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The efficacy and cost-effectiveness of a deep-learning system for supporting diabetic macular edema triage screening: a randomised controlled trial

The efficacy and cost-effectiveness of a deep-learning system for supporting diabetic macular edema triage screening: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075087
Enrollment
Unknown
Registered
2023-08-24
Start date
2023-09-01
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Diabetic macular edema

Interventions

Intervention group:OCT examination, visual acuity examination, ultra-widefield scanning laser ophthalmoscopy, collection of baseline demographics and systemic medical history
DME assessed with additional help from the AI-OCT system.
Control group:OCT examination, visual acuity examination, ultra-widefield scanning laser ophthalmoscopy, collection of baseline demographics and systemic medical history
DME will be assessed based on standard routine only.

Sponsors

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Individuals with DM and aged over 18; 2. Individuals with FP reports showing suspected DME (i.e., presence of diabetic maculopathy, DME or exudate around the macula, mentioned in the FP report).

Exclusion criteria

Exclusion criteria: 1. Individuals with other ocular diseases that are sight-threatening and require urgent treatment, such as wet age-related macular degeneration, proliferative DR, retinal detachment, vitreo-macular traction, foveoschisis, retinal vein occlusion, retinal artery occlusion. 2. Individuals who refuse or are unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
The efficacy of the AI-OCT system, including false-positive DME referral rate and the true-positive DME referral rate;

Secondary

MeasureTime frame
Results of the cost-effectiveness analysis;

Countries

China

Contacts

Public ContactDr Cheung Yim Lui Carol

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

carolcheung@cuhk.edu.hk+852 3943 5831

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 17, 2026