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OpenTrials
Completed

NCT Number: NCT02876744

Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Opthalmologique A de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ophthalmologic examination

Other

ophthalmologic examination including optical coherent tomography with angiography module

Primary outcomes

  1. Detection and measure of ischemic territories in central and peripheral retina

    Time frame: immediate

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: CORISMAP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 24, 2016
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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