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| Sponsored by: |
Association for Innovation and Biomedical Research on Light and Image |
|---|---|
| Information provided by: | Association for Innovation and Biomedical Research on Light and Image |
| ClinicalTrials.gov Identifier: | NCT00797524 |
Purpose
The main objective of this observational study is to characterize and correlate functional and structural changes at the retinal level using the Retinal Leakage Analyzer (RLA) and the Optical Coherence Tomograph (OCT).
To show if it is possible to use OCT as an indirect measurement of leakage, this study will check, in a primary analysis, for OCT changes between fluorescein leaking and non-leaking areas (identified by Retinal Leakage Analyzer).
As a secondary objective, changes in RLA and OCT over time (between two consecutive visits) will be analyzed and characterized.
The results of this study will be used exclusively for scientific purposes.
| Condition |
|---|
|
Diabetic Retinopathy Age-Related Macular Degeneration Macular Edema |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Function and Structure Imaging in Different Retinal Diseases. Retinal Leakage Analyzer vs. Optical Coherence Tomography. |
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | November 2010 |
| Groups/Cohorts |
|---|
|
DR
Diabetic Retinopathy
|
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ARMD
Age-Related Macular Degeneration
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ME
Macular Edema
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center (Azinhaga de Santa Comba - Celas, Coimbra, Portugal), performing, as part of their follow-up, fluorescein angiography with the Heidelberg Retina Angiograph (HRA) and optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: AIBILI CEC | +351239480100 | aibili@aibili.pt |
| Contact: AIBILI CNTM | +315239480108 | seccntm@aibili.pt |
| Portugal | |
| AIBILI | Recruiting |
| Coimbra, Portugal, 3000-548 | |
| Contact: AIBILI CEC aibili@aibili.pt | |
| Contact: AIBILI CNTM seccntm@aibili.pt | |
| Principal Investigator: José Cunha-Vaz, MD, PhD | |
| Sub-Investigator: Rui Bernardes, PhD | |
| Principal Investigator: | José Cunha-Vaz, MD, PhD | Association for Innovation and Biomedical Research on Light and Image |
More Information
| Responsible Party: | AIBILI ( José Cunha-Vaz, MD, PhD ) |
| Study ID Numbers: | 023RLAOCT |
| Study First Received: | November 24, 2008 |
| Last Updated: | November 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00797524 |
| Health Authority: | Portugal: Health Ethic Committee |
|
Eye Diseases Vascular Diseases Diabetes Mellitus Macular Degeneration Edema Endocrine System Diseases Retinal Degeneration |
Diabetic Angiopathies Macular Edema Diabetic Retinopathy Endocrinopathy Retinal Diseases Diabetes Complications Retinal degeneration |
|
Cardiovascular Diseases |
