Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.
ClinicalTrials.gov Identifier:
NCT01663688
First received: July 12, 2012
Last updated: January 16, 2014
Last verified: January 2014

July 12, 2012
January 16, 2014
July 2012
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01663688 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Normal subject eyes

Ocular Physiology
Not Provided
Normative Data Collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
279
August 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01663688
OCT RS-3000
No
Nidek Co. LTD.
Nidek Co. LTD.
Not Provided
Principal Investigator: Robert N Weinreb, MD Hamilton Glaucoma Center, UC San Diego
Nidek Co. LTD.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP