Pub Date : 2025-11-26DOI: 10.1016/j.xops.2025.101017
Christina Y. Weng MD, MBA, Kevin J. Blinder MD, Edward F. Hall MD, William N. Rosenthal MD
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Pub Date : 2025-11-26DOI: 10.1016/j.xops.2025.101020
Sifan Zhang , Ziyi You MS , Bernard Rosner PhD , Gui-shuang Ying PhD
Purpose
To evaluate the performance of various analysis approaches for skewed correlated eye data from 2 eyes of a subject in the same comparison group, which is common in ophthalmology and vision research.
Design
Simulation study and real data analysis.
Subjects
Simulated subjects and participants of the Dry Eye Assessment and Management (DREAM) study.
Methods
We simulated skewed correlated data using (skewness, kurtosis) = (27, 50) and (0.06, 5.9), intereye correlation (ρ = 0, 0.25, 0.50, and 0.75), sample sizes (n = 20, 50, 100, and 200), and mean differences between 2 groups (0 for type 1 error rate, 0.2 for statistical power). Each simulated data set was analyzed without and with applying rank-based normalization: (1) 2-sample t test of 2 eye data; (2) 2-sample t test of random eye data; (3) Wald test from generalized estimating equations (GEE Wald); (4) GEE score test (GEE score); (5) F-test from linear mixed effects model (LMM); (6) clustered Wilcoxon test of Rosner, Glynn, and Lee; (7) clustered Wilcoxon test of Datta and Satten; (8) Wilcoxon rank sum test of 2 eyes ignoring intereye correlation; and (9) Wilcoxon rank sum test on average of 2 eyes. We demonstrated analysis of skewed tear break-up time (TBUT) data from the DREAM study.
Main Outcome Measures
Type 1 error rate and statistical power.
Results
T test and Wilcoxon test on 2 eye data without accounting for intereye correlation inflated type 1 error rate up to 0.13, and GEE Wald inflated type 1 error rate to 0.08 when sample size is small, whereas all other tests maintained type 1 error rate close to 0.05. For skewed data without normalization, t test of random eye, GEE Wald, GEE score, and LMM had substantially lower power than clustered Wilcoxon methods. After normalization, GEE score and LMM achieved similar or slightly higher power than clustered Wilcoxon methods. Results from analysis of TBUT are consistent with simulation findings.
Conclusions
When comparing skewed correlated eye measures between 2 groups of subjects with their 2 eyes in the same comparison group, clustered Wilcoxon methods can be used. Alternatively, skewed data can be normalized before applying GEE score or LMM, which may achieve slightly higher statistical power than clustered Wilcoxon methods and offers flexibility to adjust for other covariates.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Evaluation of Statistical Methods for Clustered Eye Data with Skewed Distribution","authors":"Sifan Zhang , Ziyi You MS , Bernard Rosner PhD , Gui-shuang Ying PhD","doi":"10.1016/j.xops.2025.101020","DOIUrl":"10.1016/j.xops.2025.101020","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the performance of various analysis approaches for skewed correlated eye data from 2 eyes of a subject in the same comparison group, which is common in ophthalmology and vision research.</div></div><div><h3>Design</h3><div>Simulation study and real data analysis.</div></div><div><h3>Subjects</h3><div>Simulated subjects and participants of the Dry Eye Assessment and Management (DREAM) study.</div></div><div><h3>Methods</h3><div>We simulated skewed correlated data using (skewness, kurtosis) = (27, 50) and (0.06, 5.9), intereye correlation (<em>ρ</em> = 0, 0.25, 0.50, and 0.75), sample sizes (<em>n</em> = 20, 50, 100, and 200), and mean differences between 2 groups (0 for type 1 error rate, 0.2 for statistical power). Each simulated data set was analyzed without and with applying rank-based normalization: (1) 2-sample <em>t</em> test of 2 eye data; (2) 2-sample <em>t</em> test of random eye data; (3) Wald test from generalized estimating equations (GEE Wald); (4) GEE score test (GEE score); (5) <em>F</em>-test from linear mixed effects model (LMM); (6) clustered Wilcoxon test of Rosner, Glynn, and Lee; (7) clustered Wilcoxon test of Datta and Satten; (8) Wilcoxon rank sum test of 2 eyes ignoring intereye correlation; and (9) Wilcoxon rank sum test on average of 2 eyes. We demonstrated analysis of skewed tear break-up time (TBUT) data from the DREAM study.</div></div><div><h3>Main Outcome Measures</h3><div>Type 1 error rate and statistical power.</div></div><div><h3>Results</h3><div><em>T</em> test and Wilcoxon test on 2 eye data without accounting for intereye correlation inflated type 1 error rate up to 0.13, and GEE Wald inflated type 1 error rate to 0.08 when sample size is small, whereas all other tests maintained type 1 error rate close to 0.05. For skewed data without normalization, <em>t</em> test of random eye, GEE Wald, GEE score, and LMM had substantially lower power than clustered Wilcoxon methods. After normalization, GEE score and LMM achieved similar or slightly higher power than clustered Wilcoxon methods. Results from analysis of TBUT are consistent with simulation findings.</div></div><div><h3>Conclusions</h3><div>When comparing skewed correlated eye measures between 2 groups of subjects with their 2 eyes in the same comparison group, clustered Wilcoxon methods can be used. Alternatively, skewed data can be normalized before applying GEE score or LMM, which may achieve slightly higher statistical power than clustered Wilcoxon methods and offers flexibility to adjust for other covariates.</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 2","pages":"Article 101020"},"PeriodicalIF":4.6,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145884506","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 : 2025-11-26DOI: 10.1016/j.xops.2025.101021
Jeroen A.A.H. Pas MD , Patty P.A. Dhooge MD, PhD , Catherina H.Z. Li MD , Rob W.J. Collin PhD , Carel B. Hoyng MD, PhD , Joanna IntHout PhD
Objective
Designing a clinical trial for rare diseases such as Stargardt disease type 1 is challenging due to the limited patient population. In traditional clinical trial designs for inherited retinal diseases, often only 1 eye of each patient is used as the treated eye or the sham, disregarding half of the available eyes.
This study explores a trial design in which both eyes are included, with the fellow eye serving as the control, maximizing the use of available data and enhancing statistical power.
