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

Normative Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for the Measurements of Retinal and RNFL Thickness and Optic Disc Analysis

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.

Study Overview

• Status: Completed
• Conditions: Ocular Physiology

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.

• Study Type: Observational
• Enrollment (Actual): 279

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology
    • Los Angeles, California, United States, 90033
      • USC Eye Institute, Keck Medical Center of USC
    • Sacramento, California, United States, 95817
      • UC Davis, Medical Center, Department of Ophthalmology & Vision Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal subject eyes

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Normative Data Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis	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.	Subjects will be followed for the duration of the procedure, up to one day.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of adverse events found during the clinical study	The secondary objective is to evaluate any adverse events found during the clinical study.	Subjects will be followed for the duration of the procedure, up to one day.

Collaborators and Investigators

• Sponsor: Nidek Co. LTD.
• Investigators: Principal Investigator: Robert N Weinreb, MD, Hamilton Glaucoma Center, UC San Diego

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (Estimate): August 13, 2012

Study Record Updates

• Last Update Posted (Estimate): January 20, 2014
• Last Update Submitted That Met QC Criteria: January 16, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: OCT RS-3000