Artificial Intelligence-assisted Diagnosis in Ophthalmology

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.

NCT Number	NCT07497815
Lead Sponsor	Marisse Masis-Solano Collaborators: Iriscience Inc
Conditions	Macular Degeneration, Diabetic Retinopathy (DR), Glaucoma, Keratoconus, Cataract
Enrollment	15,000 participants
Start Date	2026-05-01
Primary Completion	2028-05-01 (estimated)
Study Completion	2029-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-01