Status:
COMPLETED
Bangladesh PRODUCTIVity in Eyecare Trial
Lead Sponsor:
Orbis
Collaborating Sponsors:
Digital Diagnostics, Inc.
Deep Eye Care Foundation (DECF)
Conditions:
Diabetic Retinopathy
Diabetic Macular Edema
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 ...
Detailed Description
Bangladesh PRODUCTIVity in Eyecare (B-PRODUCTIVE) Trial Study Aim: To assess the impact of using autonomous artificial intelligence (AI) for identification of diabetic retinopathy (DR) and diabetic m...
Eligibility Criteria
Inclusion
- Retina specialists regularly seeing patients with DR
- Routinely examines \>= 20 patients with diabetes without known diabetic retinopathy or diabetic macular edema per week
- Routinely provides laser treatment or intravitreal injections to \>= 3 DR patients/month
- Patients
- Diagnosed with type 1 or 2 diabetes
- Presenting visual acuity \>= 6/18 best corrected visual acuity in the better-seeing eye
Exclusion
- Retina specialists
- Currently using an AI system integrated into their clinical care and/or inability to provide informed consent.
- Patients
- Inability to provide informed consent or understand the study; persistent vision loss, blurred vision or floaters; previously diagnosed with diabetic retinopathy or diabetic macular edema; history of laser treatment of the retina or injections into either eye, or any history of retinal surgery; contraindicated for imaging by fundus imaging systems
Key Trial Info
Start Date :
March 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
993 Patients enrolled
Trial Details
Trial ID
NCT05182580
Start Date
March 20 2022
End Date
July 31 2022
Last Update
February 6 2024
Active Locations (1)
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1
Deep Eye Care Foundation
Rangpur City, Bangladesh