Design
Retrospective analysis of natural history data to conduct sample size calculations.
Participants
Patients with genetically solved Stargardt disease type 1 who had at least 2 fundus autofluorescence measurements obtained within 5 years of each other. Retrospective data of 164 patients were included for analysis.
Methods
The required sample sizes for 1-eye and paired-eye study designs were calculated using retrospective natural history data on the progression of definitely decreased autofluorescence quantified from fundus autofluorescence imaging.
Main Outcome Measures
Required sample size for a clinical trial.
Results
Sample size calculations showed that 170 patients are needed for a 2-year clinical trial with a 1-eye design, decreasing to 99 patients for a 5-year trial. When using a paired-eye design, 64 patients are needed in a 2-year trial, decreasing to 28 patients in a 5-year trial. When using a paired-eye design and requiring definitely decreased autofluorescence atrophy in both eyes at inclusion, 37 patients were needed in a 2-year trial, decreasing to 16 patients in a 5-year trial.
Conclusions
Using a paired-eye design for a clinical trial in Stargardt disease type 1, with definitely decreased autofluorescence atrophy growth rate as the primary end point, is more efficient than a 1-eye design. Implementing additional inclusion criteria, such as requiring definitely decreased autofluorescence atrophy in both eyes at baseline, further reduces the number of patients needed to achieve sufficient statistical power. This approach enhances the feasibility for trials in Stargardt disease type 1 where patient availability is limited.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"A Comparison of Randomizing Either One Eye or Both Eyes in Clinical Trials for Stargardt Disease Type 1","authors":"Jeroen A.A.H. Pas MD , Patty P.A. Dhooge MD, PhD , Catherina H.Z. Li MD , Rob W.J. Collin PhD , Carel B. Hoyng MD, PhD , Joanna IntHout PhD","doi":"10.1016/j.xops.2025.101021","DOIUrl":"10.1016/j.xops.2025.101021","url":null,"abstract":"<div><h3>Objective</h3><div>Designing a clinical trial for rare diseases such as Stargardt disease type 1 is challenging due to the limited patient population. In traditional clinical trial designs for inherited retinal diseases, often only 1 eye of each patient is used as the treated eye or the sham, disregarding half of the available eyes.</div><div>This study explores a trial design in which both eyes are included, with the fellow eye serving as the control, maximizing the use of available data and enhancing statistical power.</div></div><div><h3>Design</h3><div>Retrospective analysis of natural history data to conduct sample size calculations.</div></div><div><h3>Participants</h3><div>Patients with genetically solved Stargardt disease type 1 who had at least 2 fundus autofluorescence measurements obtained within 5 years of each other. Retrospective data of 164 patients were included for analysis.</div></div><div><h3>Methods</h3><div>The required sample sizes for 1-eye and paired-eye study designs were calculated using retrospective natural history data on the progression of definitely decreased autofluorescence quantified from fundus autofluorescence imaging.</div></div><div><h3>Main Outcome Measures</h3><div>Required sample size for a clinical trial.</div></div><div><h3>Results</h3><div>Sample size calculations showed that 170 patients are needed for a 2-year clinical trial with a 1-eye design, decreasing to 99 patients for a 5-year trial. When using a paired-eye design, 64 patients are needed in a 2-year trial, decreasing to 28 patients in a 5-year trial. When using a paired-eye design and requiring definitely decreased autofluorescence atrophy in both eyes at inclusion, 37 patients were needed in a 2-year trial, decreasing to 16 patients in a 5-year trial.</div></div><div><h3>Conclusions</h3><div>Using a paired-eye design for a clinical trial in Stargardt disease type 1, with definitely decreased autofluorescence atrophy growth rate as the primary end point, is more efficient than a 1-eye design. Implementing additional inclusion criteria, such as requiring definitely decreased autofluorescence atrophy in both eyes at baseline, further reduces the number of patients needed to achieve sufficient statistical power. This approach enhances the feasibility for trials in Stargardt disease type 1 where patient availability is limited.</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 2","pages":"Article 101021"},"PeriodicalIF":4.6,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145925895","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 : 2025-11-26DOI: 10.1016/j.xops.2025.101014
David Mikhail MD(C), MSc , Shuting Xie MSc , Michael Balas MD , Jason M. Kwok MD , Ana Miguel MD, PhD , Amrit Rai MD , Amandeep Rai MD , Peter J. Kertes MD , Iqbal Ike K. Ahmed MD , Matthew B. Schlenker MD, MSc
Purpose
To objectively quantify the motion paths of surgical instruments during cataract surgery across a resident’s training, identifying patterns of skill acquisition and proficiency development.
Design
An n = 1 panel study.
Subjects
One ophthalmology resident performing cataract surgery.
Methods
One hundred cataract surgery videos performed by a single resident from their sixth to 760th case were collected. Advanced motion tracking software (Computer Vision Annotation Tool) was utilized to annotate and track the trajectories of 11 surgical instruments on a frame-by-frame basis. Monotonic trends were assessed using the Mann–Kendall test and Theil–Sen slope estimation, with Spearman correlation measuring the association between case number and performance metric values. Pettitt change-point analysis identified significant transitions in the resident’s skill progression.
Main Outcome Measures
Six key motion parameters, including total path length, average velocity, average acceleration, root mean square jerk, average angular change, and workspace coverage, were extracted for each instrument in each video.
Results
All 11 instruments demonstrated statistically significant reductions in ≥1 motion parameter. Path length consistently decreased across training, with the largest reductions seen in the cannula (–11.8%; 95% confidence interval [CI], –17.4% to –6.8%; P < 0.001), phacoemulsification handpiece (–11.5%; 95% CI, –14.1% to –8.7%; P < 0.001), and cystotome (–8.9%; 95% CI, –11.8% to –5.9%; P < 0.001). The intraocular lens inserter showed the greatest reduction in average angular change of 3.0% (–1.70°) (95% CI, –3.9% to –2.0%; P < 0.001). Pettitt analysis demonstrated significant shifts in surgical efficiency at around case 300 for most instruments, although improvements in certain advanced tasks (e.g., lens implantation) emerged later.
