Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma

Sponsor
Carl Zeiss Meditec, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01272102
Collaborator
DataMed Devices Inc. (Industry)
119
4
3.9
29.8
7.5

Study Details

Study Description

Brief Summary

To determine the area under the Receiver Operator Characteristic Curve (AUC) for the Ganglion Cell Analysis (GCA) average thickness.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To determine the area under the Receiver Operator Characteristic Curve (AUC) for the following GCA parameters:

    1. Minimum thickness

    2. Supero-temporal thickness

    3. Superior thickness

    4. Supero-nasal thickness

    5. Infero-temporal thickness

    6. Inferior thickness

    7. Infero-nasal thickness

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    119 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma
    Study Start Date :
    Nov 1, 2010
    Actual Primary Completion Date :
    Mar 1, 2011
    Actual Study Completion Date :
    Mar 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Glaucoma

    subjects with glaucoma

    Outcome Measures

    Primary Outcome Measures

    1. To determine the area under the Receiver Operator Characteristic Curve (AUC) for the GCA average thickness, and 7 more GCA parameters. [Study was released before December 1, 2012]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age of 40 years or older

    • Diagnosed to have glaucoma by the Principal Investigator or co-investigator

    • Able and willing to make the required study visits

    • Able and willing to give consent and follow study instructions

    Exclusion Criteria:
    Ophthalmic:
    • Best corrected visual acuity in either eye worse than 20/40 on a Snellen chart or on a Snellen equivalent acuity chart.

    • Refractive error outside -12.00D to +8.00D spherical range or >-3.00D cylinder.

    • Previous vitreoretinal surgery in study eye.

    • Vitreoretinal traction or epiretinal membrane in the study eye.

    • Any active infection of anterior or posterior segments.

    • Evidence of diabetic retinopathy, diabetic macular edema, or other vitreoretinal disease in the study eye upon dilated examination, or upon evaluation of retinal photos.

    Systemic:
    • History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis.

    • A life threatening or debilitating disease.

    • Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved or cleared investigational device (IDE).

    • Current or recent (within the past 14 days) use of an agent with photosensitizing properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline, etc.).

    • Concomitant use of hydrochloroquine and/or chloroquine.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Eye Institute Palo Alto California United States 94303
    2 Bascom Palmer Eye Institute Miami Florida United States 33136
    3 Glaucoma Associates of Texas Dallas Texas United States 75231
    4 Utah Eye Institute Salt Lake City Utah United States 84107

    Sponsors and Collaborators

    • Carl Zeiss Meditec, Inc.
    • DataMed Devices Inc.

    Investigators

    • Principal Investigator: Donald Budenz, MD, Bascom Palmer Eye Institute
    • Principal Investigator: Robert Chang, MD, Stanford Eye Institute
    • Principal Investigator: Arvind Neelakantan, MD, Glaucoma Associates of Texas
    • Principal Investigator: Alan Crandall, MD, Utah Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Carl Zeiss Meditec, Inc.
    ClinicalTrials.gov Identifier:
    NCT01272102
    Other Study ID Numbers:
    • HD-OCT-GCA-2010-1
    First Posted:
    Jan 7, 2011
    Last Update Posted:
    Jun 25, 2013
    Last Verified:
    Jun 1, 2013
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 25, 2013