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iCam Clinical Validation Study

Sponsor
Optovue (Industry)
Overall Status
Completed
CT.gov ID
NCT01600261
Collaborator
(none)
131
Enrollment
2
Locations
2
Duration (Months)
65.5
Patients Per Site
32.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Optovue has developed a new color fundus camera for imaging the eye with up to 45 degree field of view and without the use of dilating drops. The purpose of the study is to compare the image quality of the new camera with that of a commercially available color fundus camera. Consented subjects will undergo a general ophthalmic examination and series of fundus photography exams using the study device and comparison device. Photo image quality will be assessed for determination of clinically usefulness.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    131 participants
    Time Perspective:
    Prospective
    Official Title:
    iCam Clinical Validation Study
    Study Start Date :
    Apr 1, 2012
    Actual Primary Completion Date :
    May 1, 2012
    Actual Study Completion Date :
    Jun 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    eye exam

    Outcome Measures

    Primary Outcome Measures

    1. proportion of clinically useful images [Day 1]

    Eligibility Criteria

    Criteria

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

    • At least 18 years of age

    • Able and willing to complete the required examination

    Exclusion Criteria:

    • Spherical Equivalent outside -12 diopter to +15 diopter

    • Without lens

    • Inability to fixate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Livermore Optometry Group Livermore California United States 94550
    2 Buena Vista Eye Care San Jose California United States 95112

    Sponsors and Collaborators

    • Optovue

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Optovue
    ClinicalTrials.gov Identifier:
    NCT01600261
    Other Study ID Numbers:
    • 200-47425
    First Posted:
    May 17, 2012
    Last Update Posted:
    Jun 28, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by Optovue
    without eye disease
    Additional relevant MeSH terms:
    Eye Diseases

    Study Results

    No Results Posted as of Jun 28, 2012