MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE

NCT03437018 | Completed DMC

• 1 other identifier: 2017-A02329-44
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Retinopathy

Keywords

moderate diabetic retinopathy; tele-expertise

Outcome Measures

Primary Outcomes (1)

• classification of diabetic retinopathy (DR)

  DR is classified in 3 stages : moderate non proliferative DR, severe non proliferative DR, and proliferative DR

  1 month

Secondary Outcomes (3)

• classification of macular edema

  1 month

• follow-up strategy

  1 month

• medical time necessary for examination and analyse

  1 month

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• patient with complicated diabetes mellitus with moderate retinopathy

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

Related Publications (3)

• Schulze-Dobold C, Erginay A, Robert N, Chabouis A, Massin P. Ophdiat((R)): 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.

  PMID: 22765981 BACKGROUND

• 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.

  PMID: 19349202 BACKGROUND

• 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.

  PMID: 18424210 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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

Study Officials

• Alfred Penfornis

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 19, 2018
• Study Start: October 10, 2019
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)