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

Completed

• Conditions: Corneal and Endothelial Cell Measurements
• Interventions: Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope

• Registration Number: NCT02977793
• Lead Sponsor: Tomey Corporation

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-30
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-pathologic adults	Konan CellChek XL Specular Microscope	29-80 years old
Pathologic adults	Tomey EM-4000 Specular Microscope	29-80 years old
Non-pathologic young adults	Tomey EM-4000 Specular Microscope	18-28 years old
Non-pathologic adults	Tomey EM-4000 Specular Microscope	29-80 years old
Pathologic adults	Konan CellChek XL Specular Microscope	29-80 years old
Non-pathologic young adults	Konan CellChek XL Specular Microscope	18-28 years old

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 day