Clinical trial NCT02977793: Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL
Official title: Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL for the Measurements of Endothelial Cell Density, Coefficient of Variation of Endothelial Cell Area, % Hexagonality, Central Corneal Thickness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal and Endothelial Cell Measurements
Lead sponsor: Tomey Corporation
Sponsor class: INDUSTRY
First posted: 2016-11-30
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects recruited can be male or female, of any race or ethnicity, ages 18-80 years of age at Visit 1. All subjects enrolled must meet all the inclusion criteria and none of the exclusion criteria.

Brief summary: The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.

Detailed description: The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium by capturing an image of corneal endothelium tissues. without making contact, analyzing the captured image, and calculating data such as cell density.

Eligibility criteria: Inclusion Criteria-Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old)

1. 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;
2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
3. Subjects who agree to participate in the study.

Inclusion Criteria -Pathologic adults (29-80 years old):

1. 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;
2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
3. Subjects who agree to participate in the study;
4. At least one eye with any of the following conditions:

   1. History of post-op surgical trauma including pseudophakic or aphakic bullous keratopathy
   2. History of corneal transplant
   3. Physical injury or trauma to the cornea
   4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
   5. Keratoconus
   6. Long-term polymethyl methacrylate (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)

1. History of post-op surgical trauma including bullous keratopathy;
2. History of corneal transplant;
3. Evidence of physical injury or trauma to the cornea;
4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies;
5. Keratoconus;
6. Long-term PMMA contact lens use (greater than 3 years);
7. 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;
8. Fixation problems which may prevent obtaining good Tomey EM-4000 and Konan CellChek XL images in either eye.

Exclusion Criteria - Pathologic adults (29-80 years old)

1. 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;
2. Fixation problems which may prevent obtaining at least poor quality Tomey EM-4000 and Konan CellChek XL images in either eye.

Primary outcomes:
measure: Endothelial cell density measurements
timeFrame: 1 day
measure: Coefficient of variation of endothelial cell area
timeFrame: 1 day
measure: % Hexagonality
timeFrame: 1 day
measure: Central Corneal Thickness
timeFrame: 1 day
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References: