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

Completed

• Conditions: Ocular Physiology

• Registration Number: NCT01663688
• Lead Sponsor: Nidek Co. LTD.

Brief Summary

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.

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-13
• Primary Completion: 2013-06
• Study Completion: 2013-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-16
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of 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.	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

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

Trial Locations

Locations (3)

USC Eye Institute, Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States

UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology; 🇺🇸 La Jolla, California, United States

UC Davis, Medical Center, Department of Ophthalmology & Vision Science; 🇺🇸 Sacramento, California, United States