhD , Jost B. Jonas MD, PhD , Marcus Ang MD, PhD","doi":"10.1016/j.xops.2025.100936","DOIUrl":"10.1016/j.xops.2025.100936","url":null,"abstract":"<div><h3>Purpose</h3><div>To investigate optic nerve head (ONH) changes over 15 years from childhood to adulthood.</div></div><div><h3>Design</h3><div>A longitudinal study.</div></div><div><h3>Participants</h3><div>The Atropine Treatment Long-Term Assessment Study (ATLAS) included 148 myopic participants from the Atropine for the Treatment of Myopia 2 (ATOM2) trial.</div></div><div><h3>Methods</h3><div>During ATOM2, all participants were treated with daily atropine eye drops in concentrations of 0.01%, 0.1%, or 0.5%. The ATLAS recall visit was conducted in 2021–2022. At 3 study visits—ATOM2 baseline, last ATOM2 (5-year), and ATLAS recall (15-year)—participants underwent cycloplegic autorefractometry, biometry, and fundus photography. At recall, OCT centered on the optic disc was additionally performed. Fundus photographs were morphometrically examined for ONH ovality, torsion, parapapillary atrophy (PPA), disc–fovea distance, position of the central retinal vascular trunk (CRVT), angle kappa, and vertical distance between the arterial arcade. OCT images were analyzed for Bruch membrane opening distance, gamma zone, and Bruch membrane overhang.</div></div><div><h3>Main Outcome Measures</h3><div>Optic nerve head changes from childhood to young adulthood and associated factors.</div></div><div><h3>Results</h3><div>Optic nerve head characteristics were similar across atropine treatment groups. Myopic refractive error increased from –4.54 ± 1.64 diopters (D) at baseline to –6.35 ± 2.02 D at 5 years to –6.88 ± 2.4 D at 15 years (<em>P</em> < 0.0001). Axial length (AL) increased from a mean of 25.08 ± 0.89 mm to 26.31 ± 1.01 mm (<em>P</em> < 0.0001). Significant ONH changes after 15 years included PPA (beta zone/maximal disc diameter) increasing from 0.19 ± 0.11 to 0.31 ± 0.15 (<em>P</em> < 0.0001), and CRVT position ratio increasing from 1.62 ± 0.22 to 2.23 ± 0.5 (<em>P</em> < 0.0001). Multivariable mixed-effect models confirmed the association of age, AL, and spherical equivalent refraction (SER) with optic disc changes (<em>P</em> < 0.0001). Axial length, SER, and PPA were associated with the Bruch membrane opening distance area and the gamma zone (<em>P</em> values <0.0001). Additionally, age (<em>P</em> < 0.0001), PPA ratio (<em>P</em> = 0.002), and disc–fovea distance ratio (<em>P</em> = 0.030) were found to be associated with myopic progression greater than –2D over a 15-years period.</div></div><div><h3>Conclusions</h3><div>This long-term study suggests that myopic subjects showed increased PPA and nasal CRVT shift from childhood into young adulthood.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100936"},"PeriodicalIF":4.6,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145321222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-03DOI: 10.1016/j.xops.2025.100935
Clare W. Teng MD , Saawan D. Patel BS , Andrew J. Barkmeier MD , T.Y. Alvin Liu MD , David Myung MD, PhD , Jeffrey Henderer MD , James Liu MD , Eric Hansen MD , Lama A. Al-Aswad MD, MPH
Purpose
Artificial intelligence (AI)–aided diabetic retinopathy (DR) testing systems have been commercialized for 5 years, but adoption is still relatively limited. This article aims to summarize the evidence in clinical settings, describe the current state of adoption, and share themes of successful implementation.
Design
Evaluation of diagnostic test or technology.
Participants
Ophthalmologists.
Methods
We performed literature review and conducted interviews with ophthalmologists leading implementation of AI-aided DR testing programs at several academic health systems. The study focused on the 3 currently US Food and Drug Administration-cleared AI systems: LumineticsCore, EyeArt, and AEYE Diagnostic Screening (AEYE-DS), assessing their performance and strategies utilized by health systems to effectively implement this technology in clinics.
