Status:
COMPLETED
AI for the Detection of Retinal Disease and Glaucoma in Patients With Diabetes Mellitus in Primary Care
Lead Sponsor:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborating Sponsors:
OPTretina
Institut Català de la Salut
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
Phase:
NA
Brief Summary
Background: Diabetic retinopathy (DR) is one of the most important causes of blindness worldwide, especially in developed countries. In diabetic patients, periodic examination of the back of the eye u...
Detailed Description
Study Design This project will follow a methodology consisting of 2 concomitant studies: In the first study, we will develop an AI algorithm to detect the signs of DR in patients with diabetes. The s...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type I or type II diabetes mellitus
- Fundus photograph taken as part of the screening for diabetic retinopathy
Exclusion
- patients with glaucoma under treatment
- patients with advanced dementia who do not collaborate in taking photographs
- patients with significant deafness who cannot follow the instructions for taking photographs
- patients with mobility problems (wheelchairs, important kyphosis) or tremor who cannot take photographs
- patients with pathologies that interfere with the quality of images such as cataracts, nystagmus, corneal leucoma or corneal transplants.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2023
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04132401
Start Date
May 1 2021
End Date
September 26 2023
Last Update
November 25 2025
Active Locations (1)
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1
CAP Bages
Manresa, Barcelona, Spain, 08242