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

Tomey

Status: Completed

Conditions: Cornea

Treatments: Other: Observational

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02293122

602-a01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

75 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Observational