ArticleOphthalmology science
Pivotal Trial Toward Effectiveness of Self-administered OCT in Neovascular Age-related Macular Degeneration. Report 2-Artificial Intelligence Analytics.
Article in Ophthalmology science. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed.
- Artificial intelligence in ophthalmology: From diagnostic accuracy to clinical application.World journal of methodology · 2026Review
- Evaluating Time in Range for Visual Acuity and Macular Thickness as Outcome Measures for Randomized Clinical Trials.Translational vision science & technology · 2026Article
- Home OCT Monitoring as a Safety Net for Early Detection of Recurrent Disease Activity in Neovascular Age-Related Macular Degeneration Under Standard Care.Medicina (Kaunas, Lithuania) · 2026Article
- Longitudinal Validation of the Artificial Intelligence Algorithm in Home OCT for Age-Related Macular Degeneration-Report 3.Ophthalmology science · 2026Article
- Expanding Access to Retinal Imaging Through Patient-Operated Optical Coherence Tomography in a Veterans Affairs Retina Clinic.Bioengineering (Basel, Switzerland) · 2026Article
- Compact vision language models enable efficient and interpretable optical coherence tomography through layer-specific multimodal learning.Communications medicine · 2025Article
- Home Monitoring for the Management of Age-Related Macular Degeneration: A Review of the Development and Implementation of Digital Health Solutions over a 25-Year Scientific Journey.Medicina (Kaunas, Lithuania) · 2025Review
- Optimizing Early Ophthalmology Clinical Trials: Home OCT and Modeling Can Reduce Sample Size by 20% to 40.Translational vision science & technology · 2025Article
- Retinal Thickness Analysis Using Optical Coherence Tomography: Diagnostic and Monitoring Applications in Retinal Diseases.Diagnostics (Basel, Switzerland) · 2025Review
- A Novel Foundation Model-Based Framework for Multimodal Retinal Age Prediction.IEEE journal of translational engineering in health and medicine · 2025Article
- Pivotal Trial Validating Usability and Visualization Performance of Home OCT in Neovascular Age-Related Macular Degeneration: Report 1.Ophthalmology scienceArticle
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: To validate the performance of the Notal OCT Analyzer (NOA) in processing self-administered OCT images from an OCT system designed for home use (home OCT [HOCT]) as part of a pivotal study aimed at achieving de novo United States Food and Drug Admininstration marketing authorization. Design: A prospective quantitative cross-sectional artificial intelligence study. Participants: The study enrolled adults aged ≥55 years diagnosed with neovascular age-related macular degeneration (nAMD) in ≥1 eligible eye with a best-corrected visual acuity of 20/320 or better. Methods: Participants self-imaged 4 times on each of 2 HOCT devices and once with an in-office OCT (IO-OCT) device during a single visit. Scans were segmented by the NOA and human graders at a certified reading center (RC). Main Outcome Measures: Intradevice and interdevice repeatability and reproducibility of total retinal hyporeflective (TRO) volume estimation by the NOA on HOCT-acquired images as compared with that of RC graders on IO-OCT-acquired images. Additionally, to assess the performance of the NOA in segmentation of TRO over multiple B-scans as compared with RC graders. Results: Self-imaging was performed successfully by 387 participants in 2451 of 2616 attempts (93.7%). For repeatability, the coefficient of variance for NOA was 11.1% for eyes with >10 volume units of TRO imaged with HOCT compared with 16.4% for RC graders segmenting IO-OCT images. The median DICE similarity coefficients for segmentation of TRO by NOA vs. Grader 1, Grader 2, and Grader 3; Grader 1 vs. Grader 2 and Grader 3; and Grader 2 vs. Grader 3 were 0.68, 0.68, 0.61, 0.72, 0.63, 0.70, respectively. Conclusions: The performance of NOA supports the intended use of the system as a tool to monitor TRO at home between routine clinical visits in support of the management of nAMD. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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