MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE (TELERETINODIAB)

May 21, 2026 updated by: Centre Hospitalier Sud Francilien

COMPARISON OF MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE AND CONVENTIONAL OPHTHALMOLOGICAL CONSULTATION

The aim of this study is to evaluate the monitoring of moderate diabetic retinopathy by tele-expertise

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study compares 2 strategies of monitoring of moderate diabetic retinopathy (RD).After a consultation with an orthoptist for measurement of visual acuity, measurement of ocular tone by pulsed air tonometer, retinography pictures (9 photographs: one of the posterior pole and 8 of the retinal periphery) and Optical Coherence Tomography (OCT), results are evaluated on-site by an ophthalmologist and then sent through a secure medical online application to an ophthalmologist expert in RD for assessment. Each patient is his own control.

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

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

Study Locations

  • France
      • Corbeil-Essonnes, France, 91106
        • Centre Hospitalier Sud Francilien

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patient with complicated diabetes mellitus with moderate retinopathy requiring periodic follow-up by an ophthalmologist

Description

Inclusion Criteria:

  • patient with complicated diabetes mellitus with moderate retinopathy

Exclusion Criteria:

  • Patient deprived of liberty by judicial or administrative decision
  • Person subject to a legal protection measure
  • Patient already involved in another clinical trial protocol

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
classification of diabetic retinopathy (DR)
Time Frame: 1 month
DR is classified in 3 stages : moderate non proliferative DR, severe non proliferative DR, and proliferative DR
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
classification of macular edema
Time Frame: 1 month
macular edema (ME) is classified in 4 stages : no ME , mild ME, moderate ME, severe ME
1 month
follow-up strategy
Time Frame: 1 month
follow-up strategy can take to ways : no treatment required and continuation of the monitoring/ complementary exam or treatment required
1 month
medical time necessary for examination and analyse
Time Frame: 1 month
time necessary for direct examination and analyse by ophthalmologist on-site and time necessary for remote analyse are measured
1 month

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Alfred Penfornis, Centre Hospitalier Sud Francilien

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)

October 10, 2019

Primary Completion (Actual)

June 16, 2022

Study Completion (Actual)

June 16, 2022

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A02329-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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