Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02977793

Enrollment

Registered

2016-11-30

Start date

2016-10-31

Completion date

2017-01-31

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal and Endothelial Cell Measurements

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.

Interventions

DEVICETomey EM-4000 Specular Microscope

DEVICEKonan CellChek XL Specular Microscope

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Endothelial cell density measurements	1 day
Coefficient of variation of endothelial cell area	1 day
% Hexagonality	1 day
Central Corneal Thickness	1 day

Secondary

Measure	Time frame
Adverse Events	1 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026