AI-Powered DIY Screening System for Diabetic Retinopathy

NCT06892353 | Recruiting DMC

• 1 other identifier: HSEARS20231218003
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathy; AI; screening system

Outcome Measures

Primary Outcomes (1)

• Success Rate without Active Assistant Help

  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.

  3 months

Secondary Outcomes (16)

• Assessment of Consumer Acceptability

  3 months

• Diagnostic Accuracy

  3 months

• Disease Detection Rates

  3 months

• Adherence to Referral

  3 months

• Technical Feasibility: Quality of Image Acquisition

  3 months

Study Arms (1)

Screening

EXPERIMENTAL

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.

Diagnostic Test: AI-powered fundus camera screening

Interventions

AI-powered fundus camera screening DIAGNOSTIC_TEST

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.

Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

SPGC and Optometry Clinics

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Mingguang He

CONTACT

85234002795; mingguang.he@polyu.edu.hk

Yanxian Chen

CONTACT

85227666111; yan-xian.chen@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: March 24, 2025
• Study Start: March 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)