Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 20 - Any |
| Updated: | 5/27/2013 |
| Start Date: | July 2012 |
| End Date: | March 2013 |
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.
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.
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.
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