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

This study is currently recruiting participants.

Verified September 2011 by Association for Innovation and Biomedical Research on Light and Image

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: September 22, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 11, 2010
Last Updated Date	September 22, 2011
Start Date ^ICMJE	November 2010
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 13, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01220804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography
Official Title ^ICMJE	Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population).
Condition ^ICMJE	Diabetic Retinopathy
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	NPDR Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) Control Population Healthy volunteers
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	March 2013
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Portugal

Administrative Information
NCT Number ^ICMJE	NCT01220804
Other Study ID Numbers ^ICMJE	PTDC/SAU-BEB/103151/2008
Has Data Monitoring Committee	No
Responsible Party	Association for Innovation and Biomedical Research on Light and Image
Study Sponsor ^ICMJE	Association for Innovation and Biomedical Research on Light and Image
Collaborators ^ICMJE	Fundação para a Ciência e a Tecnologia Instituto Financeiro para o Desenvolvimento Regional
Investigators ^ICMJE	Not Provided
Information Provided By	Association for Innovation and Biomedical Research on Light and Image
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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