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NOT YET RECRUITING
NCT07497815

Artificial Intelligence-assisted Diagnosis in Ophthalmology

Sponsor: Marisse Masis-Solano

View on ClinicalTrials.gov

Summary

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.

Official title: Development and Validation of an Artificial Intelligence-assisted Diagnostic System for Ophthalmic Pathologies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

15000

Start Date

2026-05-01

Completion Date

2029-05-01

Last Updated

2026-04-01

Healthy Volunteers

Yes

Interventions

OTHER

No interventions

This retrospective observational study involves no therapeutic interventions, no treatment modifications, no patient contact, and no comparison groups. It is purely diagnostic technology development and validation using existing historical data.

Locations (2)

Centro Ocular

Heredia, Centro, Costa Rica

Asociados de Mácula y Vítreo de Costa Rica

San José, Provincia de San José, Costa Rica