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Completed

NCT Number: NCT02293122

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

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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Key information

Conditions

Cornea Corneal Diseases Eye Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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 :
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Agreement Between EM-3000 and NonCon Robo Pachy F&A (CellChek XL)

    Time frame: 1 day visit per subject.

    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.

Secondary outcomes

  1. Investigate Repeatability and Reproducibility between the EM-3000 and NonCon Robo Pachy F&A (CellChek XL) Specular Microscopes

    Time frame: 1 day visit per subject.

    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.

Sponsors and collaborators

Lead sponsor

Tomey Corporation

Industry

Collaborators

  • Ohio State University
  • R. P. Chiacchierini Consulting, LLC

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2014
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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