Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.
ClinicalTrials.gov Identifier:
NCT01663688
First received: July 12, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

The purpose of this clinical study is to collect and evaluate the data from eye scans using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique that uses invisible wavelengths of light to make detailed images of the tissues at the back of the eye. These images provide information that physicians may use to help diagnose eye conditions and/or to monitor changes in the eye during treatment.


Condition
Ocular Physiology

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Normative Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for the Measurements of Retinal and RNFL Thickness and Optic Disc Analysis

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

Primary Outcome Measures:
  • Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis [ Time Frame: Subjects will be followed for the duration of the procedure, up to one day. ] [ Designated as safety issue: No ]
    The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL)and Optic Disc Analysis.


Secondary Outcome Measures:
  • Evaluation of adverse events found during the clinical study [ Time Frame: Subjects will be followed for the duration of the procedure, up to one day. ] [ Designated as safety issue: Yes ]
    The secondary objective is to evaluate any adverse events found during the clinical study.


Enrollment: 279
Study Start Date: July 2012
Study Completion Date: August 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normative Data Collection

Detailed Description:

This is a prospective, open-labeled, multi-center clinical study. After qualifying examination of a subject, 3D retinal measurement in the proximity of the optic disc and the macula are carried out for eligible subjects with normal eyes using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) etc. using the Nidek Optical Coherence Tomography (OCT) RS-3000 with normative database. The secondary objective is to evaluate any adverse events found during the clinical study.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal subject eyes

Criteria

Inclusion Criteria:

  • Normal and healthy male and female subjects at least 20 years of age.

Exclusion Criteria

  • Subjects who have extensive or debilitating systemic diseases.
  • Subjects who have significant ocular disease.
  • Subjects who are extremely far sighted or extremely near sighted.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663688

Locations
United States, California
UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology
La Jolla, California, United States, 92093
USC Eye Institute, Keck Medical Center of USC
Los Angeles, California, United States, 90033
UC Davis, Medical Center, Department of Ophthalmology & Vision Science
Sacramento, California, United States, 95817
Sponsors and Collaborators
Nidek Co. LTD.
Investigators
Principal Investigator: Robert N Weinreb, MD Hamilton Glaucoma Center, UC San Diego
  More Information

No publications provided

Responsible Party: Nidek Co. LTD.
ClinicalTrials.gov Identifier: NCT01663688     History of Changes
Other Study ID Numbers: OCT RS-3000
Study First Received: July 12, 2012
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014