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CompletedNCT03437018TELERETINODIABUpdated May 22, 2026

MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE

An observational study in Diabetic Retinopathy, sponsored by Centre Hospitalier Sud Francilien. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Centre Hospitalier Sud Francilien · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
97
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Diabetic Retinopathy

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Keywords

  • moderate diabetic retinopathy
  • tele-expertise
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • patient with complicated diabetes mellitus with moderate retinopathy

Exclusion criteria

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
04

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
97 participants (actual)
Patient registry
No

Interventions

  • Othermoderate 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.

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What researchers measure

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

    Time frame: 1 month

Secondary outcomes

  1. classification of macular edema

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

    Time frame: 1 month

  2. follow-up strategy

    follow-up strategy can take to ways : no treatment required and continuation of the monitoring/ complementary exam or treatment required

    Time frame: 1 month

  3. medical time necessary for examination and analyse

    time necessary for direct examination and analyse by ophthalmologist on-site and time necessary for remote analyse are measured

    Time frame: 1 month

06

Study locations

1 site
  • Centre Hospitalier Sud Francilien
    Corbeil-Essonnes, 91106, France
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References and documents

Publications

  • 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. PubMed 22765981 ↗
  • 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. PubMed 19349202 ↗
  • 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. PubMed 18424210 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03437018
Lead sponsor
Centre Hospitalier Sud Francilien
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Oct 10, 2019
Primary completion
Jun 16, 2022
Completion
Jun 16, 2022
Last update
May 22, 2026

Study contacts

Alfred Penfornis
principal investigator · Centre Hospitalier Sud Francilien

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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