OCT Agreement and Crossed Precision Study

Sponsor
Nidek Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT02050880
Collaborator
(none)
119
1
5
24

Study Details

Study Description

Brief Summary

The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    119 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Crossed Precision Design Study of the Nidek Optical Coherence Tomography RS-3000, RS-3000 Lite and RS-3000 Advance for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, and Pachymetry
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Jun 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Normal eyes

    Eyes without pathology.

    Glaucoma

    Eyes with Glaucoma.

    Retinal

    Eyes with Retinal Disease.

    Corneal

    Eyes with corneal disease including a kerato-refractive group.

    Outcome Measures

    Primary Outcome Measures

    1. Retinal thickness [Approximately four hours]

      Time frame is the maximum duration of hospital stay

    2. Optic Disc Analysis [Approximately four hours]

      Time frame is the maximum duration of hospital stay

    3. Corneal Thickness [Approximately four hours]

      Time frame is the maximum duration of hospital stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria: NORMAL EYES

    • Subjects who do not have pathology in both eyes

    Inclusion Criteria: GLAUCOMA

    • Subjects who have a glaucoma diagnosis

    Inclusion Criteria: RETINAL

    • Subjects who have a retinal diagnosis including but not limited to:
    1. Diabetic macular edema

    2. Dry age related macular degeneration

    3. Wet age related macular degeneration

    4. Cystoid macular edema

    5. Epiretinal membrane

    6. Macular hole

    Inclusion Criteria: CORNEAL

    • Subjects who has one of these diagnosis:
    1. Post status LASIK surgery

    2. Keratoconus

    3. Other corneal dystrophies or degenerations.

    Exclusion Criteria: ALL EYES

    • Subjects who have any of the following conditions
    1. Diabetes mellitus (DM) and/or diabetic retinopathy

    2. Uncontrolled Hypertension (HT)

    3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision

    4. Cardiac, hepatic, renal and hematologic diseases

    5. A current condition requiring systemic administration of steroid

    6. A history of, or currently receiving, anticancer therapy

    7. Epileptic seizures which are optically induced

    8. Dementia

    • Subjects who have other life threatening and debilitating systemic diseases

    Note: Additional criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 WCCT Global Opthalmology Research Center Santa Ana California United States 92705

    Sponsors and Collaborators

    • Nidek Co. LTD.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nidek Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT02050880
    Other Study ID Numbers:
    • RS-3000 series Protocol 1
    First Posted:
    Jan 31, 2014
    Last Update Posted:
    Sep 29, 2014
    Last Verified:
    Sep 1, 2014

    Study Results

    No Results Posted as of Sep 29, 2014