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Completed

NCT Number: NCT02050880

OCT Agreement and Crossed Precision Study

The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

WCCT Global Opthalmology Research Center

Santa Ana, California, 92705, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

NORMAL EYES

  • Subjects who do not have pathology in both eyes

Inclusion criteria

GLAUCOMA

  • Subjects who have a glaucoma diagnosis

Inclusion criteria

RETINAL

  • Subjects who have a retinal diagnosis including but not limited to:
  • Diabetic macular edema
  • Dry age related macular degeneration
  • Wet age related macular degeneration
  • Cystoid macular edema
  • Epiretinal membrane
  • Macular hole

Inclusion criteria

CORNEAL

  • Subjects who has one of these diagnosis:
  • Post status LASIK surgery
  • Keratoconus
  • Other corneal dystrophies or degenerations.

Exclusion criteria

ALL EYES

  • Subjects who have any of the following conditions
  • Diabetes mellitus (DM) and/or diabetic retinopathy
  • Uncontrolled Hypertension (HT)
  • Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
  • Cardiac, hepatic, renal and hematologic diseases
  • A current condition requiring systemic administration of steroid
  • A history of, or currently receiving, anticancer therapy
  • Epileptic seizures which are optically induced
  • Dementia
  • Subjects who have other life threatening and debilitating systemic diseases

Note: Additional criteria may apply

Treatment and study plan

Primary outcomes

  1. Retinal thickness

    Time frame: Approximately four hours

    Time frame is the maximum duration of hospital stay

  2. Optic Disc Analysis

    Time frame: Approximately four hours

    Time frame is the maximum duration of hospital stay

  3. Corneal Thickness

    Time frame: Approximately four hours

    Time frame is the maximum duration of hospital stay

Sponsors and collaborators

Lead sponsor

Nidek Co. LTD.

Industry

Registry information

Official study title

Crossed Precision Design Study of the Nidek Optical Coherence Tomography RS-3000, RS-3000 Lite and RS-3000 Advance for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, and Pachymetry

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 31, 2014
Registry last updated
Sep 29, 2014

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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