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Completed

NCT Number: NCT03437018

MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE

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

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moderate diabetic retinopathy follow-up by tele-expertise

Other

Consultation by an orthoptist to measure visual acuity, eye tone by pulsed air tonometer, and retinography images after pupillary dilatation (9 photographs: one of the posterior pole and 8 of the peripheral retina) and optical coherence tomography (OCT).

The results are immediately evaluated on site by an ophthalmologist. The results are sent through a secure online medical application to a diabetic retinopathy specialist ophthalmologist for evaluation.

Primary outcomes

  1. 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

Secondary outcomes

  1. classification of macular edema

    Time frame: 1 month

    macular edema (ME) is classified in 4 stages : no ME , mild ME, moderate ME, severe ME

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

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

Acronym: TELERETINODIAB

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 19, 2018
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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