Conclusions
This large-scale, frame-by-frame motion tracking study revealed distinct instrument- and task-specific learning curves in cataract surgery, highlighting progressive changes in motion metrics over time. A significant shift at approximately case 300 marked a milestone in the resident’s instrument use patterns. These findings underscore the potential of objective, video-based motion tracking analytics to provide data-driven resident feedback, guiding targeted instruction and standardizing cataract surgery training.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Quantitative Analysis of Instrument Motion Paths in Cataract Surgery across a Resident’s Training","authors":"David Mikhail MD(C), MSc , Shuting Xie MSc , Michael Balas MD , Jason M. Kwok MD , Ana Miguel MD, PhD , Amrit Rai MD , Amandeep Rai MD , Peter J. Kertes MD , Iqbal Ike K. Ahmed MD , Matthew B. Schlenker MD, MSc","doi":"10.1016/j.xops.2025.101014","DOIUrl":"10.1016/j.xops.2025.101014","url":null,"abstract":"<div><h3>Purpose</h3><div>To objectively quantify the motion paths of surgical instruments during cataract surgery across a resident’s training, identifying patterns of skill acquisition and proficiency development.</div></div><div><h3>Design</h3><div>An <em>n</em> = 1 panel study.</div></div><div><h3>Subjects</h3><div>One ophthalmology resident performing cataract surgery.</div></div><div><h3>Methods</h3><div>One hundred cataract surgery videos performed by a single resident from their sixth to 760th case were collected. Advanced motion tracking software (Computer Vision Annotation Tool) was utilized to annotate and track the trajectories of 11 surgical instruments on a frame-by-frame basis. Monotonic trends were assessed using the Mann–Kendall test and Theil–Sen slope estimation, with Spearman correlation measuring the association between case number and performance metric values. Pettitt change-point analysis identified significant transitions in the resident’s skill progression.</div></div><div><h3>Main Outcome Measures</h3><div>Six key motion parameters, including total path length, average velocity, average acceleration, root mean square jerk, average angular change, and workspace coverage, were extracted for each instrument in each video.</div></div><div><h3>Results</h3><div>All 11 instruments demonstrated statistically significant reductions in ≥1 motion parameter. Path length consistently decreased across training, with the largest reductions seen in the cannula (–11.8%; 95% confidence interval [CI], –17.4% to –6.8%; <em>P</em> < 0.001), phacoemulsification handpiece (–11.5%; 95% CI, –14.1% to –8.7%; <em>P</em> < 0.001), and cystotome (–8.9%; 95% CI, –11.8% to –5.9%; <em>P</em> < 0.001). The intraocular lens inserter showed the greatest reduction in average angular change of 3.0% (–1.70°) (95% CI, –3.9% to –2.0%; <em>P</em> < 0.001). Pettitt analysis demonstrated significant shifts in surgical efficiency at around case 300 for most instruments, although improvements in certain advanced tasks (e.g., lens implantation) emerged later.</div></div><div><h3>Conclusions</h3><div>This large-scale, frame-by-frame motion tracking study revealed distinct instrument- and task-specific learning curves in cataract surgery, highlighting progressive changes in motion metrics over time. A significant shift at approximately case 300 marked a milestone in the resident’s instrument use patterns. These findings underscore the potential of objective, video-based motion tracking analytics to provide data-driven resident feedback, guiding targeted instruction and standardizing cataract surgery training.</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 2","pages":"Article 101014"},"PeriodicalIF":4.6,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145884503","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 : 2025-11-25DOI: 10.1016/j.xops.2025.101022
Minali Prasad BA, Susan Vitale PhD, Elvira Agrón MA, Thilaka Arunachalam MD, Emily Y. Chew MD
Objective
To examine for change in vision-related quality of life before and after geographic atrophy (GA) development.
Design
A post hoc analysis of a prospective randomized clinical trial.
Participants
Age-Related Eye Disease Study (AREDS) participants with ≥2 study visits 1 year apart at which they completed the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and age-related macular degeneration (AMD) severity gradings available at the VFQ visits.
Methods
A masked reading center assessed AMD severity using annual color fundus photographs. Regression spline models with random effects for time and eye-within-participant (SAS 9.4) were used to compare the rate of change in quality of life (difference in slope for each of the 4 quality of life measures) before and after development of GA (with separate models for GA subtypes: central GA [CGA], noncentral GA [NCGA], and any GA). Models were adjusted for age and visual acuity. If neovascular AMD developed after a GA outcome, we censored the subsequent observations.
Main Outcome Measures
Outcomes included the VFQ composite score calculated as an average score of nonmissing answered items. The method of successive dichotomizations was used to estimate person measures for the overall NEI VFQ-25 and for 2 derived subscales: visual functioning and social-emotional functioning.
Results
Among AREDS participants with NEI VFQ-25 data available, 358 eyes (298 participants) developed any GA. None of the quality of life measures differed significantly pre- and post-CGA. Rasch-calibrated subscale score for visual function and composite scores declined more quickly after NCGA (difference in slope [post minus pre]: –0.10 logit/yr [95% confidence interval: –0.18, –0.01], P = 0.03; –0.78 points/yr [95% confidence interval: –1.47, –0.08], P = 0.03, respectively) and after any GA (–0.09 logit/yr [95% confidence interval: –0.16, –0.01], P = 0.02; –0.68 points/yr [95% confidence interval: –1.29, –0.07], P = 0.03, respectively).
