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Discriminating Ability of the Cirrus High Definition (HD) Optical Coherence Tomography (OCT) for Glaucoma

Sponsor
Yonsei University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00742378
Collaborator
(none)
200
Enrollment
1
Location
3
Duration (Months)
66.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Cirrus HD OCT, a new spectral domain optical coherence tomography, has better resolution than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for glaucoma detection will be studied.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Cirrus HD OCT is a newly developed imaging device of the spectral domain optical coherence tomography. Even though its resolution and speed are much better than the previous OCT, its reproducibility and diagnostic power for detecting the glaucomatous defect of retinal nerve fiber layer (RNFL) have not known yet. In the present study, we will review the data of RNFL thickness measurement using the Cirrus HD OCT. After assessing the inter-test variability, the discriminating ability of the Cirrus HD OCT for glaucoma diagnosis will be determined by the ROC curves.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Discriminating Ability of the Cirrus HD OCT for Glaucoma
    Study Start Date :
    Sep 1, 2008
    Anticipated Primary Completion Date :
    Oct 1, 2008
    Anticipated Study Completion Date :
    Dec 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    C

    Normal controls
    G

    Glaucoma

    Outcome Measures

    Primary Outcome Measures

    1. Retinal nerve fiber layer thickness [when the OCT images are taking]

    Secondary Outcome Measures

    1. Red-free fundus photo [when the OCT images are taking]

    2. Visual field [when the OCT images are taking]

    3. Intraocular pressure [when the OCT images are taking]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Cooperative patients

    • Repeated OCT data

    Exclusion Criteria:

    • Intraocular surgeries history

    • DM

    • High refractive error ( < -4.00 diopters, or > + 4.00 diopters)

    • Media opacity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gong Je Seong Seoul Korea, Republic of 135-720

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Gong Je Seong, MD, PhD, Yonsei University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00742378
    Other Study ID Numbers:
    • 3-2008-0076-Reproducibility
    First Posted:
    Aug 27, 2008
    Last Update Posted:
    Sep 23, 2008
    Last Verified:
    Sep 1, 2008
    Keywords provided by , ,
    Glaucoma
    Retinal nerve fiber layer
    Cirrus OCT
    Additional relevant MeSH terms:
    Glaucoma

    Study Results

    No Results Posted as of Sep 23, 2008