OCT Agreement and Crossed Precision Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02050880
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : September 29, 2014
Information provided by (Responsible Party):
Nidek Co. LTD.

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
Glaucoma Retinal Disease Corneal Disease

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 : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Normal eyes
Eyes without pathology.
Eyes with Glaucoma.
Eyes with Retinal Disease.
Eyes with corneal disease including a kerato-refractive group.

Primary Outcome Measures :
  1. Retinal thickness [ Time Frame: Approximately four hours ]
    Time frame is the maximum duration of hospital stay

  2. Optic Disc Analysis [ Time Frame: Approximately four hours ]
    Time frame is the maximum duration of hospital stay

  3. Corneal Thickness [ Time Frame: Approximately four hours ]
    Time frame is the maximum duration of hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Clinic subjects, general population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02050880

United States, California
WCCT Global Opthalmology Research Center
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Nidek Co. LTD.

Responsible Party: Nidek Co. LTD. Identifier: NCT02050880     History of Changes
Other Study ID Numbers: RS-3000 series Protocol 1
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: September 29, 2014
Last Verified: September 2014

Keywords provided by Nidek Co. LTD.:
Normal Eyes
Eye; Disorder with Glaucoma
Eye; Disorder with Retinal Disease
Eye; Disorder Corneal Disease incl kerato-refractive group

Additional relevant MeSH terms:
Retinal Diseases
Corneal Diseases
Ocular Hypertension
Eye Diseases