GlaukomAI: Clinical Validation of an AI System for Early Glaucoma Screening (NCT07668193) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
GlaukomAI: Clinical Validation of an AI System for Early Glaucoma Screening
1,200 participantsStarted 2026-06
Plain-language summary
Glaucoma is one of the leading causes of irreversible blindness worldwide. Early diagnosis is crucial to prevent vision loss, but current diagnostic pathways require multiple specialist visits and tests, leading to long waiting times and delayed diagnosis.
This study aims to evaluate the accuracy of GlaukomAI, an artificial intelligence (AI)-based software that analyzes fundus photographs of the eye to detect glaucoma at an early stage.
The study is conducted at IRCCS Fondazione G. B. Bietti (Rome, Italy) and is structured in two phases:
* Phase 1 enrolls 200 participants (100 with diagnosed glaucoma and 100 healthy controls) to assess how accurately GlaukomAI can distinguish between glaucoma and healthy eyes, compared to the judgment of a panel of three expert glaucoma specialists.
* Phase 2 enrolls 1,000 consecutive outpatients to evaluate whether GlaukomAI can correctly identify patients who need referral to a glaucoma specialist, and to compare its performance with that of non-specialist ophthalmologists.
Participants undergo a single study visit including standard ophthalmic examinations (visual acuity, eye pressure measurement, visual field test, OCT, and fundus photography). No investigational drugs or invasive procedures are involved.
The results of this study will provide evidence to support the integration of AI-based tools into routine glaucoma screening pathways, with the goal of reducing diagnostic delays and improving access to care.
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 for all patients:
* Age \>18 years
* Freely given informed consent obtained prior to study initiation
* The participant has the capacity to understand and the willingness to follow study instructions and is likely to complete all required visits and procedures
Inclusion Criteria for glaucoma patients:
Patients affected by any type of glaucoma (primary open-angle, primary angle-closure, secondary glaucoma) on pharmacological therapy
Inclusion Criteria for healthy controls:
* Absence of ocular pathologies
* IOP \<21 mmHg
* Visual field and OCT within normal limits
* Optic disc of normal appearance on clinical evaluation
Exclusion Criteria:
* Presence of media opacities preventing the acquisition of adequate quality fundus imaging (e.g., advanced cataract, vitreous hemorrhage, severe corneal opacities)
* Retinal or optic nerve pathologies that could confound the diagnosis (e.g., non-glaucomatous optic neuropathies (ischemic, inflammatory, compressive), moderate-to-severe diabetic retinopathy, advanced macular degeneration, retinal vascular occlusions)
* Having undergone any ocular surgery in the past 3 months
* Inability to cooperate with perimetric examination
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.
What they're measuring
1
Diagnostic Accuracy of GlaukomAI - Sensitivity and Specificity
Timeframe: At enrollment visit (single visit, or two consecutive visits within 1 week)