To Investigate Agreement Between the EM-3000 and the Predicate Device Noncon Robo Pachy (F&A) (CellChek XL)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cornea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Observational group exposure to three test devices and one comparative device. The test Konan Non-con Robo Pachy F\&A Specular Microscope.

Observational

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Eyes with one of the following corneal conditions:

Non-pathologic younger eyes (18-50 yrs) Non-pathologic older eyes (51-80 yrs) Pathologic adult eyes (29-80)

Exclusion Criteria

1. Seriously ill or unconscious subject, mentally ill person, mentally handicapped person, person who is unable to read or write.

* Non-Pathologic subjects who have the following conditions :
2. History of corneal transplant
3. Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
4. Guttata
5. History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device
6. Long term PMMA contact lens use longer than 5 years

-Pathologic subjects
7. Keratoconus

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes