An observational study in Cornea, sponsored by Tomey Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Tomey Corporation · Observational
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.
219 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.
This study's enrollment of 75 is below the median of 100 across 73 observational studies indexed under Corneal Diseases.
Browse Corneal Diseases studies →Tomey Corporation is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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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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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.
Long term PMMA contact lens use longer than 5 years
-Pathologic subjects
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Observational group exposure to three test devices and one comparative device. The test Konan Non-con Robo Pachy F\&A Specular Microscope.
Other: Observational
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.
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.
Time frame: 1 day visit per subject.
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.
Time frame: 1 day visit per subject.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Tomey Corporation