Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye
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Purpose
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.
| Condition |
|---|
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Ocular Physiology |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
- Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis [ Time Frame: Subjects will be followed for the duration of the procedure, up to one day. ] [ Designated as safety issue: No ]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.
- Evaluation of adverse events found during the clinical study [ Time Frame: Subjects will be followed for the duration of the procedure, up to one day. ] [ Designated as safety issue: Yes ]The secondary objective is to evaluate any adverse events found during the clinical study.
| Estimated Enrollment: | 394 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Normative Data Collection |
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| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Normal subject eyes
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.
Contacts and Locations| United States, California | |
| UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology | Recruiting |
| La Jolla, California, United States, 92037-0946 | |
| Contact: Robert N Weinreb, M.D. 858-534-8824 rweinreb@ucsd.edu | |
| Contact: Eunice Williams-Steppe 858-822-1133 emwilliamssteppe@ucsd.edu | |
| Principal Investigator: Robert N Weinreb, M.D. | |
| USC, Doheny Eye Institute | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: SriniVas Sadda, M.D. 323-442-6503 sadda@usc.edu | |
| Contact: Sylvia L Ramos 323-442-6383 SRamos@doheny.org | |
| Principal Investigator: SriniVas Sadda, M.D. | |
| UC Davis, Medical Center, Department of Ophthalmology & Vision Science | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Michele C Lim, M.D. 916-734-6204 michele.lim@ucdmc.ucdavis.edu | |
| Contact: Barbara Holderreed 916-734-6303 baholderreed@ucdavis.edu | |
| Principal Investigator: Michele C Lim, M.D. | |
| Principal Investigator: | Robert N Weinreb, MD | Hamilton Glaucoma Center, UC San Diego |
More Information
No publications provided
| Responsible Party: | Nidek Co. LTD. |
| ClinicalTrials.gov Identifier: | NCT01663688 History of Changes |
| Other Study ID Numbers: | OCT RS-3000 |
| Study First Received: | July 12, 2012 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 19, 2013