Conclusions
We observed worsening quality of life after development of NCGA and any GA in AREDS participants across several quality of life measures. Development of CGA was not associated with any significant changes in the quality of life measures, possibly due to the smaller sample size and limited power. Our findings highlight the importance of examining the relationship between GA subtypes and different indices of quality of life.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Changes in Vision-Related Quality of Life before and after Geographic Atrophy Development in Age-Related Eye Disease Study Participants","authors":"Minali Prasad BA, Susan Vitale PhD, Elvira Agrón MA, Thilaka Arunachalam MD, Emily Y. Chew MD","doi":"10.1016/j.xops.2025.101022","DOIUrl":"10.1016/j.xops.2025.101022","url":null,"abstract":"<div><h3>Objective</h3><div>To examine for change in vision-related quality of life before and after geographic atrophy (GA) development.</div></div><div><h3>Design</h3><div>A post hoc analysis of a prospective randomized clinical trial.</div></div><div><h3>Participants</h3><div>Age-Related Eye Disease Study (AREDS) participants with ≥2 study visits 1 year apart at which they completed the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and age-related macular degeneration (AMD) severity gradings available at the VFQ visits.</div></div><div><h3>Methods</h3><div>A masked reading center assessed AMD severity using annual color fundus photographs. Regression spline models with random effects for time and eye-within-participant (SAS 9.4) were used to compare the rate of change in quality of life (difference in slope for each of the 4 quality of life measures) before and after development of GA (with separate models for GA subtypes: central GA [CGA], noncentral GA [NCGA], and any GA). Models were adjusted for age and visual acuity. If neovascular AMD developed after a GA outcome, we censored the subsequent observations.</div></div><div><h3>Main Outcome Measures</h3><div>Outcomes included the VFQ composite score calculated as an average score of nonmissing answered items. The method of successive dichotomizations was used to estimate person measures for the overall NEI VFQ-25 and for 2 derived subscales: visual functioning and social-emotional functioning.</div></div><div><h3>Results</h3><div>Among AREDS participants with NEI VFQ-25 data available, 358 eyes (298 participants) developed any GA. None of the quality of life measures differed significantly pre- and post-CGA. Rasch-calibrated subscale score for visual function and composite scores declined more quickly after NCGA (difference in slope [post minus pre]: –0.10 logit/yr [95% confidence interval: –0.18, –0.01], <em>P</em> = 0.03; –0.78 points/yr [95% confidence interval: –1.47, –0.08], <em>P</em> = 0.03, respectively) and after any GA (–0.09 logit/yr [95% confidence interval: –0.16, –0.01], <em>P</em> = 0.02; –0.68 points/yr [95% confidence interval: –1.29, –0.07], <em>P</em> = 0.03, respectively).</div></div><div><h3>Conclusions</h3><div>We observed worsening quality of life after development of NCGA and any GA in AREDS participants across several quality of life measures. Development of CGA was not associated with any significant changes in the quality of life measures, possibly due to the smaller sample size and limited power. Our findings highlight the importance of examining the relationship between GA subtypes and different indices of quality of life.</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 2","pages":"Article 101022"},"PeriodicalIF":4.6,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145884502","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 : 2025-11-24DOI: 10.1016/j.xops.2025.101018
Jason Charng PhD , David Alonso-Caneiro PhD , Tina M. Lamey PhD , Jennifer A. Thompson PhD , Jeremiah K.H. Lim PhD , Elaine Ong MD , Terri L. McLaren BS , Fred K. Chen PhD, FRANZCO
Purpose
To compare microperimetry progression rate in USH2A-retinopathy using prespecified points based on fundus autofluorescence coregistration with loci preselected based on retinal sensitivity profile.
Design
Cohort longitudinal study.
Subjects
Seventeen eyes from 17 patients with biallelic pathogenic variants in USH2A gene.
Methods
Microperimetry was recorded using 10-2 grid. The grid was partitioned into 68 2° × 2° nonoverlapping squares, representing the retinal coverage of each locus. Four metrics were defined at baseline: (1) mean macular sensitivity (MMS): average sensitivity of all loci; (2) edge of scotoma sensitivity (ESS): average sensitivity of all loci adjacent to a scotomatous loci at baseline; (3) modified Rate of Progression in USH2A-related Retinal Degeneration study-defined functional transitional point (mFTP): selection based on ranking of the proportion peripheral adjacent loci that showed ≥7 decibel (dB) decrease; and (4) hyperautofluorescent ring sensitivity (HRS): average sensitivity of stimulus squares which the hyperautofluorescent ring boundary transects into. Trend-based progression rates (gradient from linear regression) were compared between these metrics, and event-based analysis of the US Food and Drug Administration-defined clinically significant change in visual field (mean change of ≥7 dB across ≥5 prespecified loci).
Main Outcome Measures
Trend- and event-based measures in MMS, ESS, mFTP, and HRS.
Results
Seventeen patients (median age 37.0 years) had mean baseline values of 9.7 dB, 9.2 dB, 17.9 dB, and 13.1 dB for MMS, ESS, mFTP, and HRS, respectively. Using all longitudinal data (mean follow-up 4.0 years), trend analysis showed mFTP progression rate (–1.53 ± 1.37 dB/year) was significantly faster than MMS (–0.51 ± 0.63 dB/year) and ESS (–1.11 ± 1.23 dB/year) but similar to HRS (–1.29 ± 1.41 dB/year). Edge of scotoma sensitivity was more prone to floor effect and had lower baseline sensitivity than mFTP and HRS. In event-based analysis, the proportion of eyes that demonstrated clinically significant mean change was similar between ESS (2-year 36.4%, overall 45.5%), mFTP (2-year 33.3%, overall 43.8%), and HRS (2-year 28.5%, overall 42.9%) but noticeable less in MMS (2-year 13.3%, overall 12.5%).
