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Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography (CNTM025A OCT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220804
First Posted: October 14, 2010
Last Update Posted: April 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: October 11, 2010
First Posted: October 14, 2010
Last Update Posted: April 25, 2016
Last Verified: April 2016

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