Function and Structure Imaging in Different Retinal Diseases: Retinal Leakage Analyzer Versus Optical Coherence Tomography
1 other identifier
observational
35
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 24, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFebruary 3, 2015
February 1, 2015
1.9 years
November 24, 2008
February 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Retinal leakage and retinal thickness.
After the visit
Study Arms (3)
DR
Diabetic Retinopathy
ARMD
Age-Related Macular Degeneration
ME
Macular Edema
Eligibility Criteria
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.
You may qualify if:
- Diagnosis of DR, ARMD or ME
- Females or Males
- Age over 18 years
- Signed Informed Consent Form
You may not qualify if:
- Cataract or other eye disease that may interfere with fundus examinations
- Vitreous syneresis or posterior vitreous detachment
- Dilatation of the pupil \< 5 mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AIBILI
Coimbra, Coimbra District, 3000-548, Portugal
Related Publications (1)
Bernardes R, Maduro C, Serranho P, Araujo A, Barbeiro S, Cunha-Vaz J. Improved adaptive complex diffusion despeckling filter. Opt Express. 2010 Nov 8;18(23):24048-59. doi: 10.1364/OE.18.024048.
PMID: 21164752DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José Cunha-Vaz, MD, PhD
Association for Innovation and Biomedical Research on Light and Image
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2008
First Posted
November 25, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
February 3, 2015
Record last verified: 2015-02