Artificial Intelligence-assisted Diagnosis in Ophthalmology (NCT07497815) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Artificial Intelligence-assisted Diagnosis in Ophthalmology
Costa Rica15,000 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.