AI for the Detection of Retinal Disease and Glaucoma in Patients With Diabetes Mellitus in Primary Care

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 using a nonmydriatic camera has been widely demonstrated to be an effective system to control and prevent the onset of DR. Convolutional neural networks have been used to detect DR, achieving very high sensitivities and specificities.

Hypothesis It is possible to develop algorithms based on artificial intelligence that can demonstrate equal or superior performance and that constitute an alternative to the current screening of RD and other ophthalmic pathologies in diabetic patients.

Objectives:

* Development of an artificial intelligence system for the detection of signs of retinal pathology and other ophthalmic pathologies in diabetic patients.
* Scientific validation of the system to be used as a screening system in primary care.

Methods:

This project will consist of carrying out two studies simultaneously:

1. Development of an algorithm with artificial intelligence to detect signs of DR, other pathologies of the central retina and glaucoma in patients with diabetes.
2. Carrying out a prospective study that will make it possible to compare the diagnostic capacity of the algorithms with that of the family medicine specialists who read the background images. The reference will be double-blind reading by ophthalmologists who specialize in retina.

Cession of the images began at the end of 2018. The development of the AI algorithm is calculated to last about 3 to 4 months. Inclusion of patients in the cohort will start in early 2019 and is expected to last 3 to 4 months. Preliminary results are expected to be published by the end of 2019.

The study will allow the development of an algorithm based on AI that can demonstrate an equal or superior performance, and that constitutes a complement or an alternative, to the current screening of DR in diabetic patients

Conditions

• Diabetic Retinopathy

Interventions

DIAGNOSTIC_TEST

algorithm

The diagnostic capacity of the algorithm will be compared with that of the family medicine physicians and with retina specialists. The reference will be a blinded double reading conducted by the retina specialists

Sponsors & Collaborators

• OPTretina

  collaborator UNKNOWN

• Institut Català de la Salut

  collaborator OTHER

• Department of Health, Generalitat de Catalunya

  collaborator OTHER_GOV

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  lead OTHER

Principal Investigators

• Josep Vidal-Alaball, MD, PhD, MPH · Institut Català de la Salut / IDIAP Jordi Gol

• Alba Arocas Bonache, RN · Institut Català de la Salut

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2022-03-31

Completion

2023-09-26

Countries

• Spain

Study Locations