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Glaucoma Screening With Artificial Intelligence

NCT06012058 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3175

Last updated 2023-09-21

No results posted yet for this study

Summary

This randomized clinical trial aims to compare the diagnostic performance of two AI-enabled screening strategies - ROTA (RNFL optical texture analysis) assessment versus optic disc photography - in detecting glaucoma within a population-based sample. Secondary objectives are to (1) compare the diagnostic performance of ROTA AI assessment versus OCT RNFL thickness assessment by AI, and ROTA AI assessment versus OCT RNFL thickness assessment by trained graders, (2) investigate the cost-effectiveness of AI ROTA assessment for glaucoma screening, and (3) estimate the prevalence of glaucoma in Hong Kong.

Conditions

Interventions

DIAGNOSTIC_TEST

ROTA assessment by AI

The RNFL is imaged with OCT for ROTA and the data are analyzed with a deep learning model.

DIAGNOSTIC_TEST

Optic disc assessment by AI

The optic disc is imaged with color fundus camera and the data are analyzed with a deep learning model.

Sponsors & Collaborators

  • Orbis

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Christopher Leung · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-26
Primary Completion
2024-08-25
Completion
2025-02-25

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06012058 on ClinicalTrials.gov