Conclusions
Hyperautofluorescent ring sensitivity and mFTP showed comparable performance in both trend- and event-based analyses, superior to that of MMS and ESS. Additional advantage of mFTP is inclusion of patients without the autofluorescent ring.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的比较基于眼底自身荧光共配的预先指定点与基于视网膜敏感性谱的预先选择位点在ush2a视网膜病变中的显微视野检查进展率。设计:队列纵向研究。研究对象:17例USH2A基因双等位致病变异患者的17只眼。方法采用10-2栅格法记录显微视野。网格被划分为68个2°× 2°不重叠的正方形,代表每个位点的视网膜覆盖范围。基线时定义了四个指标:(1)平均黄斑灵敏度(MMS):所有位点的平均灵敏度;(2)暗点边缘灵敏度(edge of scotoma sensitivity, ESS):暗点附近所有基因座在基线处的平均灵敏度;(3) ush2a相关视网膜变性研究定义的功能过渡点(mFTP)的改进进展率:根据显示≥7分贝(dB)下降的周围邻近基因座比例排序进行选择;(4)超自荧光环灵敏度(HRS):超自荧光环边界横过的刺激方的平均灵敏度。基于趋势的进展率(线性回归的梯度)与美国食品和药物管理局定义的视野临床显著变化的基于事件的分析(≥5个预先指定的位点的平均变化≥7 dB)之间进行比较。主要结果测量MMS、ESS、mFTP和HRS中基于趋势和事件的测量。结果17例患者(中位年龄37.0岁)MMS、ESS、mFTP和HRS的平均基线值分别为9.7 dB、9.2 dB、17.9 dB和13.1 dB。使用所有纵向数据(平均随访4.0年),趋势分析显示mFTP进展率(-1.53±1.37 dB/年)显著快于MMS(-0.51±0.63 dB/年)和ESS(-1.11±1.23 dB/年),但与HRS相似(-1.29±1.41 dB/年)。暗点边缘敏感度较mFTP和HRS更易受地板效应影响,基线敏感度较低。在基于事件的分析中,在ESS(2年36.4%,总体45.5%)、mFTP(2年33.3%,总体43.8%)和HRS(2年28.5%,总体42.9%)中表现出临床显著平均变化的眼睛比例相似,但在MMS中明显较少(2年13.3%,总体12.5%)。结论shyperautofluorescence ring sensitivity和mFTP在基于趋势和事件的分析中表现相当,优于MMS和ESS。mFTP的另一个优点是包括没有自动荧光环的患者。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":"Anatomy- versus Sensitivity-Based Loci Preselection in Detecting USH2A-Retinopathy Microperimetric Progression","authors":"Jason Charng PhD , David Alonso-Caneiro PhD , Tina M. Lamey PhD , Jennifer A. Thompson PhD , Jeremiah K.H. Lim PhD , Elaine Ong MD , Terri L. McLaren BS , Fred K. Chen PhD, FRANZCO","doi":"10.1016/j.xops.2025.101018","DOIUrl":"10.1016/j.xops.2025.101018","url":null,"abstract":"<div><h3>Purpose</h3><div>To compare microperimetry progression rate in <em>USH2A-</em>retinopathy using prespecified points based on fundus autofluorescence coregistration with loci preselected based on retinal sensitivity profile.</div></div><div><h3>Design</h3><div>Cohort longitudinal study.</div></div><div><h3>Subjects</h3><div>Seventeen eyes from 17 patients with biallelic pathogenic variants in <em>USH2A</em> gene.</div></div><div><h3>Methods</h3><div>Microperimetry was recorded using 10-2 grid. The grid was partitioned into 68 2° × 2° nonoverlapping squares, representing the retinal coverage of each locus. Four metrics were defined at baseline: (1) mean macular sensitivity (MMS): average sensitivity of all loci; (2) edge of scotoma sensitivity (ESS): average sensitivity of all loci adjacent to a scotomatous loci at baseline; (3) modified Rate of Progression in <em>USH2A</em>-related Retinal Degeneration study-defined functional transitional point (mFTP): selection based on ranking of the proportion peripheral adjacent loci that showed ≥7 decibel (dB) decrease; and (4) hyperautofluorescent ring sensitivity (HRS): average sensitivity of stimulus squares which the hyperautofluorescent ring boundary transects into. Trend-based progression rates (gradient from linear regression) were compared between these metrics, and event-based analysis of the US Food and Drug Administration-defined clinically significant change in visual field (mean change of ≥7 dB across ≥5 prespecified loci).</div></div><div><h3>Main Outcome Measures</h3><div>Trend- and event-based measures in MMS, ESS, mFTP, and HRS.</div></div><div><h3>Results</h3><div>Seventeen patients (median age 37.0 years) had mean baseline values of 9.7 dB, 9.2 dB, 17.9 dB, and 13.1 dB for MMS, ESS, mFTP, and HRS, respectively. Using all longitudinal data (mean follow-up 4.0 years), trend analysis showed mFTP progression rate (–1.53 ± 1.37 dB/year) was significantly faster than MMS (–0.51 ± 0.63 dB/year) and ESS (–1.11 ± 1.23 dB/year) but similar to HRS (–1.29 ± 1.41 dB/year). Edge of scotoma sensitivity was more prone to floor effect and had lower baseline sensitivity than mFTP and HRS. In event-based analysis, the proportion of eyes that demonstrated clinically significant mean change was similar between ESS (2-year 36.4%, overall 45.5%), mFTP (2-year 33.3%, overall 43.8%), and HRS (2-year 28.5%, overall 42.9%) but noticeable less in MMS (2-year 13.3%, overall 12.5%).</div></div><div><h3>Conclusions</h3><div>Hyperautofluorescent ring sensitivity and mFTP showed comparable performance in both trend- and event-based analyses, superior to that of MMS and ESS. Additional advantage of mFTP is inclusion of patients without the autofluorescent ring.</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 2","pages":"Article 101018"},"PeriodicalIF":4.6,"publicationDate":"2025-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145925828","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 : 2025-11-21DOI: 10.1016/j.xops.2025.101016
David L. Zhang MD, Isaac Bakis BS, Russel H. Dinh MD, Megan S. Steinkerchner MD, Avni P. Finn MD, MBA
Objective
To describe and compare characteristics of rhegmatogenous retinal detachments (RRDs) on ultra-widefield (UWF) color fundus photography versus UWF fundus autofluorescence (FAF).
Design
A retrospective observational study.
Participants
Patients presenting with RRDs at 1 tertiary medical center from 2022 to 2025. Patients without UWF color and FAF imaging at initial presentation and those with total retinal detachments or poor image quality were excluded.
Methods
Rhegmatogenous retinal detachments were graded for the following characteristics: clock hours of detachment, quadrants involved, number of breaks, and macular involvement and compared between UWF fundus photography and FAF. Rhegmatogenous retinal detachment duration was determined by patient-reported symptom onset and categorized as acute (<2 weeks) or chronic (>2 weeks). Color photographs were further assessed for bullous appearance. Fundus autofluorescence images were also assessed for the presence of hyperautofluorescent dots and presence of a hyperautofluorescent leading edge of the detachment.
Main Outcome Measures
(1) Differences in detachment grading as assessed by UWF color photography versus autofluorescence and (2) association of hyperautofluorescent dots and leading edge with detachment duration.
Results
Ninety-three eyes of 92 patients with RRDs were included. Ultra-widefield color fundus photography and FAF were equivalent when evaluating clock hours, quadrants involved, and macular or foveal involvement (P > 0.05). Bullous detachments were associated with a corrugated appearance on color photographs (P < 0.001) and were associated with more acute detachments (P = 0.005) and uniform hypoautofluorescence over the area of detachment (P = 0.03). A hyperautofluorescent leading edge was significantly associated with symptom duration <2 weeks (P = 0.01). In contrast, hyperautofluorescent dots on the area of detachment were associated with detachment duration >2 weeks (P < 0.001).
