Second Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
Completed
- Conditions
- Corneal Endothelial Cell Loss
- Interventions
- Device: Topcon Specular Microscope SP-1PDevice: Konan Specular Microscope CELLCHEK XL
- Registration Number
- NCT02427256
- Lead Sponsor
- Topcon Medical Systems, Inc.
- Brief Summary
The primary objective of this clinical study is to collect additional 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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 29-80 yrs Topcon Specular Microscope SP-1P - Non-Pathologic Adults age 29-80 yrs Konan Specular Microscope CELLCHEK XL - Pathologic Adults age 29-80 yrs Topcon Specular Microscope SP-1P - Non-Pathologic Adults age 18-28 yrs Konan Specular Microscope CELLCHEK XL - Pathologic Adults age 29-80 yrs Konan Specular Microscope CELLCHEK XL -
- Primary Outcome Measures
Name Time Method Coefficient of variation of endothelial cell area Single time point - 1 day Corneal endothelial cell % hexagonality Single time point - 1 day Central corneal thickness Single time point - 1 day Corneal endothelial cell density Single time point - 1 day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States