Skip to main content
Clinical Trials/NCT03437018
NCT03437018
Completed
Not Applicable

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

Centre Hospitalier Sud Francilien1 site in 1 country97 target enrollmentOctober 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Retinopathy
Sponsor
Centre Hospitalier Sud Francilien
Enrollment
97
Locations
1
Primary Endpoint
classification of diabetic retinopathy (DR)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2019
End Date
June 16, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • follow-up strategy(1 month)
  • classification of macular edema(1 month)
  • medical time necessary for examination and analyse(1 month)

Study Sites (1)

Loading locations...

Similar Trials