MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE

Diabetic Retinopathy Clinical Trial

— TELERETINODIAB  

Official title:

COMPARISON OF MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE AND CONVENTIONAL OPHTHALMOLOGICAL CONSULTATION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437018
• Other study ID #: ID RCB 2017-A02329-44
• Status: Completed
• Start date: October 10, 2019
• Est. completion date: June 16, 2022

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 16, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	classification of macular edema	macular edema (ME) is classified in 4 stages : no ME , mild ME, moderate ME, severe ME	1 month
Secondary	follow-up strategy	follow-up strategy can take to ways : no treatment required and continuation of the monitoring/ complementary exam or treatment required	1 month
Secondary	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	1 month