Andover Eye Associates
Andover, Massachusetts, 01810, United States
NCT Number: NCT02138266
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.
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Notify Me18 year–80 year
All sexes
Observational
Andover, Massachusetts, 01810, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Non-Pathologic Young Adults (18-28 years old) and Non-Pathologic Adults (29-80 years old):
Inclusion criteria
-Pathologic Adults (29-80 years old)
Exclusion criteria
-Non-Pathologic Young Adults (18-28 years old) and Non Pathologic Adults (29-80 years old)
Exclusion criteria
-Pathologic Adults (29-80 years old):
Time frame: Single time point - 1 day
Time frame: Single time point - 1 day
Time frame: Single time point - 1 day
Time frame: Single time point - 1 day
Topcon Medical Systems, Inc.
Industry
Comparative Study of the Topcon Specular Microscope SP-1P and the Konan Specular Microscope CELLCHEK XL (Predicate Device) for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area, % Hexagonality, Central Corneal Thickness
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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