The literature review found 6 publications reporting diagnostic accuracy data of autonomous AI DR testing in primary care office settings, including 5 for LumineticsCore and 1 for EyeArt. Additional articles, of which 18 were selected for detailed review, addressed impact on patient adherence, health equity, and carbon footprint, as well as cost-effectiveness and workflow efficiency analyses. There were no studies comparing the systems on the same patients. In aggregate, adopters of the AI systems reported average nonmydriatic gradability of 49% to 75% (n = 5), sensitivity 87% to 100% (n = 3), and specificity 60% to 91% (n = 4). Based on public records at the time of writing, both LumineticsCore and EyeArt have >5 academic adopters in the United States. Limited information is available on AEYE-DS given recency of regulatory clearance. Elements of successful implementation include proper site selection, aligning AI tools with primary care clinic workflows, streamlining patient engagement and referrals, and ongoing training of staff. Health systems utilizing AI reported improved Healthcare Effectiveness Data and Information Set measures, health equity, productivity, and patient adherence to follow-up with ophthalmology.
Conclusions
Artificial intelligence–aided diabetic eye examinations present a promising solution to facilitate early detection of DR, promote equitable access, and drive down system-level cost of care. Its successful implementation requires addressing technological, operational, and stakeholder engagement challenges. Our study underscores the potential of AI to revolutionize care delivery provided its adoption is strategically managed.
Financial Disclosure(s)
The author has no/the authors have no proprietary or commercial interest in any materials discussed in this article.
{"title":"Autonomous Artificial Intelligence in Diabetic Retinopathy Testing—Lessons Learned on Successful Health System Adoption","authors":"Clare W. Teng MD , Saawan D. Patel BS , Andrew J. Barkmeier MD , T.Y. Alvin Liu MD , David Myung MD, PhD , Jeffrey Henderer MD , James Liu MD , Eric Hansen MD , Lama A. Al-Aswad MD, MPH","doi":"10.1016/j.xops.2025.100935","DOIUrl":"10.1016/j.xops.2025.100935","url":null,"abstract":"<div><h3>Purpose</h3><div>Artificial intelligence (AI)–aided diabetic retinopathy (DR) testing systems have been commercialized for 5 years, but adoption is still relatively limited. This article aims to summarize the evidence in clinical settings, describe the current state of adoption, and share themes of successful implementation.</div></div><div><h3>Design</h3><div>Evaluation of diagnostic test or technology.</div></div><div><h3>Participants</h3><div>Ophthalmologists.</div></div><div><h3>Methods</h3><div>We performed literature review and conducted interviews with ophthalmologists leading implementation of AI-aided DR testing programs at several academic health systems. The study focused on the 3 currently US Food and Drug Administration-cleared AI systems: LumineticsCore, EyeArt, and AEYE Diagnostic Screening (AEYE-DS), assessing their performance and strategies utilized by health systems to effectively implement this technology in clinics.</div></div><div><h3>Main Outcome Measures</h3><div>Diagnostic accuracy data, ophthalmologist feedback.</div></div><div><h3>Results</h3><div>The literature review found 6 publications reporting diagnostic accuracy data of autonomous AI DR testing in primary care office settings, including 5 for LumineticsCore and 1 for EyeArt. Additional articles, of which 18 were selected for detailed review, addressed impact on patient adherence, health equity, and carbon footprint, as well as cost-effectiveness and workflow efficiency analyses. There were no studies comparing the systems on the same patients. In aggregate, adopters of the AI systems reported average nonmydriatic gradability of 49% to 75% (n = 5), sensitivity 87% to 100% (n = 3), and specificity 60% to 91% (n = 4). Based on public records at the time of writing, both LumineticsCore and EyeArt have >5 academic adopters in the United States. Limited information is available on AEYE-DS given recency of regulatory clearance. Elements of successful implementation include proper site selection, aligning AI tools with primary care clinic workflows, streamlining patient engagement and referrals, and ongoing training of staff. Health systems utilizing AI reported improved Healthcare Effectiveness Data and Information Set measures, health equity, productivity, and patient adherence to follow-up with ophthalmology.</div></div><div><h3>Conclusions</h3><div>Artificial intelligence–aided diabetic eye examinations present a promising solution to facilitate early detection of DR, promote equitable access, and drive down system-level cost of care. Its successful implementation requires addressing technological, operational, and stakeholder engagement challenges. Our study underscores the potential of AI to revolutionize care delivery provided its adoption is strategically managed.</div></div><div><h3>Financial Disclosure(s)</h3><div>The author has no/the authors have no proprietary or commercial interest in any materials discussed in this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100935"},"PeriodicalIF":4.6,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145321225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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