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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01663688
Other study ID # OCT RS-3000
Secondary ID
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


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
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