Conclusions
Fundus autofluorescence may be helpful in determining the duration of RRDs and aid in surgical planning. A hyperautofluorescent leading edge on FAF was associated with detachments of shorter duration, while hyperautofluorescent dots were associated with detachments of longer duration. These findings may be useful adjuncts in determining chronicity and be validated in future studies as a biomarker for pathophysiologic changes occurring with increased duration of retinal detachment.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Ultra-Widefield Fundus Autofluorescence Findings as an Indicator of Duration in Rhegmatogenous Retinal Detachment","authors":"David L. Zhang MD, Isaac Bakis BS, Russel H. Dinh MD, Megan S. Steinkerchner MD, Avni P. Finn MD, MBA","doi":"10.1016/j.xops.2025.101016","DOIUrl":"10.1016/j.xops.2025.101016","url":null,"abstract":"<div><h3>Objective</h3><div>To describe and compare characteristics of rhegmatogenous retinal detachments (RRDs) on ultra-widefield (UWF) color fundus photography versus UWF fundus autofluorescence (FAF).</div></div><div><h3>Design</h3><div>A retrospective observational study.</div></div><div><h3>Participants</h3><div>Patients presenting with RRDs at 1 tertiary medical center from 2022 to 2025. Patients without UWF color and FAF imaging at initial presentation and those with total retinal detachments or poor image quality were excluded.</div></div><div><h3>Methods</h3><div>Rhegmatogenous retinal detachments were graded for the following characteristics: clock hours of detachment, quadrants involved, number of breaks, and macular involvement and compared between UWF fundus photography and FAF. Rhegmatogenous retinal detachment duration was determined by patient-reported symptom onset and categorized as acute (<2 weeks) or chronic (>2 weeks). Color photographs were further assessed for bullous appearance. Fundus autofluorescence images were also assessed for the presence of hyperautofluorescent dots and presence of a hyperautofluorescent leading edge of the detachment.</div></div><div><h3>Main Outcome Measures</h3><div>(1) Differences in detachment grading as assessed by UWF color photography versus autofluorescence and (2) association of hyperautofluorescent dots and leading edge with detachment duration.</div></div><div><h3>Results</h3><div>Ninety-three eyes of 92 patients with RRDs were included. Ultra-widefield color fundus photography and FAF were equivalent when evaluating clock hours, quadrants involved, and macular or foveal involvement (<em>P</em> > 0.05). Bullous detachments were associated with a corrugated appearance on color photographs (<em>P</em> < 0.001) and were associated with more acute detachments (<em>P</em> = 0.005) and uniform hypoautofluorescence over the area of detachment (<em>P</em> = 0.03). A hyperautofluorescent leading edge was significantly associated with symptom duration <2 weeks (<em>P</em> = 0.01). In contrast, hyperautofluorescent dots on the area of detachment were associated with detachment duration >2 weeks (<em>P</em> < 0.001).</div></div><div><h3>Conclusions</h3><div>Fundus autofluorescence may be helpful in determining the duration of RRDs and aid in surgical planning. A hyperautofluorescent leading edge on FAF was associated with detachments of shorter duration, while hyperautofluorescent dots were associated with detachments of longer duration. These findings may be useful adjuncts in determining chronicity and be validated in future studies as a biomarker for pathophysiologic changes occurring with increased duration of retinal detachment.</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 2","pages":"Article 101016"},"PeriodicalIF":4.6,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145884518","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 : 2025-11-21DOI: 10.1016/j.xops.2025.101019
{"title":"Corrigendum to “Randomized Study of Intravitreal Autologous CD34+ Stem Cells in Central Retinal Vein Occlusion (Treatment of Retinal vein occlusion Using STem cells [TRUST] Report 1): Safety and Feasibility. Ophthalmol Sci. 2026;6:100905”","authors":"","doi":"10.1016/j.xops.2025.101019","DOIUrl":"10.1016/j.xops.2025.101019","url":null,"abstract":"","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 2","pages":"Article 101019"},"PeriodicalIF":4.6,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145976578","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 : 2025-11-20DOI: 10.1016/j.xops.2025.101015
Xiang-Hua Tang PhD, MD, Zhi-Peng Lai PhD, MD, Sheng-Song Xu PhD, MD, Jin-Yi Xu PhD, MD, Xiao Wang MD, Xing-Yu Lei BMed, Zhou-Yue Li PhD, MD, Xiao Yang PhD, MD
Objective
The underlying mechanism of refractive development—whether it is confined to the local eyeball or involves the central visual pathways—remains controversial. This study aimed to explore the effect of optic nerve crush (ONC) on refractive development and lens-induced myopia (LIM) in mice and its potential mechanism.
Design
Laboratory experimental study.
Subjects
Three-week-old C57BL/6 mice were used in this study. The animals were divided into the following experimental groups: ONC group versus sham surgery (SHAM) group; ONC combined with LIM (ONC-LIM) group versus SHAM combined with LIM (SHAM-LIM) group; LIM followed by ONC group verus LIM group versus plano lens group.
Methods
The refraction and ocular biological parameters were measured. Bulk RNA-sequencing analysis was performed on retinas from the ONC group and the SHAM group. Differential expression analysis between groups was conducted using edgeR. Differentially expressed genes were selected by trend analysis to investigate the expression trends over different refractive conditions after ONC. The Kyoto Encyclopedia of Genes and Genomes enrichment, protein-protein interaction analysis, and gene set enrichment analysis were conducted, and quantitative reverse transcription polymerase chain reaction was applied for validation.
Main Outcome Measures
The axial length (AL).
Results
The results indicated that, after ONC, 50% of the mice showed a myopic shift and 25% showed a hyperopic shift, and the changes in AL were consistent with refraction. The ONC-LIM group failed to develop myopic shift or axial elongation, unlike the SHAM-LIM group, suggesting that optical defocus could not induce a myopic shift in mice after ONC. RNA-sequencing analysis revealed several pathways associated with post-ONC refractive status, including glutamatergic synapse, gonadotropin-releasing hormone signaling, and long-term depression.
