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NCT01220804 Clinical Trial

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

Diabetic Retinopathy Clinical Trial

— CNTM025A OCT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01220804
Other study ID # PTDC/SAU-BEB/103151/2008
Secondary ID
Status Completed
Phase N/A
First received October 11, 2010
Last updated April 22, 2016
Start date November 2010
Est. completion date March 2013

Study information
Verified date April 2016
Source Association for Innovation and Biomedical Research on Light and Image
Contact n/a
Is FDA regulated No
Health authority Portugal: AIBILI-Health Ethic Committee
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2013
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Portugal AIBILI Coimbra

Sponsors (3)
Lead Sponsor Collaborator
Association for Innovation and Biomedical Research on Light and Image Fundação para a Ciência e a Tecnologia, Instituto Financeiro para o Desenvolvimento Regional

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Optical reflectivity as measured by optical coherence tomography 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 14 months No
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