Nidek RS3000 Comparative 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: NCT01384487
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : February 20, 2012
Information provided by (Responsible Party):
Nidek Co. LTD.

Brief Summary:
The primary objective of this clinical study is to compare the Nidek RS-3000 Optical Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to evaluate any adverse events found during the clinical study.

Condition or disease
Glaucoma Retinal Disease Corneal Disease

Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparative Study of the Nidek Optical Coherence Tomography RS-3000 and the RTVue OCT Predicate Device for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, Pachymetry, Anterior Chamber Imaging and SLO Imaging.
Study Start Date : June 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Normal Eyes
Eyes without disease
Eyes with Glaucoma
Eyes with Retinal Disease
Eyes with Corneal Disease
Including post keratorefractive surgery

Primary Outcome Measures :
  1. Total Retinal Thickness [ Time Frame: One Visit ]
  2. Inner Retinal Thickness [ Time Frame: One Visit ]
  3. Outer Retinal Thickness [ Time Frame: One Visit ]
  4. RNFL Thickness [ Time Frame: One Visit ]
  5. Optic Disc Analysis [ Time Frame: One Visit ]
  6. G Chart [ Time Frame: One Visit ]
  7. Anterior Chamber Angle Image [ Time Frame: One Visit ]
  8. SLO Image [ Time Frame: One Visit ]
  9. Pachymetry [ Time Frame: One Visit ]

Secondary Outcome Measures :
  1. Any adverse events [ Time Frame: One Visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

Inclusion Criteria:

  1. Subjects of legal age and who have full legal capacity to volunteer on the date the informed consent is signed.
  2. Subjects who follow the instructions by Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.
  3. Subjects who sign an informed consent form to participate in the clinical study.
  4. Subjects who agree to take the qualifying examination and RS-3000 and RTVue data acquisition.

Exclusion Criteria:

  1. Diabetes mellitus (DM) and/or diabetic retinopathy
  2. 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. Current systemic administration of steroid
  6. History of anticancer agent etc.
  7. Optically-stimulated epileptic seizure
  8. Dementia
  9. Subjects who have other life threatening and debilitating systemic diseases

NOTE: Additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist

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): NCT01384487

United States, California
Hamilton Glaucoma Center
La Jolla, California, United States, 92093-0946
Sponsors and Collaborators
Nidek Co. LTD.
Principal Investigator: Robert Weinreb, M.D. UCSD, Hamilton Glaucoma Center

Responsible Party: Nidek Co. LTD. Identifier: NCT01384487     History of Changes
Other Study ID Numbers: Nidek RS3000-1
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012

Keywords provided by Nidek Co. LTD.:
Viewing and axial cross sectional imaging of ocular
structures, including the anterior chamber

Additional relevant MeSH terms:
Retinal Diseases
Corneal Diseases
Eye Diseases