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NCT02876744 Clinical Trial

Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes

Diabetic Retinopathy Clinical Trial

— CORISMAP  

Official title:
Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02876744
Other study ID # MMT_2016_21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 4, 2017
Est. completion date December 15, 2020

Study information
Verified date January 2021
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date December 15, 2020
Est. primary completion date April 13, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Fondation Opthalmologique A de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection and measure of ischemic territories in central and peripheral retina immediate
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