Clinical trial NCT02276638: Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality
Official title: Comparative Study of the Specular Microscopes for Center Point Method and Corner Point Method for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area and % Hexagonality.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Endothelial Cell Loss
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2014-10-28
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ophthalmology Practice

Brief summary: The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The secondary objective is to evaluate any adverse events found during the clinical study.

Detailed description: The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method.

Eligibility criteria: 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 can follow the instructions by the clinical staff at the clinical site,and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study.
* 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 can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions:

  * History of post-op surgical trauma including bullous keratopathy
  * History of corneal transplant
  * Physical injury or trauma to the cornea
  * Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
  * Keratoconus
  * Long term PMMA contact lens use (greater than 3 years)

Exclusion Criteria:

* Non-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 can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions:

  * History of post-op surgical trauma including bullous keratopathy
  * History of corneal transplant
  * Physical injury or trauma to the cornea
  * Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
  * Keratoconus
  * Long term PMMA contact lens use (greater than 3 years)
* Pathologic: History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device. Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) CEM-530 and KONAN CELLCHEK PLUS images in either eye.

Primary outcomes:
measure: Center Method Corneal Endothelial Cell Density
timeFrame: single time point - 1 day
measure: Center Method Coefficient of Variation of Endothelial Cell Area
timeFrame: single time point - 1 day
measure: Percentage Hexagonality
timeFrame: single time point - 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References: