GlaukomAI: Clinical Validation of an AI System for Early Glaucoma Screening
Starting soon · Not applicable
Conditions studied: Glaucoma
In brief
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.
Key facts
- Study ID
- NCT07668193
- Run by
- Fondazione G.B. Bietti, IRCCS
- People needed
- 1200
- Starts
- 2026-06-01
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.