NCT06892353

AI-Powered DIY Screening System for Diabetic Retinopathy

AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A pragmatic trial will be conducted in two representative clinics in each of the three types of targeted settings. It will be run for 3 months in each clinic to complete data collection of up to 100 patients in SPGC and Optometry Clinics, 200 at GPGC and 200 in GOPC in total. All the subjects will conduct a DIY screening, physician consultation, survey with questionnaires and a phone interview three months after their baseline assessment. This study will assess automated screening in terms of success rate of the DIY system without active assistant help, accuracy, screening rate and detection rate, adherence to referral and experience of participants, as well as cost-effectiveness in real-world settings.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AI-powered fundus camera screening	All the participants will undertake an AI-powered fundus camera screening, physician/optometrist consultation, survey with questionnaires and a phone interview three months after their baseline assessment.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-06-30
• Completion: 2025-07-31
• First posted: 2025-03-24
• Last updated: 2025-03-24

Locations

1 site across 1 country: Hong Kong