Artificial intelligence-supported diabetic retinopathy (a complication of diabetes, caused by high blood sugar levels damaging the back of the eye) screening in Tanzania

Not Applicable

• Conditions: Diabetic retinopathy; Eye Diseases

• Registration Number: ISRCTN18317152
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38272554/ (added 30/01/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-02
• Last Update Posted: 15 April 2024
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2364

Inclusion Criteria

Current inclusion criteria as of 11/01/2024:

1. Adult (18 years and older) diabetic patients attending diabetes clinics in Kilimanjaro or Arusha regions.
2. Willing and able to give consent.
3. Agree to be randomised to either AI-supported or standard of care diabetic retinopathy screening

_____

Previous inclusion criteria:

1. Adult (18 years and older) diabetic patients attending diabetes clinics in Kilimanjaro region.
2. Willing and able to give consent.
3. Agree to be randomised to either AI-supported or standard of care diabetic retinopathy screening

Exclusion Criteria

Current exclusion criteria as of 11/01/2024:

1. Unable or unwilling to give consent
2. Less than 18 years old
3. Already attending the central ophthalmology clinic or had a diabetic eye exam in the previous 12 months

_____

Previous exclusion criteria:

1. Unable or unwilling to give consent
2. Less than 18 years old

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of true referable diabetic retinopathy cases attending the central ophthalmology clinic within 8 weeks of screening out of all those with true referable diabetic retinopathy, by trial arm. All retinal images will be graded by UK certified graders to provide the reference standard. It will be these gradings that will determine which participants have true referable diabetic retinopathy in each trial arm and this figure will be the denominator in our primary outcome analysis.<br><br>Follow-up data will be collected from hospital administrative records at the referral eye hospital (Kilimanjaro Christian Medical Centre). The hospital has an electronic patient record system.