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Nidek RS3000 Comparative Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.
ClinicalTrials.gov Identifier:
NCT01384487
First received: June 27, 2011
Last updated: February 17, 2012
Last verified: February 2012
History of Changes

June 27, 2011
February 17, 2012
June 2011
November 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01384487 on ClinicalTrials.gov Archive Site
Any adverse events [ Time Frame: One Visit ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinic
  • Glaucoma
  • Retinal Disease
  • Corneal Disease
Not Provided
  • Normal Eyes
    Eyes without disease
  • Eyes with Glaucoma
  • Eyes with Retinal Disease
  • Eyes with Corneal Disease
    Including post keratorefractive surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01384487
Nidek RS3000-1
No
Nidek Co. LTD.
Nidek Co. LTD.
Not Provided
Principal Investigator: Robert Weinreb, M.D. UCSD, Hamilton Glaucoma Center
Nidek Co. LTD.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP