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NCT06892353 | RECRUITING | Diabetic Retinopathy


AI-Powered DIY Screening System for Diabetic Retinopathy
Sponsor:

The Hong Kong Polytechnic University

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.

Condition or disease

Diabetic Retinopathy

Intervention/treatment

AI-powered fundus camera screening

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 500 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial
Actual Study Start Date : 2025-03-01
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes, and
  • 2. have not undertaken an eye examination in the previous 12 months (elevated risk of undiagnosed disease).
  • 3. Provide written informed consent.
Exclusion Criteria
  • 1. individuals with physical disabilities that prevent the use of a fundus camera, or
  • 2. individuals with speech impairments who are unable to complete telephone follow-ups.

AI-Powered DIY Screening System for Diabetic Retinopathy

Location Details

NCT06892353


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

Hong Kong,

SPGC and Optometry Clinics

Hong Kong, Hong Kong,

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