Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography (CNTM025A OCT)
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography|
- 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
|Study Start Date:||November 2010|
|Study Completion Date:||March 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220804
|Coimbra, Portugal, 3000-548|