Status:

COMPLETED

Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography

Lead Sponsor:

Association for Innovation and Biomedical Research on Light and Image

Collaborating Sponsors:

Fundação para a Ciência e a Tecnologia

Instituto Financeiro para o Desenvolvimento Regional

Conditions:

Diabetic Retinopathy

Eligibility:

All Genders

18+ years

Brief Summary

The purpose of this study is to identify alterations of the blood-retinal barrier (BRB) in diabetic retinas using a novel non-invasive approach based on the Fourier domain high-definition optical cohe...

Detailed Description

Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population). Inclusion Criteria: Age over 18 years; type-2 diabetes; NPD...

Eligibility Criteria

Inclusion

  • Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale), and area of retinal leakage of at least 25% of the RLA map (macular area).

Exclusion

  • Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications.

Key Trial Info

Start Date :

November 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2013

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT01220804

Start Date

November 1 2010

End Date

March 1 2013

Last Update

April 25 2016

Active Locations (1)

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AIBILI

Coimbra, Portugal, 3000-548