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Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality

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ClinicalTrials.gov Identifier: NCT02276638
Recruitment Status : Completed
First Posted : October 28, 2014
Results First Posted : March 11, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.

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
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
Hide 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
Arm/Group Title 18-28 Years Old Non-pathologic 29-80 Years Old Non-pathologic 29-80 Years Old Pathological Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 23 participants 79 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
28
 100.0%
23
 100.0%
79
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 23 participants 79 participants
Female
13
  46.4%
19
  67.9%
15
  65.2%
47
  59.5%
Male
15
  53.6%
9
  32.1%
8
  34.8%
32
  40.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 28 participants 23 participants 79 participants
28 28 23 79
1.Primary Outcome
Title Center Method Corneal Endothelial Cell Density
Hide Description [Not Specified]
Time Frame single time point - 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants indicated in the Participant Flow Module were analysed.
Arm/Group Title 18-28 Years Old Non-pathologic 29-80 Years Old Non-pathologic 29-80 Years Old Pathological
Hide 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
Overall Number of Participants Analyzed 28 27 19
Mean (Standard Deviation)
Unit of Measure: cells/mm2
3069.5  (346.41) 2678.6  (391.33) 2514  (351.02)
2.Primary Outcome
Title Center Method Coefficient of Variation of Endothelial Cell Area
Hide Description Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed
Time Frame single time point - 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants indicated in the Participant Flow Module were analysed.
Arm/Group Title 18-28 Years Old Non-pathologic 29-80 Years Old Non-pathologic 29-80 Years Old Pathological
Hide 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
Overall Number of Participants Analyzed 28 27 19
Mean (Standard Deviation)
Unit of Measure: percent of Coefficient of variation
20.3  (1.90) 23.3  (3.27) 23.0  (4.11)
3.Primary Outcome
Title Percentage Hexagonality
Hide Description Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium
Time Frame single time point - 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants indicated in the Participant Flow Module were analysed.
Arm/Group Title 18-28 Years Old Non-pathologic 29-80 Years Old Non-pathologic 29-80 Years Old Pathological
Hide 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
Overall Number of Participants Analyzed 28 27 19
Mean (Standard Deviation)
Unit of Measure: Percentage hexagonality
63.0  (6.33) 57.1  (6.66) 58.7  (7.96)
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 18-28 Years Old Non-pathologic 29-9- Years Old Non-pathologic 29-80 Years Old Pathological
Hide Arm/Group Description

Device: Nidek CEM-530 Device: Konan Specular Microscope CELLCHEK XL

Specular Microscope: Nidek CEM-530

Specular Microscope: Konan CELLCHECK XL

Device: Nidek CEM-530 Device: Konan Specular Microscope CELLCHEK XL

Specular Microscope: Nidek CEM-530

Specular Microscope: Konan CELLCHECK XL

Device: Nidek CEM-530 Device: Konan Specular Microscope CELLCHEK XL

Specular Microscope: Nidek CEM-530

Specular Microscope: Konan CELLCHECK XL

All-Cause Mortality
18-28 Years Old Non-pathologic 29-9- Years Old Non-pathologic 29-80 Years Old Pathological
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
18-28 Years Old Non-pathologic 29-9- Years Old Non-pathologic 29-80 Years Old Pathological
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%)   0/23 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
18-28 Years Old Non-pathologic 29-9- Years Old Non-pathologic 29-80 Years Old Pathological
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%)   0/23 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head, Regulatory Affairs
Organization: Nidek
Phone: (800) 223-9044
EMail: support@nidek.com
Layout table for additonal information
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