Clinical trial NCT03437018: MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE
Official title: COMPARISON OF MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE AND CONVENTIONAL OPHTHALMOLOGICAL CONSULTATION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Keywords: moderate diabetic retinopathy
tele-expertise
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with complicated diabetes mellitus with moderate retinopathy requiring periodic follow-up by an ophthalmologist

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.

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

Primary outcomes:
measure: classification of diabetic retinopathy (DR)
timeFrame: 1 month
Secondary outcomes:
measure: classification of macular edema
timeFrame: 1 month
measure: follow-up strategy
timeFrame: 1 month
measure: medical time necessary for examination and analyse
timeFrame: 1 month
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Alfred Penfornis
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.