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| Name | Class |
|---|---|
| Ohio State University | OTHER |
| R. P. Chiacchierini Consulting, LLC | INDUSTRY |
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The purpose of this study is to evaluate the precision and agreement of the study device, a specular microscope, in comparison to a currently commercially available specular microscope in establishing substantial equivalence of the two devices in clinical use for diagnostic purposes of the human cornea.
The observational clinical investigation is intended to measure agreement between two diagnostic instruments of the eye's corneal endothelium. The study device is the EM-3000 specular microscope and the control device is the NonCon Robo Pachy (F&A) (CellChek XL) specular microscope. Both instruments measure corneal endothelial cell layer parameters including cell density, coefficient of variation, percent hexagonality, and central thickness.
The primary variable is the measurement of agreement between the two instruments for the four parameters described. The secondary variables include repeatability (intra-investigator) and reproducibility both inter-investigator, and inter-instrument.
Additionally, measurements of agreement will be made on the EM-3000 using automated analysis with and without touch-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Observational group exposure to three test devices and one comparative device. The test Konan Non-con Robo Pachy F&A Specular Microscope. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Intervention is observational to two different diagnostic devices for which comparative readings of the corneal endothelium are being measured; the test device- the EM-3000 Specular Microscope against the Konan Robo-pachy F&A Specular Microscope. |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between EM-3000 and NonCon Robo Pachy F&A (CellChek XL) | For Agreement between the two instruments, outcome measures include endothelial cell density (/mm2), coefficient of variation between the two instruments (SD x CD x 10-6, and percent hexagonality of cells in the measured visible field of view between the two instruments. | 1 day visit per subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate Repeatability and Reproducibility between the EM-3000 and NonCon Robo Pachy F&A (CellChek XL) Specular Microscopes | To investigate repeatability (intra-investigator) in the EM-3000 specular microscope in the four outcome measures of the corneal endothelium as well as corneal thickness. To investigate reproducibility (inter-investigator/instrument) of the EM-3000 specular microscope in the four outcome measures of the corneal endothelium and corneal thickness. |
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Inclusion Criteria:
Non-pathologic younger eyes (18-50 yrs) Non-pathologic older eyes (51-80 yrs) Pathologic adult eyes (29-80)
Exclusion Criteria
Seriously ill or unconscious subject, mentally ill person, mentally handicapped person, person who is unable to read or write.
History of corneal transplant
Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
Guttata
History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device
Long term PMMA contact lens use longer than 5 years
-Pathologic subjects
Keratoconus
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The study plan calls for 75 subjects divided into three sub-groups, young healthy (18-50 yrs), older healthy (51-80 yrs), and pathologic adults (29-80 years).
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Bailey, OD | Professor, College of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| 1 day visit per subject. |