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OCT Reference Database

Sponsor
Topcon Medical Systems, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01986478
Collaborator
(none)
389
Enrollment
5
Locations
5
Duration (Months)
77.8
Patients Per Site
15.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To collect data for a reference database.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Collection of multiple subjects to create a reference database.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    389 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Reference Database Study
    Study Start Date :
    Oct 1, 2013
    Actual Primary Completion Date :
    Mar 1, 2014
    Actual Study Completion Date :
    Mar 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Normal

    Normal results from clinical exam and free of ocular pathology

    Outcome Measures

    Primary Outcome Measures

    1. Retinal Thickness [Day 1]

    Eligibility Criteria

    Criteria

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

    1. Subjects 18 years of age or older on the date of informed consent

    2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent

    3. Subjects presenting at the site with normal eyes (eyes without pathology)

    4. IOP ≤ 21 mmHg bilaterally

    5. BCVA 20/40 or better (each eye)

    6. Both eyes must be free of eye disease

    Exclusion Criteria:

    1. Subjects unable to tolerate ophthalmic imaging

    2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images

    3. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5%

    4. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 33% or false positives > 25%, or false negatives > 25%

    5. Presence of any ocular pathology except for cataract

    6. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning

    7. Narrow angle

    8. History of leukemia, dementia or multiple sclerosis

    9. Concomitant use of hydroxychloroquine and chloroquine

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Horizon Eye Specialist & Laser Center Scottsdale Arizona United States 85054
    2 Valley Eyecare Center Livermore California United States 94550
    3 Keck School of Medicine Los Angeles California United States 90033
    4 Western University of Health Sciences Pomona California United States 91716
    5 Stat University of New York College of Optometry New York New York United States 10036

    Sponsors and Collaborators

    • Topcon Medical Systems, Inc.

    Investigators

    • Principal Investigator: Michael Sinai, PhD, Senior Manager Product Planning Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Topcon Medical Systems, Inc.
    ClinicalTrials.gov Identifier:
    NCT01986478
    Other Study ID Numbers:
    • DC-001
    First Posted:
    Nov 18, 2013
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022

    Study Results

    No Results Posted as of Jun 8, 2022