Trial Outcomes & Findings for Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality (NCT NCT02276638)

Results Overview

Recruitment status

COMPLETED

Target enrollment

79 participants

Primary outcome timeframe

single time point - 1 day

Results posted on

2019-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	18-28 Years Old Non-pathologic 18-28 years old Non-pathologic Device: Nidek CEM-530	29-80 Years Old Non-pathologic 29-80 years old Non-pathologic Device: Nidek CEM-530	29-80 Years Old Pathological 29-80 years old pathological Device: Nidek CEM-530
Overall Study STARTED	28	28	23
Overall Study COMPLETED	28	28	23
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18-28 Years Old Non-pathologic n=28 Participants 18-28 years old Non-pathologic Device: Nidek CEM-530	29-80 Years Old Non-pathologic n=28 Participants 29-80 years old Non-pathologic Device: Nidek CEM-530	29-80 Years Old Pathological n=23 Participants 29-80 years old pathological Device: Nidek CEM-530	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	28 Participants n=7 Participants	23 Participants n=5 Participants	79 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	22.2 years STANDARD_DEVIATION 3.8 • n=5 Participants	53 years STANDARD_DEVIATION 13.42 • n=7 Participants	63.9 years STANDARD_DEVIATION 12.39 • n=5 Participants	44.1 years STANDARD_DEVIATION 20.54 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	19 Participants n=7 Participants	15 Participants n=5 Participants	47 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants
Region of Enrollment United States	28 participants n=5 Participants	28 participants n=7 Participants	23 participants n=5 Participants	79 participants n=4 Participants

PRIMARY outcome

Timeframe: single time point - 1 day

Population: Not all participants indicated in the Participant Flow Module were analysed.

Outcome measures

Outcome measures
Measure	18-28 Years Old Non-pathologic n=28 Participants 18-28 years old Non-pathologic Device: Nidek CEM-530	29-80 Years Old Non-pathologic n=27 Participants 29-80 years old Non-pathologic Device: Nidek CEM-530	29-80 Years Old Pathological n=19 Participants 29-80 years old pathological Device: Nidek CEM-530
Center Method Corneal Endothelial Cell Density	3069.5 cells/mm2 Standard Deviation 346.41	2678.6 cells/mm2 Standard Deviation 391.33	2514 cells/mm2 Standard Deviation 351.02

PRIMARY outcome

Timeframe: single time point - 1 day

Population: Not all participants indicated in the Participant Flow Module were analysed.

Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed

Outcome measures

Outcome measures
Measure	18-28 Years Old Non-pathologic n=28 Participants 18-28 years old Non-pathologic Device: Nidek CEM-530	29-80 Years Old Non-pathologic n=27 Participants 29-80 years old Non-pathologic Device: Nidek CEM-530	29-80 Years Old Pathological n=19 Participants 29-80 years old pathological Device: Nidek CEM-530
Center Method Coefficient of Variation of Endothelial Cell Area	20.3 percent of Coefficient of variation Standard Deviation 1.90	23.3 percent of Coefficient of variation Standard Deviation 3.27	23.0 percent of Coefficient of variation Standard Deviation 4.11

PRIMARY outcome

Timeframe: single time point - 1 day

Population: Not all participants indicated in the Participant Flow Module were analysed.

Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium

Outcome measures

Outcome measures
Measure	18-28 Years Old Non-pathologic n=28 Participants 18-28 years old Non-pathologic Device: Nidek CEM-530	29-80 Years Old Non-pathologic n=27 Participants 29-80 years old Non-pathologic Device: Nidek CEM-530	29-80 Years Old Pathological n=19 Participants 29-80 years old pathological Device: Nidek CEM-530
Percentage Hexagonality	63.0 Percentage hexagonality Standard Deviation 6.33	57.1 Percentage hexagonality Standard Deviation 6.66	58.7 Percentage hexagonality Standard Deviation 7.96

Adverse Events

18-28 Years Old Non-pathologic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

29-9- Years Old Non-pathologic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

29-80 Years Old Pathological

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Head, Regulatory Affairs

Nidek

Phone: (800) 223-9044

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place