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A Randomized Controlled Trial of Artificial Intelligence Based Glaucomatous Optic Neuropathy Detection from Optical Coherence Tomography

A Randomized Controlled Trial of Artificial Intelligence Based Glaucomatous Optic Neuropathy Detection from Optical Coherence Tomography

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067259
Enrollment
Unknown
Registered
2023-01-01
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucomatous optic neuropathy (GON)

Interventions

Fully automated AI group:Retinal imaging using OCT and AI-based image analysis
Semi-automated AI group:Clinicians will review the OCT images and printed-out AI reports for subjects
Control group:Retinal imaging using OCT and AI-based image analysis

Sponsors

Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong; Research Office, Health Bureau
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects aged above 18 years; 2. Subjects referred by primary care settings due to glaucoma-related suspicious findings, such as increased cup-to-disc ratio, high intraocular pressure, and disc haemorrhage; 3. Subjects referred by primary care settings for regular eye check-ups; 4. Subjects with a family history of glaucoma; 5. Subjects with diabetes mellitus.

Exclusion criteria

Exclusion criteria: Subjects have already confirmed diagnosis of glaucoma by ophthalmologists.

Design outcomes

Primary

MeasureTime frame
Area under receiver operating characteristic curve (AUROC) value;Sensitivity, specificity, accuracy;Positive predictive value and negative predictive value;

Secondary

MeasureTime frame
The average time of imaging and generating reports in each arm;The average time of clinicians' interpretation in each arm;Misclassification analysis including reasons and corresponding numbers;Clinicians' acceptance of AI-platform assistance and a fully automated AI-platform;Safety outcomes;

Countries

China

Contacts

Public ContactDr RAN Anran Emma

Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong

anranran@cuhk.edu.hk+852 3943 5836

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026