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Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye

Sponsor
Nidek Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT01663688
Collaborator
(none)
279
Enrollment
3
Locations
13
Duration (Months)
93
Patients Per Site
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to collect and evaluate the data from eye scans using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique that uses invisible wavelengths of light to make detailed images of the tissues at the back of the eye. These images provide information that physicians may use to help diagnose eye conditions and/or to monitor changes in the eye during treatment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective, open-labeled, multi-center clinical study. After qualifying examination of a subject, 3D retinal measurement in the proximity of the optic disc and the macula are carried out for eligible subjects with normal eyes using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) etc. using the Nidek Optical Coherence Tomography (OCT) RS-3000 with normative database. The secondary objective is to evaluate any adverse events found during the clinical study.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    279 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Normative Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for the Measurements of Retinal and RNFL Thickness and Optic Disc Analysis
    Study Start Date :
    Jul 1, 2012
    Actual Primary Completion Date :
    Jun 1, 2013
    Actual Study Completion Date :
    Aug 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Normative Data Collection

    Outcome Measures

    Primary Outcome Measures

    1. Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis [Subjects will be followed for the duration of the procedure, up to one day.]

      The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL)and Optic Disc Analysis.

    Secondary Outcome Measures

    1. Evaluation of adverse events found during the clinical study [Subjects will be followed for the duration of the procedure, up to one day.]

      The secondary objective is to evaluate any adverse events found during the clinical study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Normal and healthy male and female subjects at least 20 years of age.

    Exclusion Criteria

    • Subjects who have extensive or debilitating systemic diseases.

    • Subjects who have significant ocular disease.

    • Subjects who are extremely far sighted or extremely near sighted.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology La Jolla California United States 92093
    2 USC Eye Institute, Keck Medical Center of USC Los Angeles California United States 90033
    3 UC Davis, Medical Center, Department of Ophthalmology & Vision Science Sacramento California United States 95817

    Sponsors and Collaborators

    • Nidek Co. LTD.

    Investigators

    • Principal Investigator: Robert N Weinreb, MD, Hamilton Glaucoma Center, UC San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nidek Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT01663688
    Other Study ID Numbers:
    • OCT RS-3000
    First Posted:
    Aug 13, 2012
    Last Update Posted:
    Jan 20, 2014
    Last Verified:
    Jan 1, 2014

    Study Results

    No Results Posted as of Jan 20, 2014