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

This study has been completed.
Sponsor:
Collaborators:
Fundação para a Ciência e a Tecnologia
Instituto Financeiro para o Desenvolvimento Regional
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT01220804
First received: October 11, 2010
Last updated: December 17, 2013
Last verified: September 2011
  Purpose

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).


Condition
Diabetic Retinopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:
  • Optical reflectivity as measured by optical coherence tomography [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    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


Enrollment: 30
Study Start Date: November 2010
Study Completion Date: March 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
NPDR
Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR)
Control Population
Healthy volunteers

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population).

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01220804

Locations
Portugal
AIBILI
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Fundação para a Ciência e a Tecnologia
Instituto Financeiro para o Desenvolvimento Regional
  More Information

Additional Information:
No publications provided

Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT01220804     History of Changes
Other Study ID Numbers: PTDC/SAU-BEB/103151/2008
Study First Received: October 11, 2010
Last Updated: December 17, 2013
Health Authority: Portugal: AIBILI-Health Ethic Committee

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014