AI-Assisted vs Conventional Teleglaucoma Referral (GATES)
Artificial Intelligence-Assisted Teleophthalmology for Glaucoma Screening: A Randomized Controlled Trial
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Benjamin Y. Xu, MD, PhD
- Numero di telefono: 323-442-6425
- Email: benjamix@usc.edu
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Provision of signed and dated informed consent
- Age ≥18 years
- Receiving routine teleretinal screening through the Los Angeles County Department of Health Services (LAC DHS) Teleretinal Screening Program
- Positive prediction for referable glaucoma by the validated AI algorithm at the time of screening
- No prior ophthalmology or optometry follow-up within the past year
- Willingness and ability to comply with study procedures and follow-up
Exclusion Criteria:
- Inability to tolerate fundus photography or ungradable fundus images
- Acute vision loss or major ocular complaints requiring immediate in-person evaluation
- Prior glaucoma diagnosis or treatment within the past year
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: AI-Assisted Teleglaucoma Referral
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. |
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. |
|
Comparatore attivo: Conventional Teleglaucoma Referral
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. |
Fundus photographs will undergo conventional manual grading by LAC DHS optometrists, with referral and prioritization performed according to current clinical practice. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to in-office diagnosis of glaucoma
Lasso di tempo: From screening through 36 months
|
Number of days from the initial teleophthalmology screening to the first in-office glaucoma evaluation at which manifest glaucoma is diagnosed. |
From screening through 36 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Visual field mean deviation (MD)
Lasso di tempo: Baseline and 36 months
|
Glaucoma disease severity assessed using visual field mean deviation (MD), measured in decibels (dB), at baseline and 36 months. |
Baseline and 36 months
|
|
Visual field index (VFI)
Lasso di tempo: Baseline and 36 months
|
Glaucoma disease severity assessed using visual field index (VFI), expressed as a percentage (%), at baseline and 36 months. |
Baseline and 36 months
|
|
Mean retinal nerve fiber layer (RNFL) thickness
Lasso di tempo: Time Frame: Baseline and 36 months
|
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: Baseline and 36 months
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- APP-26-03722
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
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