Clinical trial NCT02138266: Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
Official title: Comparative Study of the Topcon Specular Microscope SP-1P and the Konan Specular Microscope CELLCHEK XL (Predicate Device) for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area, ％ Hexagonality, Central Corneal Thickness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Endothelial Cell Loss
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 65
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 Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility criteria: Inclusion Criteria -Non-Pathologic Young Adults (18-28 years old) and Non-Pathologic Adults (29-80 years old):

* 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.

Inclusion Criteria -Pathologic Adults (29-80 years old)

* 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 Pseudophakic or Aphakic bullous keratopathy;
  * History of corneal transplant;
  * Physical injury or trauma to the cornea;
  * Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophies)
  * Keratoconus;
  * Long term PMMA contact lens use (greater than 3 years).

Exclusion Criteria -Non-Pathologic Young Adults (18-28 years old) and Non Pathologic Adults (29-80 years old)

* History of corneal transplant;
* Long term Fuch's dystrophy (and other corneal endothelial dystrophies);
* Keratoconus;
* Guttata;
* Diabetes mellitus type I or type II;
* 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;
* All contact lens wearers;
* Fixation problems which may prevent obtaining good quality SP-1P and CELLCHEK PLUS in either eye.

Exclusion Criteria -Pathologic Adults (29-80 years old):

* Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) SP-1P and KONAN CELLCHEK PLUS images in either eye.

Primary outcomes:
measure: Corneal endothelial cell density
timeFrame: Single time point - 1 day
measure: Coefficient of variation of endothelial cell area
timeFrame: Single time point - 1 day
measure: Corneal endothelial cell % hexagonality
timeFrame: Single time point - 1 day
measure: Central corneal thickness
timeFrame: Single time point - 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References: