Nidek RS3000 Comparative Study
Comparative Study of the Nidek Optical Coherence Tomography RS-3000 and the RTVue OCT Predicate Device for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, Pachymetry, Anterior Chamber Imaging and SLO Imaging.
1 other identifier
observational
89
1 country
1
Brief Summary
The primary objective of this clinical study is to compare the Nidek RS-3000 Optical Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to evaluate any adverse events found during the clinical study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2011
Shorter than P25 for all trials
1 active site
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
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFebruary 20, 2012
February 1, 2012
5 months
June 27, 2011
February 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Total Retinal Thickness
One Visit
Inner Retinal Thickness
One Visit
Outer Retinal Thickness
One Visit
RNFL Thickness
One Visit
Optic Disc Analysis
One Visit
G Chart
One Visit
Anterior Chamber Angle Image
One Visit
SLO Image
One Visit
Pachymetry
One Visit
Secondary Outcomes (1)
Any adverse events
One Visit
Study Arms (4)
Normal Eyes
Eyes without disease
Eyes with Glaucoma
Eyes with Retinal Disease
Eyes with Corneal Disease
Including post keratorefractive surgery
Eligibility Criteria
Primary care clinic
You may qualify if:
- Subjects of legal age and who have full legal capacity to volunteer on the date the informed consent is signed.
- Subjects who follow the instructions by Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.
- Subjects who sign an informed consent form to participate in the clinical study.
- Subjects who agree to take the qualifying examination and RS-3000 and RTVue data acquisition.
You may not qualify if:
- Diabetes mellitus (DM) and/or diabetic retinopathy
- Hypertension (HT)
- Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
- Cardiac, hepatic, renal and hematologic diseases
- Current systemic administration of steroid
- History of anticancer agent etc.
- Optically-stimulated epileptic seizure
- Dementia
- Subjects who have other life threatening and debilitating systemic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nidek Co. LTD.lead
Study Sites (1)
Hamilton Glaucoma Center
La Jolla, California, 92093-0946, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Weinreb, M.D.
UCSD, Hamilton Glaucoma Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2011
First Posted
June 29, 2011
Study Start
June 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
February 20, 2012
Record last verified: 2012-02