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

October 11, 2010
December 17, 2013
November 2010
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01220804 on ClinicalTrials.gov Archive Site
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Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography
Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography

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).

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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

Diabetic Retinopathy
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  • NPDR
    Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR)
  • Control Population
    Healthy volunteers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2013
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01220804
PTDC/SAU-BEB/103151/2008
No
Association for Innovation and Biomedical Research on Light and Image
Association for Innovation and Biomedical Research on Light and Image
  • Fundação para a Ciência e a Tecnologia
  • Instituto Financeiro para o Desenvolvimento Regional
Not Provided
Association for Innovation and Biomedical Research on Light and Image
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP