Actively Recruiting
AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening at Primary Health Care Setting: a Pragmatic Trial
Led by The Hong Kong Polytechnic University · Updated on 2025-03-24
500
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an AI-powered low-cost portable fundus camera designed to screen for diabetic retinopathy in primary health care settings. This pragmatic trial aims to assess the success rate of a do-it-yourself (DIY) screening system without active assistant help, along with its accuracy, detection rate, adherence to referral, participant experience, and cost-effectiveness in real-world clinics. Participants will undergo AI-powered fundus camera screening followed by a physician or optometrist consultation. They will complete surveys with questionnaires and participate in a phone interview three months after their baseline assessment. The trial will be conducted over three months in multiple clinics, collecting data from up to 700 patients across different healthcare settings. Throughout the study, researchers will monitor technical feasibility, including image quality and clinic workflow impact, as well as consumer acceptability and satisfaction. Key outcomes include the success rate of the DIY system, diagnostic accuracy, disease detection rates, adherence to referrals, and cost-effectiveness. Participants will be followed up for three months to evaluate these measures and overall experience.
CONDITIONS
Brief Title
AI-Powered DIY Screening System for Diabetic Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes
- Have not undertaken an eye examination in the previous 12 months
- Provide written informed consent
You will not qualify if you...
- Individuals with physical disabilities that prevent the use of a fundus camera
- Individuals with speech impairments who are unable to complete telephone follow-ups
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants undergo AI-powered fundus camera screening and physician/optometrist consultation. They also complete surveys and questionnaires.
1 baseline visit and 1 follow-up phone interview
Trial Site Locations
Total: 1 location
1
SPGC and Optometry Clinics
Hong Kong, Hong Kong
Actively Recruiting
Research Team
M
Mingguang He
Y
Yanxian Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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