Artificial Intelligence-assisted Diagnosis in Ophthalmology
Starting soon
Conditions studied: Macular Degeneration, Diabetic Retinopathy (DR), Glaucoma, Keratoconus, Cataract
In brief
This is a retrospective, multicenter, observational study designed to develop and validate an artificial intelligence (AI) system capable of detecting and classifying major ophthalmic diseases (glaucoma, cataract, diabetic retinopathy, and other retinal pathologies) in the Costa Rican population. The study will use approximately 15,000 existing medical images from digital archives of two ophthalmic centers in Costa Rica, without active participant recruitment or capture of new images. The primary motivation is that AI systems developed in other countries (primarily Asian, European, or North American populations) do not necessarily perform with the same accuracy when applied to Latin American populations. This study seeks to establish a precedent for the importance of locally validating any medical AI technology before clinical implementation.
Key facts
- Study ID
- NCT07497815
- Run by
- Marisse Masis-Solano
- People needed
- 15000
- Starts
- 2026-05-01
- Expected to finish
- 2029-05-01
- Last updated by the study team
- 2026-04-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Image corresponds to patient ≥18 years of age at time of capture
- Image modality is one of: fundus photography, posterior segment OCT, anterior segment photography, automated perimetry, or video-OCT
- Image quality sufficient for diagnostic interpretation (adequate resolution, focus, illumination, complete visualization of anatomical area of interest, no major artifacts)
- Minimum clinical data available (age or age group, sex, and diagnosis or clinical indication)
- Image captured during routine clinical care (not specifically for research)
- No patient objection to use of medical data for research (when applicable per center policy)
You may not qualify if…
- CLINICAL:
- Images from eyes with recent intraocular surgery (<3 months)
- Images from eyes with severe ocular trauma distorting anatomy
- Images from patients with rare or unique ocular pathologies not allowing generalization
- Images post-recent laser treatment where acute changes may confuse analysis
- TECHNICAL:
- Severely degraded image quality (extreme blur, severe under/overexposure, major artifacts preventing interpretation)
- Duplicate images of same eye on same date
- Images with missing or clearly erroneous metadata
- Images in non-standard or corrupted formats that cannot be processed
- Sex/Gender: All Minimum Age: 18 Years Maximum Age: No limit Accepts Healthy Volunteers: Yes (images of healthy eyes without pathology are included as controls)
Where it is running
- Centro Ocular — Heredia, Centro, Costa Rica
- Asociados de Mácula y Vítreo de Costa Rica — San José, Provincia de San José, Costa Rica
Full record on ClinicalTrials.gov
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