Nidek RS3000 Comparative Study

• Sponsor: Nidek Co. LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01384487
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 17.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Retinal Disease; Corneal Disease

Study Design

• Study Type: Observational
• Actual Enrollment: 89 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: 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.
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Normal Eyes Eyes without disease
Eyes with Glaucoma
Eyes with Retinal Disease
Eyes with Corneal Disease Including post keratorefractive surgery

Outcome Measures

Primary Outcome Measures

1. Total Retinal Thickness [One Visit]

2. Inner Retinal Thickness [One Visit]

3. Outer Retinal Thickness [One Visit]

4. RNFL Thickness [One Visit]

5. Optic Disc Analysis [One Visit]

6. G Chart [One Visit]

7. Anterior Chamber Angle Image [One Visit]

8. SLO Image [One Visit]

9. Pachymetry [One Visit]

Secondary Outcome Measures

1. Any adverse events [One Visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamilton Glaucoma Center	La Jolla	California	United States	92093-0946

Sponsors and Collaborators

• Nidek Co. LTD.

Investigators

• Principal Investigator: Robert Weinreb, M.D., UCSD, Hamilton Glaucoma Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nidek Co. LTD.
• ClinicalTrials.gov Identifier: NCT01384487
• Other Study ID Numbers: Nidek RS3000-1
• First Posted: Jun 29, 2011
• Last Update Posted: Feb 20, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Nidek Co. LTD.: Viewing and axial cross sectional imaging of ocular; structures, including the anterior chamber
• Additional relevant MeSH terms: Retinal Diseases; Corneal Diseases

Study Results

No Results Posted as of Feb 20, 2012