At a glance
ClinicalIndex Comparison RecordN/ACompleted· 79 enrolled
Drug / intervention
Specular Microscope Nidek CEM-530 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparative Study of the Specular Microscopes for Center Point Method and Corner Point Method for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area and % Hexagonality.
In Brief
An observational study evaluating Specular Microscope Nidek CEM-530 and Specular Microscope Konan CELLCHEK XL for Corneal Endothelial Cell Loss. Completed, enrolled 79 participants across 1 site.
Detailed Summary
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The secondary objective is to evaluate any adverse events found during the clinical study.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCorneal Endothelial Cell Loss
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
Primary CompletionOct 2014
First PostedOct 2014
TodayJul 2026
First PostedOct 28, 2014
Enrollment StartSep 1, 2014
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.7 years ago
Interventions
Specular Microscope Nidek CEM-530device
Nidek CEM-530
Specular Microscope Konan CELLCHEK XLdevice
Konan CELLCHEK XL