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
1 other identifier
observational
279
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2012
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJanuary 20, 2014
January 1, 2014
11 months
July 12, 2012
January 16, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
Evaluation of adverse events found during the clinical study
Subjects will be followed for the duration of the procedure, up to one day.
Study Arms (1)
Normative Data Collection
Eligibility Criteria
Normal subject eyes
You may qualify if:
- Normal and healthy male and female subjects at least 20 years of age.
You may not qualify if:
- Subjects who have extensive or debilitating systemic diseases.
- Subjects who have significant ocular disease.
- Subjects who are extremely far sighted or extremely near sighted.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nidek Co. LTD.lead
Study Sites (3)
UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology
La Jolla, California, 92093, United States
USC Eye Institute, Keck Medical Center of USC
Los Angeles, California, 90033, United States
UC Davis, Medical Center, Department of Ophthalmology & Vision Science
Sacramento, California, 95817, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Robert N Weinreb, MD
Hamilton Glaucoma Center, UC San Diego
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2012
First Posted
August 13, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2013
Study Completion
August 1, 2013
Last Updated
January 20, 2014
Record last verified: 2014-01