TELERETINODIAB: MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE
Study Details
Study Description
Brief Summary
The aim of this study is to evaluate the monitoring of moderate diabetic retinopathy by tele-expertise
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- classification of macular edema [1 month]
macular edema (ME) is classified in 4 stages : no ME , mild ME, moderate ME, severe ME
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- patient with complicated diabetes mellitus with moderate retinopathy
Exclusion Criteria:
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Patient deprived of liberty by judicial or administrative decision
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Person subject to a legal protection measure
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Patient already involved in another clinical trial protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France | 91106 |
Sponsors and Collaborators
- Centre Hospitalier Sud Francilien
Investigators
- Principal Investigator: Alfred Penfornis, Centre Hospitalier Sud Francilien
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- ID RCB 2017-A02329-44