MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE

Overview

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

Full Title of Study: “COMPARISON OF MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE AND CONVENTIONAL OPHTHALMOLOGICAL CONSULTATION”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 13, 2022

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.

Interventions

  • Other: moderate diabetic retinopathy follow-up by tele-expertise
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • classification of macular edema
    • Time Frame: 1 month
    • macular edema (ME) is classified in 4 stages : no ME , mild ME, moderate ME, severe ME
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Sud Francilien
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alfred Penfornis, Principal Investigator, Centre Hospitalier Sud Francilien
  • Overall Contact(s)
    • François-Xavier Laborne, MD, +33169139597, fx.laborne@samu91.org

References

Schulze-Döbold C, Erginay A, Robert N, Chabouis A, Massin P. Ophdiat(®): five-year experience of a telemedical screening programme for diabetic retinopathy in Paris and the surrounding area. Diabetes Metab. 2012 Nov;38(5):450-7. doi: 10.1016/j.diabet.2012.05.003. Epub 2012 Jul 4.

Chabouis A, Berdugo M, Meas T, Erginay A, Laloi-Michelin M, Jouis V, Guillausseau PJ, M'bemba J, Chaine G, Slama G, Cohen R, Reach G, Marre M, Chanson P, Vicaut E, Massin P. Benefits of Ophdiat, a telemedical network to screen for diabetic retinopathy: a retrospective study in five reference hospital centres. Diabetes Metab. 2009 Jun;35(3):228-32. doi: 10.1016/j.diabet.2008.12.001. Epub 2009 Apr 5.

Erginay A, Chabouis A, Viens-Bitker C, Robert N, Lecleire-Collet A, Massin P. OPHDIAT: quality-assurance programme plan and performance of the network. Diabetes Metab. 2008 Jun;34(3):235-42. doi: 10.1016/j.diabet.2008.01.004.

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