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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01663688

Enrollment

279

Registered

2012-08-13

Start date

2012-07-31

Completion date

2013-08-31

Last updated

2014-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Physiology

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results