AI-Powered DIY Screening System for Diabetic Retinopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-powered fundus camera screening.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Success Rate without Active Assistant Help [Time frame: 3 months]
Secondary outcome measures (12)
- Assessment of Consumer Acceptability [Time frame: 3 months]
- Diagnostic Accuracy [Time frame: 3 months]
- Disease Detection Rates [Time frame: 3 months]
- Adherence to Referral [Time frame: 3 months]
- Technical Feasibility: Quality of Image Acquisition [Time frame: 3 months]
- Cost-effectiveness of DIY Screening [Time frame: 3 months]
- Assessment of Consumer Satisfaction [Time frame: 3 months]
- Diagnostic Accuracy [Time frame: 3 months]
- Diagnostic Accuracy [Time frame: 3 months]
- Diagnostic Accuracy [Time frame: 3 months]
- Diagnostic Accuracy [Time frame: 3 months]
- Technical Feasibility:The duration of Clinic Flow [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Hong Kong · 1 center
- SPGC and Optometry Clinics — Hong Kong
Identifiers
NCT: NCT06892353 · HSEARS20231218003