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.

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Retinal Disease; Corneal Disease

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093-0946
      • Hamilton Glaucoma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

1. Subjects of legal age and who have full legal capacity to volunteer on the date the informed consent is signed.
2. Subjects who follow the instructions by Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.
3. Subjects who sign an informed consent form to participate in the clinical study.
4. Subjects who agree to take the qualifying examination and RS-3000 and RTVue data acquisition.

Exclusion Criteria:

1. Diabetes mellitus (DM) and/or diabetic retinopathy
2. Hypertension (HT)
3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
4. Cardiac, hepatic, renal and hematologic diseases
5. Current systemic administration of steroid
6. History of anticancer agent etc.
7. Optically-stimulated epileptic seizure
8. Dementia
9. Subjects who have other life threatening and debilitating systemic diseases

NOTE: Additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Normal Eyes; Eyes without disease
Eyes with Glaucoma
Eyes with Retinal Disease
Eyes with Corneal Disease; Including post keratorefractive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Any adverse events	One Visit

Collaborators and Investigators

• Sponsor: Nidek Co. LTD.
• Investigators: Principal Investigator: Robert Weinreb, M.D., UCSD, Hamilton Glaucoma Center

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: June 28, 2011
• First Posted (Estimate): June 29, 2011

Study Record Updates

• Last Update Posted (Estimate): February 20, 2012
• Last Update Submitted That Met QC Criteria: February 17, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Viewing and axial cross sectional imaging of ocular; structures, including the anterior chamber
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Corneal Diseases
• Other Study ID Numbers: Nidek RS3000-1