Corneal Endothelial Cell Loss
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICESpecular Microscope Nidek CEM-530
Nidek CEM-530
DEVICESpecular Microscope Konan CELLCHEK XL
Konan CELLCHEK XL
Sponsors
Nidek Co. LTD.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Non-Pathologic: Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site,and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. * Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions: * History of post-op surgical trauma including bullous keratopathy * History of corneal transplant * Physical injury or trauma to the cornea * Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies * Keratoconus * Long term PMMA contact lens use (greater than 3 years)
Exclusion criteria
* Non-Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions: * History of post-op surgical trauma including bullous keratopathy * History of corneal transplant * Physical injury or trauma to the cornea * Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies * Keratoconus * Long term PMMA contact lens use (greater than 3 years) * Pathologic: History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device. Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) CEM-530 and KONAN CELLCHEK PLUS images in either eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Center Method Corneal Endothelial Cell Density | single time point - 1 day | — |
| Center Method Coefficient of Variation of Endothelial Cell Area | single time point - 1 day | Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed |
| Percentage Hexagonality | single time point - 1 day | Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 18-28 Years Old Non-pathologic 18-28 years old Non-pathologic Device: Nidek CEM-530 | 28 |
| 29-80 Years Old Non-pathologic 29-80 years old Non-pathologic Device: Nidek CEM-530 | 28 |
| 29-80 Years Old Pathological 29-80 years old pathological Device: Nidek CEM-530 | 23 |
| Total | 79 |
Baseline characteristics
| Characteristic | 29-80 Years Old Non-pathologic | 29-80 Years Old Pathological | 18-28 Years Old Non-pathologic | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 23 Participants | 28 Participants | 79 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 13.42 | 63.9 years STANDARD_DEVIATION 12.39 | 22.2 years STANDARD_DEVIATION 3.8 | 44.1 years STANDARD_DEVIATION 20.54 |
| Region of Enrollment United States | 28 participants | 23 participants | 28 participants | 79 participants |
| Sex: Female, Male Female | 19 Participants | 15 Participants | 13 Participants | 47 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 28 | 0 / 23 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 | 0 / 23 |
Outcome results
Primary
Center Method Coefficient of Variation of Endothelial Cell Area
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
Population: Not all participants indicated in the Participant Flow Module were analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 18-28 Years Old Non-pathologic | Center Method Coefficient of Variation of Endothelial Cell Area | 20.3 percent of Coefficient of variation | Standard Deviation 1.9 |
| 29-80 Years Old Non-pathologic | Center Method Coefficient of Variation of Endothelial Cell Area | 23.3 percent of Coefficient of variation | Standard Deviation 3.27 |
| 29-80 Years Old Pathological | Center Method Coefficient of Variation of Endothelial Cell Area | 23.0 percent of Coefficient of variation | Standard Deviation 4.11 |
Primary
Center Method Corneal Endothelial Cell Density
Time frame: single time point - 1 day
Population: Not all participants indicated in the Participant Flow Module were analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 18-28 Years Old Non-pathologic | Center Method Corneal Endothelial Cell Density | 3069.5 cells/mm2 | Standard Deviation 346.41 |
| 29-80 Years Old Non-pathologic | Center Method Corneal Endothelial Cell Density | 2678.6 cells/mm2 | Standard Deviation 391.33 |
| 29-80 Years Old Pathological | Center Method Corneal Endothelial Cell Density | 2514 cells/mm2 | Standard Deviation 351.02 |
Primary
Percentage Hexagonality
Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium
Time frame: single time point - 1 day
Population: Not all participants indicated in the Participant Flow Module were analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 18-28 Years Old Non-pathologic | Percentage Hexagonality | 63.0 Percentage hexagonality | Standard Deviation 6.33 |
| 29-80 Years Old Non-pathologic | Percentage Hexagonality | 57.1 Percentage hexagonality | Standard Deviation 6.66 |
| 29-80 Years Old Pathological | Percentage Hexagonality | 58.7 Percentage hexagonality | Standard Deviation 7.96 |