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Artificial Intelligence-assisted Diagnosis in Ophthalmology

NCT07497815 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 15000

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Macular Degeneration
  • Diabetic Retinopathy (DR)
  • Glaucoma
  • Keratoconus
  • Cataract

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.

Sponsors & Collaborators

  • Iriscience Inc

    collaborator INDUSTRY

  • Marisse Masis-Solano

    lead INDUSTRY

Principal Investigators

  • Marisse Masis-Solano · Iriscience Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-05-01
Completion
2029-05-01

Countries

  • Costa Rica

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07497815 on ClinicalTrials.gov