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OpenTrials
Completed

NCT Number: NCT01729975

Comparative Study of Specular Microscope for Cell Density, Coefficient of Variation, Hexagonality and Corneal Thickness

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to evaluate any adverse events found during the clinical study.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Non-Pathologic: Male or female subjects from 18 to 80 years old 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.
  • Pathologic: Male and female subjects from 29 to 80 years old 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 and subjects who have any of the following conditions:
  • History of Post-op surgical trauma including, Psudophakic or Aphakic blous keratopathy or glaucoma surgery
  • History of corneal transplant
  • Physical injury or trauma to the cornea
  • Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophy)
  • Keratoconus
  • Long term PMMA contact lens use

Exclusion criteria

  • Non-Pathologic subjects who have the following conditions:
  • Long term Diabetes
  • Dementia
  • Subjects who have other life threatening and/or debilitating systemic diseases
  • History of corneal transplant
  • Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
  • Keratoconus
  • Guttata
  • Diabetic retinopathy
  • History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
  • All contact lens wearers
  • Pathologic subjects who have Dementia or who have other life threatening and/or debilitating systemic diseases

Treatment and study plan

Primary outcomes

  1. Corneal and Endothelial Cell Measurements

    Time frame: single time point - 1 day

    Substantial equivalence to a predicate device with respect to corneal and endothelial cell measurements

Sponsors and collaborators

Lead sponsor

Nidek Co. LTD.

Industry

Registry information

Official study title

Comparative Study of Specular Microscopes for the Measurement of Endothelial Cell Densities, Coefficient of Variation of Endothelial Cell Area, %Hexagonality, and Central Corneal Thickness

Important dates

Study start
2012
Primary completion
2012
First posted
Nov 21, 2012
Registry last updated
Nov 21, 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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