Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography
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Purpose
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).
| Condition |
|---|
|
Diabetic Retinopathy |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
NPDR
Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR)
|
|
Control Population
Healthy volunteers
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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 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.
Contacts and Locations| Portugal | |
| AIBILI | Recruiting |
| Coimbra, Portugal, 3000-548 | |
| Contact: Rui M Bernardes, PhD +351239480106 rcb@aibili.pt | |
| Contact +351239480108 seccntm@aibili.pt | |
| Principal Investigator: Rui Bernardes, PhD | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Association for Innovation and Biomedical Research on Light and Image |
| ClinicalTrials.gov Identifier: | NCT01220804 History of Changes |
| Other Study ID Numbers: | PTDC/SAU-BEB/103151/2008 |
| Study First Received: | October 11, 2010 |
| Last Updated: | September 22, 2011 |
| Health Authority: | Portugal: AIBILI-Health Ethic Committee |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013