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

Artificial intelligence-supported diabetic retinopathy screening in Tanzania: A randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18317152

Enrollment

2364

Registered

2023-03-02

Start date

2023-03-08

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic retinopathy Eye Diseases

Interventions

Participants will be randomised to either the artificial intelligence-supported diabetic retinopathy screening pathway with an immediate referral decision and point-of-screening counselling or the sta

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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Secondary

Measure	Time frame
1. The proportion of persons that attend the central ophthalmology clinic within 8 weeks of screening out of all those referred, by trial arm (eye hospital administrative records and reference standard gradings) 2. Sensitivity and specificity for grading any diabetic retinopathy and referable diabetic retinopathy (comparison of AI retinal image gradings against the reference standard retinal image gradings after recruitment completed) 3. Number of false positive cases attending the central ophthalmology clinic, by trial arm (eye hospital administrative records and reference standard retinal image gradings within 8 weeks of screening) 4. Number of patients receiving their first treatment for diabetic retinopathy treatment after referral, by trial arm (reviewing patient notes) 5. Number of gradable versus ungradable retinal images (reference standard retinal image gradings) 6. Time to presentation at hospital (eye hospital administrative records) 7. Incremental cost per quality-adjusted life year (QALY) gained (using a Markov model) 8. Acceptability, appropriateness and fidelity of AI screening (semi-structured interviews with relevant stakeholders and spot checks of intervention delivery throughout the trial)	—

Measure

Time frame

1. The proportion of persons that attend the central ophthalmology clinic within 8 weeks of screening out of all those referred, by trial arm (eye hospital administrative records and reference standard gradings) 2. Sensitivity and specificity for grading any diabetic retinopathy and referable diabetic retinopathy (comparison of AI retinal image gradings against the reference standard retinal image gradings after recruitment completed) 3. Number of false positive cases attending the central ophthalmology clinic, by trial arm (eye hospital administrative records and reference standard retinal image gradings within 8 weeks of screening) 4. Number of patients receiving their first treatment for diabetic retinopathy treatment after referral, by trial arm (reviewing patient notes) 5. Number of gradable versus ungradable retinal images (reference standard retinal image gradings) 6. Time to presentation at hospital (eye hospital administrative records) 7. Incremental cost per quality-adjusted life year (QALY) gained (using a Markov model) 8. Acceptability, appropriateness and fidelity of AI screening (semi-structured interviews with relevant stakeholders and spot checks of intervention delivery throughout the trial)

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Countries

Tanzania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026