NCT07668193Not yet recruiting
GlaukomAI: Clinical Validation of an AI System for Early Glaucoma Screening
GlaukomAI: Clinical Validation of an Artificial Intelligence-Based System for Early Glaucoma Screening and Diagnosis - A Case-Control Study and Referral Accuracy Assessment
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1200 (estimated)
- First submitted
- 19 Jun 2026
- Start date
- Oct 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Diseases
- Glaucoma
- NCT number
- NCT07668193
What you commit to
- Study type: Interventional
- Planned participants: 1200
- From Oct 2026 to the primary completion date, Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having undergone any ocular surgery in the past 3 months
Other illness
- Presence of media opacities preventing the acquisition of adequate quality fundus imaging (e.g., advanced cataract, vitreous hemorrhage, severe corneal opacities)
Other
- 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)
- Inability to cooperate with perimetric examination
Who the study is looking for
- 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
- Patients affected by any type of glaucoma (primary open-angle, primary angle-closure, secondary glaucoma) on pharmacological therapy
- Absence of ocular pathologies
- IOP \<21 mmHg
- Visual field and OCT within normal limits
- Optic disc of normal appearance on clinical evaluation
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.