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

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT01220804
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

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 coherence tomograph (OCT).

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; NPDR levels 10, 20 and 35/47 (ETDRS severity scale); and an area of retinal leakage of at least 25% of the RLA map (macular area).

Exclusion Criteria:

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

Study Timeline

• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Study Start: 2010-11
• Primary Completion: 2011-12
• Study Completion: 2013-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optical reflectivity as measured by optical coherence tomography	14 months	To analyse OCT reflectivity distribution between areas with and without fluorescein leakage in type 2 diabetic eyes. In previous studies our group found differences, when comparing the histograms of the optical reflectivity distribution, suggesting that the optical reflectivity, as measured by OCT, may change under BRB alterations

Trial Locations

Locations (1)

AIBILI; 🇵🇹 Coimbra, Portugal