Nidek RS3000 Comparative Study
This study has been completed.
Information provided by (Responsible Party):
Nidek Co. LTD.
First received: June 27, 2011
Last updated: February 17, 2012
Last verified: February 2012
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.
||Observational Model: Case Control
Time Perspective: Prospective
||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.
Primary Outcome Measures:
- Total Retinal Thickness [ Time Frame: One Visit ] [ Designated as safety issue: No ]
- Inner Retinal Thickness [ Time Frame: One Visit ] [ Designated as safety issue: No ]
- Outer Retinal Thickness [ Time Frame: One Visit ] [ Designated as safety issue: No ]
- RNFL Thickness [ Time Frame: One Visit ] [ Designated as safety issue: No ]
- Optic Disc Analysis [ Time Frame: One Visit ] [ Designated as safety issue: No ]
- G Chart [ Time Frame: One Visit ] [ Designated as safety issue: No ]
- Anterior Chamber Angle Image [ Time Frame: One Visit ] [ Designated as safety issue: No ]
- SLO Image [ Time Frame: One Visit ] [ Designated as safety issue: No ]
- Pachymetry [ Time Frame: One Visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Any adverse events [ Time Frame: One Visit ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2011 (Final data collection date for primary outcome measure)
Eyes without disease
Eyes with Glaucoma
Eyes with Retinal Disease
Eyes with Corneal Disease
Including post keratorefractive surgery
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
- Subjects who have other life threatening and debilitating systemic diseases
NOTE: Additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384487
|Hamilton Glaucoma Center
|La Jolla, California, United States, 92093-0946 |
Nidek Co. LTD.
||Robert Weinreb, M.D.
||UCSD, Hamilton Glaucoma Center
No publications provided
||Nidek Co. LTD.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 27, 2011
||February 17, 2012
||United States: Institutional Review Board
Keywords provided by Nidek Co. LTD.:
Viewing and axial cross sectional imaging of ocular
structures, including the anterior chamber
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 11, 2014