Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes

NCT ID: NCT02876744

Last Updated: 2021-01-14

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

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-04

Study Completion Date

2020-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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ophthalmologic examination

ophthalmologic examination including optical coherent tomography with angiography module

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martine MAUGET FAYSSE, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation ophtalmologique de Rothschild

Locations

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Fondation Opthalmologique A de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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MMT_2016_21

Identifier Type: -

Identifier Source: org_study_id

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