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Function and Structure Imaging in Different Retinal Diseases: Retinal Leakage Analyzer Versus Optical Coherence Tomography

Sponsor
Association for Innovation and Biomedical Research on Light and Image (Other)
Overall Status
Completed
CT.gov ID
NCT00797524
Collaborator
(none)
35
Enrollment
1
Location
23
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    35 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Function and Structure Imaging in Different Retinal Diseases. Retinal Leakage Analyzer vs. Optical Coherence Tomography.
    Study Start Date :
    Nov 1, 2008
    Actual Primary Completion Date :
    Oct 1, 2010
    Actual Study Completion Date :
    Oct 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    DR

    Diabetic Retinopathy
    ARMD

    Age-Related Macular Degeneration
    ME

    Macular Edema

    Outcome Measures

    Primary Outcome Measures

    1. Retinal leakage and retinal thickness. [After the visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Diagnosis of DR, ARMD or ME

    • Females or Males

    • Age over 18 years

    • Signed Informed Consent Form

    Exclusion Criteria:

    • Cataract or other eye disease that may interfere with fundus examinations

    • Vitreous syneresis or posterior vitreous detachment

    • Dilatation of the pupil < 5 mm

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AIBILI Coimbra Portugal 3000-548

    Sponsors and Collaborators

    • Association for Innovation and Biomedical Research on Light and Image

    Investigators

    • Principal Investigator: José Cunha-Vaz, MD, PhD, Association for Innovation and Biomedical Research on Light and Image

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Association for Innovation and Biomedical Research on Light and Image
    ClinicalTrials.gov Identifier:
    NCT00797524
    Other Study ID Numbers:
    • 023RLAOCT
    First Posted:
    Nov 25, 2008
    Last Update Posted:
    Feb 3, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Macular Degeneration
    Macular Edema
    Retinal Diseases
    Diabetic Retinopathy

    Study Results

    No Results Posted as of Feb 3, 2015