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

September 27, 2023 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Artificial Intelligence for the Detection of Central Retinal Disease and Non-mydriatic Glaucoma in the Context of Patients With Diabetes Mellitus in Primary Care: A Prospective Study Comparing the Diagnostic Capacity of an AI Algorithm

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 second part of the project will consist of the elaboration of a prospective study that will allow comparing the diagnostic capacity of the algorithm with that of the family medicine physicians and with retina specialists. The reference will be a blinded double reading conducted by the retina specialists (with a blinded third reading in case of disagreement in the previous 2 readings). In this way, the results obtained, both by the AI algorithm and by family medicine specialists, will be compared using the gold standard (accuracy, sensitivity, specificity, area under the curve, etc). The inclusion of nurses who received training in fundus readings will be considered to compare their diagnostic capacity.

Study Population, Site Participation, and Recruitment Images for the development of the algorithm will be ceded by the CHS and will include images from the whole Catalan population. The prospective study will take place in the primary care centers managed by the Catalan Health Institute in Central Catalonia, which includes the counties of Bages, Osona, Berguedà, and Anoia. The reference population will be the population assigned to these primary care centers. This population included about 512,000 people in 2017, with an estimated prevalence of diabetes of 7.1%.

The study period will include 2010-2017 for the development of the algorithm with AI. The prospective study will begin once the algorithm is developed and will run until the number of readings needed is obtained (about 3-4 months).

Conduct of the Study For the development of the AI algorithm, all fundus images labeled as DR of patients from primary care centers in Catalonia between 2010 and 2017 will be included. For the prospective study, all the images of patients who underwent an eye fundus examination will be included from the study start period until the adequate number of patients is reached. A high percentage of fundus images must have sufficient quality; that is, a 40-degree vision of the central retina where at least a three-fourth part of the optic nerve, a well-focused macula, and well-defined veins and arteries of the upper and lower arcs can be seen. Eye fundus images that do not have adequate technical quality (dark) or that cannot be evaluated due to the opacity of the media (eg, for cataracts) will be excluded

Data Collection For the development of the AI algorithm, it is necessary to have the anonymized images with the corresponding label that classifies each image (in one of the classes with which the algorithm is to be trained). The personnel responsible for information technology (IT) of the CHS will evaluate the best strategy for the anonymization and extraction of the images from the computer systems of the CHS, as well as the identification of each image with a unique identifier. On the other hand, a tabulated file type CSV or TXT will be required to relate each image identifier with the corresponding classification. The person responsible for IT of the CHS, together with the technical manager of OPTretina, will agree on the best way to transfer these 2 sources of information, in a secure way, from the CHS servers to the OPTretina servers (SSH File Transfer Protocol, external hard disk) depending on the volume of data to be transferred and the internal policy of the CHS. OPTretina is experienced in developing AI models for automatic fundus image classification and is a Spanish Agency of Medicines and Health Products-certified medical device manufacturer.

For the prospective study, anonymized weekly fundus data readings collected by family medicine physician readers of fundus images in Central Catalonia will be collected. The images will be transferred to the OPTretina servers to be first analyzed by the diagnostic algorithm and then by the retina specialists who will make the definitive diagnosis. The person responsible for IT of the CHS, together with the technical manager of OPTretina, will agree on the best way to transfer these data in a secure manner.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Manresa, Barcelona, Spain, 08242
        • CAP Bages

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of type I or type II diabetes mellitus
  • Fundus photograph taken as part of the screening for diabetic retinopathy

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: family medicine physicians
Retina reading
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
Experimental: retina specialists
Retina reading (gold standard)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of the algorithm
Time Frame: 1 year
True positive rate of the algorithm
1 year
Specificity of the algorithm
Time Frame: 1 year
True negative rate of the algorithm
1 year
Accuracy of the algorithm
Time Frame: 1 year
Ratio of number of correct predictions to the total number of input samples
1 year
Area under the receiver operating characteristic curve of the algorithm
Time Frame: 1 year
Diagnostic ability of the algorithm
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Institut Català de la Salut
Department of Health, Generalitat de Catalunya
OPTretina

Investigators

  • Study Chair: Josep Vidal-Alaball, MD, PhD, MPH, Institut Català de la Salut / IDIAP Jordi Gol
  • Principal Investigator: Alba Arocas Bonache, RN, Institut Català de la Salut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

September 26, 2023

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P18/109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The protocol has been published.

IPD Sharing Time Frame

End of the study

IPD Sharing Access Criteria

Information will be published in international scientific journals

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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