Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

Completed

• Conditions: Corneal Endothelial Cell Loss
• Interventions: Device: Topcon Specular Microscope SP-1P; Device: Konan Specular Microscope CELLCHEK XL

• Registration Number: NCT02138266
• Lead Sponsor: Topcon Medical Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-03
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Study Completion: 2014-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Pathologic Adults age 18-28 yrs	Topcon Specular Microscope SP-1P	Non-Pathologic Adults age 18-28 yrs
Non-Pathologic Adults age 18-28 yrs	Konan Specular Microscope CELLCHEK XL	Non-Pathologic Adults age 18-28 yrs
Non-Pathologic Adults age 29-80 yrs	Konan Specular Microscope CELLCHEK XL	Non-Pathologic Adults age 29-80 yrs
Non-Pathologic Adults age 29-80 yrs	Topcon Specular Microscope SP-1P	Non-Pathologic Adults age 29-80 yrs
Pathologic Adults age 29-80 yrs	Topcon Specular Microscope SP-1P	Pathologic Adults age 29-80 yrs
Pathologic Adults age 29-80 yrs	Konan Specular Microscope CELLCHEK XL	Pathologic Adults age 29-80 yrs

Primary Outcome Measures

Name	Time	Method
Central corneal thickness	Single time point - 1 day
Coefficient of variation of endothelial cell area	Single time point - 1 day
Corneal endothelial cell density	Single time point - 1 day
Corneal endothelial cell % hexagonality	Single time point - 1 day

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States