Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography (CNTM025A OCT)
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|ClinicalTrials.gov Identifier: NCT01220804|
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : April 25, 2016
|Condition or disease|
Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population).
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).
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 :||Observational|
|Actual Enrollment :||30 participants|
|Observational Model:||Case Control|
|Official Title:||Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||March 2013|
Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR)
- 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
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
|Coimbra, Portugal, 3000-548|