MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT03437018
• Lead Sponsor: Centre Hospitalier Sud Francilien

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-19
• Study Start: 2019-10-10
• Primary Completion: 2022-06-16
• Study Completion: 2022-06-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• patient with complicated diabetes mellitus with moderate retinopathy

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
classification of diabetic retinopathy (DR)	1 month	DR is classified in 3 stages : moderate non proliferative DR, severe non proliferative DR, and proliferative DR

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France