We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nidek RS3000 Comparative Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384487
First Posted: June 29, 2011
Last Update Posted: February 20, 2012
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.
Information provided by (Responsible Party):
Nidek Co. LTD.
  Purpose
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
Glaucoma Retinal Disease Corneal Disease

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Nidek Co. LTD.:

Primary Outcome Measures:
  • Total Retinal Thickness [ Time Frame: One Visit ]
  • Inner Retinal Thickness [ Time Frame: One Visit ]
  • Outer Retinal Thickness [ Time Frame: One Visit ]
  • RNFL Thickness [ Time Frame: One Visit ]
  • Optic Disc Analysis [ Time Frame: One Visit ]
  • G Chart [ Time Frame: One Visit ]
  • Anterior Chamber Angle Image [ Time Frame: One Visit ]
  • SLO Image [ Time Frame: One Visit ]
  • Pachymetry [ Time Frame: One Visit ]

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

Enrollment: 89
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal Eyes
Eyes without disease
Eyes with Glaucoma
Eyes with Retinal Disease
Eyes with Corneal Disease
Including post keratorefractive surgery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01384487


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

Responsible Party: Nidek Co. LTD.
ClinicalTrials.gov Identifier: NCT01384487     History of Changes
Other Study ID Numbers: Nidek RS3000-1
First Submitted: June 27, 2011
First Posted: June 29, 2011
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