Conclusions
Our findings suggest that intact optic nerve is necessary for normal murine emmetropization and for the development of LIM. While local ocular mechanisms remain the established paradigm for refractive regulation, our experimental results indicate the potential involvement of CNS pathways in ocular growth regulation. Further studies are needed to elucidate the precise mechanisms and potential interplay between local and central regulatory systems.
Financial Disclosure(s)
The author has no/the authors have no proprietary or commercial interest in any materials discussed in this article.
{"title":"The Effect of Optic Nerve Crush on Lens-Induced Myopia in Mice","authors":"Xiang-Hua Tang PhD, MD, Zhi-Peng Lai PhD, MD, Sheng-Song Xu PhD, MD, Jin-Yi Xu PhD, MD, Xiao Wang MD, Xing-Yu Lei BMed, Zhou-Yue Li PhD, MD, Xiao Yang PhD, MD","doi":"10.1016/j.xops.2025.101015","DOIUrl":"10.1016/j.xops.2025.101015","url":null,"abstract":"<div><h3>Objective</h3><div>The underlying mechanism of refractive development—whether it is confined to the local eyeball or involves the central visual pathways—remains controversial. This study aimed to explore the effect of optic nerve crush (ONC) on refractive development and lens-induced myopia (LIM) in mice and its potential mechanism.</div></div><div><h3>Design</h3><div>Laboratory experimental study.</div></div><div><h3>Subjects</h3><div>Three-week-old C57BL/6 mice were used in this study. The animals were divided into the following experimental groups: ONC group versus sham surgery (SHAM) group; ONC combined with LIM (ONC-LIM) group versus SHAM combined with LIM (SHAM-LIM) group; LIM followed by ONC group verus LIM group versus plano lens group.</div></div><div><h3>Methods</h3><div>The refraction and ocular biological parameters were measured. Bulk RNA-sequencing analysis was performed on retinas from the ONC group and the SHAM group. Differential expression analysis between groups was conducted using edgeR. Differentially expressed genes were selected by trend analysis to investigate the expression trends over different refractive conditions after ONC. The Kyoto Encyclopedia of Genes and Genomes enrichment, protein-protein interaction analysis, and gene set enrichment analysis were conducted, and quantitative reverse transcription polymerase chain reaction was applied for validation.</div></div><div><h3>Main Outcome Measures</h3><div>The axial length (AL).</div></div><div><h3>Results</h3><div>The results indicated that, after ONC, 50% of the mice showed a myopic shift and 25% showed a hyperopic shift, and the changes in AL were consistent with refraction. The ONC-LIM group failed to develop myopic shift or axial elongation, unlike the SHAM-LIM group, suggesting that optical defocus could not induce a myopic shift in mice after ONC. RNA-sequencing analysis revealed several pathways associated with post-ONC refractive status, including glutamatergic synapse, gonadotropin-releasing hormone signaling, and long-term depression.</div></div><div><h3>Conclusions</h3><div>Our findings suggest that intact optic nerve is necessary for normal murine emmetropization and for the development of LIM. While local ocular mechanisms remain the established paradigm for refractive regulation, our experimental results indicate the potential involvement of CNS pathways in ocular growth regulation. Further studies are needed to elucidate the precise mechanisms and potential interplay between local and central regulatory systems.</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 2","pages":"Article 101015"},"PeriodicalIF":4.6,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145884486","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 : 2025-11-17DOI: 10.1016/j.xops.2025.101013
Lixue Liu MD, PhD , Mingyuan Li MS , Yuxuan Wu MD, PhD , Zizheng Cao MD , Yuanjun Shang MD , Lanqin Zhao MS , Zhenyu Wang MD , Junwei Tan BM , Yan Yuan BM , Wenbin Huang MD, PhD , Jinghui Wang PhD , Jianqiao Li PhD , Fabao Xu PhD , Zhangkai Lian MD , Jianyu Pang MS , Fan Xu PhD , Ningning Tang PhD , Xingru He DrPH, MBA , Yan Xu MD , Kun Zeng MD, PhD , Haotian Lin MD, PhD
<div><h3>Purpose</h3><div>To develop and validate OCT-PRO, a multimodal machine learning model integrating OCT images and clinical traits to predict postoperative visual outcomes in cataract patients.</div></div><div><h3>Design</h3><div>Multicenter prospective cohort study.</div></div><div><h3>Participants</h3><div>A total of 2225 eyes from 1911 cataract patients were enrolled, including 1304 participants from Zhongshan Ophthalmic Center for model development and 607 from 6 hospitals across China for external testing.</div></div><div><h3>Methods</h3><div>All participants underwent standardized preoperative examinations including macular OCT and clinical data collection, followed by phacoemulsification and intraocular lens implantation. Postoperative best-corrected visual acuity (BCVA) was assessed at 4 weeks after surgery. A multimodal model was constructed using deep learning techniques, combining image features extracted via InceptionResNetV2 and structured metadata processed by fully connected layers. Model performance was assessed using mean absolute error (MAE) and root mean square error (RMSE) and compared with traditional laser interferometry and ophthalmologist predictions. Subgroup analysis and explainability assessments were conducted to evaluate generalizability and model attention.</div></div><div><h3>Main Outcome Measures</h3><div>Prediction error of postoperative BCVA (logarithm of the minimum angle of resolution [logMAR]) measured by MAE and RMSE.