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

Nidek

Status: Completed

Conditions: Corneal and Endothelial Cell Measurements

Study type: Observational

Funder types: Industry

Identifiers

NCT01729975

CEM-530-US-001

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 3 patient groups

18-28 years old Non-pathologic

29-80 years old Non-Pathologic

29-80 years old pathologic corneal disease