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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01384487

Enrollment

Registered

2011-06-29

Start date

2011-06-30

Completion date

2011-11-30

Last updated

2012-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Disease, Glaucoma, Retinal Disease

Keywords

Viewing and axial cross sectional imaging of ocular, structures, including the anterior chamber

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Pachymetry	One Visit
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

Secondary

Measure	Time frame
Any adverse events	One Visit

Countries

United States

Outcome results