</div></div><div><h3>Results</h3><div>In the internal test data set, OCT-PRO achieved improved performance, with lower MAE and RMSE (0.128 and 0.211 logMAR) compared with the OCT-only model (0.138 and 0.226 logMAR), metadata-only model (0.161 and 0.234 logMAR) and laser interferometry (0.381 and 0.554 logMAR). In the external test data set, OCT-PRO achieved an MAE of 0.168 logMAR, significantly outperforming the OCT-only (0.183 logMAR, <em>P</em> = 0.003) and metadata-only models (0.229 logMAR, <em>P</em> < 0.001). Subgroup analyses confirmed consistent advantages of OCT-PRO across different cataract subtypes and baseline preoperative BCVA groups. Model interpretability analysis highlighted the importance of preoperative BCVA, age, and macular foveal structure, with greater reliance on OCT features than clinical metadata—especially in complex or low preoperative BCVA cases. In a head-to-head comparison, the model consistently outperformed both junior and senior ophthalmologists in predictive accuracy across various clinical subtypes.</div></div><div><h3>Conclusions</h3><div>OCT-PRO enables accurate prediction of postoperative visual outcomes in cataract surgery, outperforming conventional methods and ophthalmologists. It holds promise as a valuable decision-support tool to assist surgical decision-making and improve health care resource allocation.</div></div><div><h3>Financial Disclosure(s)</h3><div>The author has no/the authors have no proprietary or commercial interest in any materia
目的开发并验证OCT- pro多模态机器学习模型,将OCT图像与临床特征相结合,用于预测白内障患者术后视力结果。设计多中心前瞻性队列研究。共纳入1911例白内障患者的2225只眼,其中1304只来自中山眼科中心进行模型开发,607只来自全国6家医院进行外部测试。方法术前进行黄斑OCT检查及临床资料收集,行超声乳化术及人工晶状体植入术。术后4周评估最佳矫正视力(BCVA)。结合InceptionResNetV2提取的图像特征和全连接层处理的结构化元数据,利用深度学习技术构建了多模态模型。使用平均绝对误差(MAE)和均方根误差(RMSE)评估模型的性能,并与传统激光干涉测量和眼科医生的预测进行比较。通过亚组分析和可解释性评估来评估通用性和模型关注。主要观察指标用MAE和RMSE测量术后BCVA的预测误差(最小分辨角的对数[logMAR])。结果在内部测试数据集中,OCT-PRO比oct -纯模型(0.138和0.226 logMAR)、元数据模型(0.161和0.234 logMAR)和激光干涉测量(0.381和0.554 logMAR)具有更低的MAE和RMSE(0.128和0.211 logMAR)。在外部测试数据集中,OCT-PRO获得了0.168 logMAR的MAE,显著优于OCT-only模型(0.183 logMAR, P = 0.003)和元数据模型(0.229 logMAR, P < 0.001)。亚组分析证实OCT-PRO在不同白内障亚型和基线术前BCVA组中具有一致的优势。模型可解释性分析强调了术前BCVA、年龄和黄斑中央凹结构的重要性,与临床元数据相比,对OCT特征的依赖性更大,尤其是在复杂或术前BCVA较低的病例中。在头对头比较中,该模型在各种临床亚型的预测准确性方面始终优于初级和高级眼科医生。结论soct - pro能准确预测白内障术后视力,优于常规方法和眼科医生。它有望成为一种有价值的决策支持工具,以协助外科决策和改善卫生保健资源分配。财务披露作者在本文中讨论的任何材料中没有/作者没有专有或商业利益。
{"title":"OCT-PRO: A Multimodal Model Integrating OCT and Clinical Traits to Predict Postoperative Outcomes in Cataract Patients","authors":"Lixue Liu MD, PhD , Mingyuan Li MS , Yuxuan Wu MD, PhD , Zizheng Cao MD , Yuanjun Shang MD , Lanqin Zhao MS , Zhenyu Wang MD , Junwei Tan BM , Yan Yuan BM , Wenbin Huang MD, PhD , Jinghui Wang PhD , Jianqiao Li PhD , Fabao Xu PhD , Zhangkai Lian MD , Jianyu Pang MS , Fan Xu PhD , Ningning Tang PhD , Xingru He DrPH, MBA , Yan Xu MD , Kun Zeng MD, PhD , Haotian Lin MD, PhD","doi":"10.1016/j.xops.2025.101013","DOIUrl":"10.1016/j.xops.2025.101013","url":null,"abstract":"<div><h3>Purpose</h3><div>To develop and validate OCT-PRO, a multimodal machine learning model integrating OCT images and clinical traits to predict postoperative visual outcomes in cataract patients.</div></div><div><h3>Design</h3><div>Multicenter prospective cohort study.</div></div><div><h3>Participants</h3><div>A total of 2225 eyes from 1911 cataract patients were enrolled, including 1304 participants from Zhongshan Ophthalmic Center for model development and 607 from 6 hospitals across China for external testing.</div></div><div><h3>Methods</h3><div>All participants underwent standardized preoperative examinations including macular OCT and clinical data collection, followed by phacoemulsification and intraocular lens implantation. Postoperative best-corrected visual acuity (BCVA) was assessed at 4 weeks after surgery. A multimodal model was constructed using deep learning techniques, combining image features extracted via InceptionResNetV2 and structured metadata processed by fully connected layers. Model performance was assessed using mean absolute error (MAE) and root mean square error (RMSE) and compared with traditional laser interferometry and ophthalmologist predictions. Subgroup analysis and explainability assessments were conducted to evaluate generalizability and model attention.</div></div><div><h3>Main Outcome Measures</h3><div>Prediction error of postoperative BCVA (logarithm of the minimum angle of resolution [logMAR]) measured by MAE and RMSE.</div></div><div><h3>Results</h3><div>In the internal test data set, OCT-PRO achieved improved performance, with lower MAE and RMSE (0.128 and 0.211 logMAR) compared with the OCT-only model (0.138 and 0.226 logMAR), metadata-only model (0.161 and 0.234 logMAR) and laser interferometry (0.381 and 0.554 logMAR). In the external test data set, OCT-PRO achieved an MAE of 0.168 logMAR, significantly outperforming the OCT-only (0.183 logMAR, <em>P</em> = 0.003) and metadata-only models (0.229 logMAR, <em>P</em> < 0.001). Subgroup analyses confirmed consistent advantages of OCT-PRO across different cataract subtypes and baseline preoperative BCVA groups. Model interpretability analysis highlighted the importance of preoperative BCVA, age, and macular foveal structure, with greater reliance on OCT features than clinical metadata—especially in complex or low preoperative BCVA cases. In a head-to-head comparison, the model consistently outperformed both junior and senior ophthalmologists in predictive accuracy across various clinical subtypes.</div></div><div><h3>Conclusions</h3><div>OCT-PRO enables accurate prediction of postoperative visual outcomes in cataract surgery, outperforming conventional methods and ophthalmologists. It holds promise as a valuable decision-support tool to assist surgical decision-making and improve health care resource allocation.</div></div><div><h3>Financial Disclosure(s)</h3><div>The author has no/the authors have no proprietary or commercial interest in any materia","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 2","pages":"Article 101013"},"PeriodicalIF":4.6,"publicationDate":"2025-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145798002","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}