Trials / Completed
CompletedNCT01220804
Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- Association for Innovation and Biomedical Research on Light and Image · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2011-12-01
- Completion
- 2013-03-01
- First posted
- 2010-10-14
- Last updated
- 2016-04-25
Locations
1 site across 1 country: Portugal
Source: ClinicalTrials.gov record NCT01220804. Inclusion in this directory is not an endorsement.