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Nidek RS3000 Comparative Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.
ClinicalTrials.gov Identifier:
NCT01384487
First received: June 27, 2011
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Total Retinal Thickness [ Time Frame: One Visit ] [ Designated as safety issue: No ]
  • Inner Retinal Thickness [ Time Frame: One Visit ] [ Designated as safety issue: No ]
  • Outer Retinal Thickness [ Time Frame: One Visit ] [ Designated as safety issue: No ]
  • RNFL Thickness [ Time Frame: One Visit ] [ Designated as safety issue: No ]
  • Optic Disc Analysis [ Time Frame: One Visit ] [ Designated as safety issue: No ]
  • G Chart [ Time Frame: One Visit ] [ Designated as safety issue: No ]
  • Anterior Chamber Angle Image [ Time Frame: One Visit ] [ Designated as safety issue: No ]
  • SLO Image [ Time Frame: One Visit ] [ Designated as safety issue: No ]
  • Pachymetry [ Time Frame: One Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any adverse events [ Time Frame: One Visit ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nidek Co. LTD.
ClinicalTrials.gov Identifier: NCT01384487     History of Changes
Other Study ID Numbers: Nidek RS3000-1
Study First Received: June 27, 2011
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013