Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality
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| ClinicalTrials.gov Identifier: NCT02276638 |
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Recruitment Status :
Completed
First Posted : October 28, 2014
Results First Posted : March 11, 2019
Last Update Posted : March 20, 2019
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Sponsor:
Nidek Co. LTD.
Information provided by (Responsible Party):
Nidek Co. LTD.
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| Study Type | Observational |
|---|---|
| Study Design | Observational Model: Cohort; Time Perspective: Prospective |
| Condition |
Corneal Endothelial Cell Loss |
| Interventions |
Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL |
| Enrollment | 79 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | 18-28 Years Old Non-pathologic | 29-80 Years Old Non-pathologic | 29-80 Years Old Pathological |
|---|---|---|---|
 Arm/Group Description |
18-28 years old Non-pathologic Device: Nidek CEM-530 | 29-80 years old Non-pathologic Device: Nidek CEM-530 | 29-80 years old pathological Device: Nidek CEM-530 |
| Period Title: Overall Study | |||
| Started | 28 | 28 | 23 |
| Completed | 28 | 28 | 23 |
| Not Completed | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 18-28 Years Old Non-pathologic | 29-80 Years Old Non-pathologic | 29-80 Years Old Pathological | Total | |
|---|---|---|---|---|---|
|
Arm/Group Description |
18-28 years old Non-pathologic Device: Nidek CEM-530 | 29-80 years old Non-pathologic Device: Nidek CEM-530 | 29-80 years old pathological Device: Nidek CEM-530 | Total of all reporting groups | |
| Overall Number of Baseline Participants | 28 | 28 | 23 | 79 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 28 participants | 28 participants | 23 participants | 79 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
28 100.0%
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28 100.0%
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23 100.0%
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79 100.0%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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|
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 28 participants | 28 participants | 23 participants | 79 participants | |
| 22.2 (3.8) | 53 (13.42) | 63.9 (12.39) | 44.1 (20.54) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 28 participants | 28 participants | 23 participants | 79 participants | |
| Female |
13 46.4%
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19 67.9%
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15 65.2%
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47 59.5%
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| Male |
15 53.6%
|
9 32.1%
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8 34.8%
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32 40.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 28 participants | 28 participants | 23 participants | 79 participants |
| 28 | 28 | 23 | 79 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Head, Regulatory Affairs |
| Organization: | Nidek |
| Phone: | (800) 223-9044 |
| EMail: | support@nidek.com |
| Responsible Party: | Nidek Co. LTD. |
| ClinicalTrials.gov Identifier: | NCT02276638 |
| Other Study ID Numbers: |
CEM-530-US-0002 |
| First Submitted: | October 14, 2014 |
| First Posted: | October 28, 2014 |
| Results First Submitted: | March 25, 2016 |
| Results First Posted: | March 11, 2019 |
| Last Update Posted: | March 20, 2019 |