An interventional study of AI-Assisted Teleglaucoma Referral Pathway and Conventional Teleglaucoma Referral Pathway in Glaucoma, sponsored by University of Southern California. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Southern California · Not applicable, Interventional, and Diagnostic
This randomized controlled trial will compare an artificial intelligence (AI)-assisted teleglaucoma referral pathway with conventional referral among adults identified with referable glaucoma through the Los Angeles County Department of Health Services (LAC DHS) Teleretinal Screening Program. The primary objective is to determine whether AI-assisted referral reduces time to in-office diagnosis of manifest glaucoma. Secondary outcomes include glaucoma severity, visual function, need for glaucoma surgery, patient-reported quality of life and satisfaction, health system resource utilization, and cost-effectiveness.
Participants identified with referable glaucoma during routine teleretinal screening will be randomized 1:1 to an AI-assisted referral pathway or a conventional referral pathway.
In the AI-assisted arm, fundus photographs will be analyzed using validated deep learning models integrated within the Eye-AI platform. AI outputs, together with intraocular pressure and other clinical information, will be used to stratify referral urgency. AI-generated recommendations will undergo review by glaucoma specialists before referral.
In the conventional referral arm, fundus images will undergo manual review by LAC DHS optometrists, with referral and prioritization performed according to current clinical practice.
Participants in both groups will undergo comprehensive in-office glaucoma evaluation following referral and will be followed for up to 36 months. The primary outcome is time from screening to in-office diagnosis of manifest glaucoma. Secondary outcomes will evaluate disease severity and visual function, need for glaucoma surgery, patient-reported quality of life and satisfaction, health system resource utilization, and cost-effectiveness.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 1,386 is above the median of 61 across 964 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo AI-assisted referral using validated deep learning models integrated within the Eye-AI platform. AI outputs, together with intraocular pressure and other clinical information, will be used to stratify referral urgency. AI-generated recommendations will be reviewed by glaucoma specialists before referral.
Other: AI-Assisted Teleglaucoma Referral Pathway
Participants will undergo conventional teleglaucoma referral based on manual grading of fundus photographs by LAC DHS optometrists, with referral and prioritization performed according to current clinical practice.
Other: Conventional Teleglaucoma Referral Pathway
Fundus photographs acquired during routine teleretinal screening will be analyzed using validated deep learning models integrated within the Eye-AI platform. For participants identified with referable glaucoma, AI outputs will be combined with intraocular pressure and other clinical information to stratify referral urgency. All AI-generated recommendations will undergo review by a glaucoma specialist before referral.
Fundus photographs will undergo conventional manual grading by LAC DHS optometrists, with referral and prioritization performed according to current clinical practice.
Time to in-office diagnosis of glaucoma
Number of days from the initial teleophthalmology screening to the first in-office glaucoma evaluation at which manifest glaucoma is diagnosed.
Time frame: From screening through 36 months
Visual field mean deviation (MD)
Glaucoma disease severity assessed using visual field mean deviation (MD), measured in decibels (dB), at baseline and 36 months.
Time frame: Baseline and 36 months
Visual field index (VFI)
Glaucoma disease severity assessed using visual field index (VFI), expressed as a percentage (%), at baseline and 36 months.
Time frame: Baseline and 36 months
Mean retinal nerve fiber layer (RNFL) thickness
Glaucoma disease severity assessed using mean retinal nerve fiber layer (RNFL) thickness measured by optical coherence tomography (OCT), expressed in micrometers (µm), at baseline and 36 months.
Time frame: Time Frame: Baseline and 36 months
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared because patient-level health data from the Los Angeles County Department of Health Services (LAC DHS) are subject to HIPAA and LAC DHS data-sharing restrictions. Aggregate-level study results and derived analytic outputs will be shared in accordance with NIH policy and the approved Data Management and Sharing Plan.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2032, 71 months later.
Of 229 non-industry interventional studies with no phase under Glaucoma, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's planned 71 months is above that.
Counting every sponsor, half of 287 studies reached it within 30 months; a quarter within 12 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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