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Completed

NCT Number: NCT01384487

Nidek RS3000 Comparative Study

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.

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Key information

Conditions

Glaucoma Corneal Disease Corneal Diseases Eye Diseases Ocular Hypertension Retinal Disease Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Glaucoma Center

La Jolla, California, 92093-0946, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Dementia
  • Subjects who have other life threatening and debilitating systemic diseases

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

Treatment and study plan

Primary outcomes

  1. Total Retinal Thickness

    Time frame: One Visit

  2. Inner Retinal Thickness

    Time frame: One Visit

  3. Outer Retinal Thickness

    Time frame: One Visit

  4. RNFL Thickness

    Time frame: One Visit

  5. Optic Disc Analysis

    Time frame: One Visit

  6. G Chart

    Time frame: One Visit

  7. Anterior Chamber Angle Image

    Time frame: One Visit

  8. SLO Image

    Time frame: One Visit

  9. Pachymetry

    Time frame: One Visit

Secondary outcomes

  1. Any adverse events

    Time frame: One Visit

Sponsors and collaborators

Lead sponsor

Nidek Co. LTD.

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 29, 2011
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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