MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE

NCT ID: NCT03437018

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-10

Study Completion Date

2022-06-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Sud Francilien

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfred Penfornis

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

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Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 22765981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19349202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18424210 (View on PubMed)

Other Identifiers

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ID RCB 2017-A02329-44

Identifier Type: -

Identifier Source: org_study_id

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