CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 993 enrolled
Drug / intervention
Results utilized from autonomous AI diagnostic system for diabetic retinopathy and/or diabetic macular edemaother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05182580
NCT05182580N/ACompleted

Assessing the Impact of Using Autonomous Artificial Intelligence (AI) for Pre-screening of Diabetic Retinopathy (DR) and Diabetic Macular Edema on Physician Productivity in Bangladesh

Orbis·interventional·Posted Jan 10, 2022·Updated Feb 6, 2024

In Brief

A clinical study evaluating Results utilized from autonomous AI diagnostic system for diabetic retinopathy and/or diabetic macular edema for Diabetic Retinopathy and Diabetic Macular Edema. Completed, enrolled 993 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the impact of using autonomous artificial intelligence (AI) system for identification of diabetic retinopathy (DR) and diabetic macular edema on productivity of retina specialists in Bangladesh. Globally, the number of people with diabetes mellitus is increasing. Diabetic retinopathy is a chronic, progressive complication of diabetes mellitus that affects the microvasculature of the retina, which if left untreated can potentially result in vision loss. Early detection and treatment of diabetic retinopathy can prevent potential blindness. Study Aim: To assess the impact of using autonomous artificial intelligence (AI) system for detection of diabetic retinopathy (DR) and diabetic macular edema on physician productivity in Bangladesh. Main study question: Will ophthalmologists with clinic days randomized to use autonomous AI DR detection for all persons with diabetes (diagnosed or un-diagnosed) visiting their clinic system have a greater number of examined patients with diabetes (by either AI or clinical exam), and a greater complexity of examined patients on a recognized grading scale, per physician working hour than those randomized not to have autonomous AI screening for their diabetes population? The investigators anticipate that this study will demonstrate an increase in physician productivity, supporting efficiency for both physicians and patients, while also addressing increased access for DR screening; ultimately, preventing vision loss amongst diabetic patients. The study has the potential to contribute to the evidence base on the benefits of AI for physicians and patients. Additionally, the study has the potential to demonstrate the benefits (and/or challenges) of implementing AI in resource-constrained settings, such as Bangladesh.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBangladesh

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 10, 2022
Enrollment StartMar 20, 2022
Primary CompletionJul 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.5 years ago

Interventions

Results utilized from autonomous AI diagnostic system for diabetic retinopathy and/or diabetic macular edemaother

If patients receive a negative result they do not see the retina specialist