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Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes (CORISMAP)

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ClinicalTrials.gov Identifier: NCT02876744
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term, a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. The accuracy of the analysis of the vascularization of retinal layers of the posterior pole of the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not there are areas of macular ischemia in a patient. However, current technical limitations (small field analysis) of OCT-A imaging only allow a limited study of retina at the posterior pole of the fundus.

This study seeks to demonstrate whether there is a link between macular ischemia detected by the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in diabetic patients.


Condition or disease Intervention/treatment
Diabetic Retinopathy Other: ophthalmologic examination

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: ophthalmologic examination
    ophthalmologic examination including optical coherent tomography with angiography module


Primary Outcome Measures :
  1. Detection and measure of ischemic territories in central and peripheral retina [ Time Frame: immediate ]


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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
Patients with diabetes, requiring follow-up with fluorescein angiography.
Criteria

Inclusion Criteria:

  • diabetes type I or type II
  • follow-up with fluorescein angiography

Exclusion Criteria:

  • known allergy to fluorescein
  • contra-indication to fluorescein angiography
  • pregnant or breast-feeding patient
  • technical impossibility to analyse retinal ischemic areas on fluorescein angiography or OCT-A.

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): NCT02876744


Contacts
Contact: Laurence SALOMON, MD, PhD 0033148036431 lsalomon@for.paris

Locations
France
Fondation Opthalmologique A de Rothschild Recruiting
Paris, France, 75019
Contact: Martine MAUGET FAYSSE         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Martine MAUGET FAYSSE, MD Fondation ophtalmologique de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02876744     History of Changes
Other Study ID Numbers: MMT_2016_21
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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