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

Ocular Physiology Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663688
• Other study ID #: OCT RS-3000
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: January 16, 2014
• Start date: July 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Nidek Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ocular Physiology

Locations

Country	Name	City	State
United States	UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology	La Jolla	California
United States	USC Eye Institute, Keck Medical Center of USC	Los Angeles	California
United States	UC Davis, Medical Center, Department of Ophthalmology & Vision Science	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Nidek Co. LTD.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Yes