🏛️ Verified NIH Record • Updated 2026-03-26

Artificial Intelligence-assisted Diagnosis in Ophthalmology (NCT07497815)

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

🟡 Not Yet Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Marisse Masis-Solano

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Centro Ocular — Heredia, Centro

Age range: 18 Years

🧪 Interventions in This Study

  • No interventions (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (2 Sites)

  • Centro Ocular — Heredia, Centro
  • Asociados de Mácula y Vítreo de Costa Rica — San José, Provincia de San José

📞 Contact the Study Coordinator

Phone: (929) 327-8463

Email: marisse@irisciencetech.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