AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Success Rate without Active Assistant Help
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes, and
- •have not undertaken an eye examination in the previous 12 months (elevated risk of undiagnosed disease).
- •Provide written informed consent.
Exclusion Criteria
- •individuals with physical disabilities that prevent the use of a fundus camera, or
- •individuals with speech impairments who are unable to complete telephone follow-ups.
Arms & Interventions
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.
Intervention: AI-powered fundus camera screening (Diagnostic Test)
Outcomes
Primary Outcomes
Success Rate without Active Assistant Help
Time Frame: 3 months
Success rate of using the DIY screening booth help will be determined by the number of successful screening runs without active assistant help divided by the total number of screening runs.
Secondary Outcomes
- Assessment of Consumer Acceptability(3 months)
- Technical Feasibility: The type of technical error(3 months)
- Diagnostic Accuracy(3 months)
- Disease Detection Rates(3 months)
- Adherence to Referral(3 months)
- Technical Feasibility: Quality of Image Acquisition(3 months)
- Cost-effectiveness of DIY Screening(3 months)
- Assessment of Consumer Satisfaction(3 months)
- Technical Feasibility:The duration of Clinic Flow(3 months)
- Technical Feasibility:Reporting and Impact on Clinic Flow(3 months)
- Technical Feasibility: Number of Recorded Technical Errors(3 months)
- Technical Feasibility: Remedies for technical errors(3 months)