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MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE (TELERETINO)

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ClinicalTrials.gov Identifier: NCT03437018
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Sud Francilien

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

Condition or disease Intervention/treatment
Diabetic Retinopathy Other: moderate diabetic retinopathy follow-up 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: COMPARISON OF MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE AND CONVENTIONAL OPHTHALMOLOGICAL CONSULTATION
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.



Primary Outcome Measures :
  1. classification of diabetic retinopathy (DR) [ Time Frame: 1 month ]
    DR is classified in 3 stages : moderate non proliferative DR, severe non proliferative DR, and proliferative DR


Secondary Outcome Measures :
  1. classification of macular edema [ Time Frame: 1 month ]
    macular edema (ME) is classified in 4 stages : no ME , mild ME, moderate ME, severe ME

  2. follow-up strategy [ Time Frame: 1 month ]
    follow-up strategy can take to ways : no treatment required and continuation of the monitoring/ complementary exam or treatment required

  3. medical time necessary for examination and analyse [ Time Frame: 1 month ]
    time necessary for direct examination and analyse by ophthalmologist on-site and time necessary for remote analyse are measured



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437018


Contacts
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Contact: François-Xavier Laborne +33169139597 fx.laborne@samu91.org
Contact: Dalia Mignot +33161693730 dalia.mignot@chsf.fr

Sponsors and Collaborators
Centre Hospitalier Sud Francilien
Investigators
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Principal Investigator: Alfred Penfornis Centre Hospitalier Sud Francilien

Publications:
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Responsible Party: Centre Hospitalier Sud Francilien
ClinicalTrials.gov Identifier: NCT03437018     History of Changes
Other Study ID Numbers: ID RCB 2017-A02329-44
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Sud Francilien:
moderate diabetic retinopathy
tele-expertise

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases