Clinical trial NCT01663688: Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Physiology
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 279
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal subject eyes

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis
timeFrame: Subjects will be followed for the duration of the procedure, up to one day.
Secondary outcomes:
measure: Evaluation of adverse events found during the clinical study
timeFrame: Subjects will be followed for the duration of the procedure, up to one day.
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology
state: California
city: Los Angeles
country: United States
facility: USC Eye Institute, Keck Medical Center of USC
state: California
city: Sacramento
country: United States
facility: UC Davis, Medical Center, Department of Ophthalmology & Vision Science
state: California
Study officials:
affiliation: Hamilton Glaucoma Center, UC San Diego
name: Robert N Weinreb, MD
role: PRINCIPAL_INVESTIGATOR
References: