Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL

NCT02977793 | Completed

• 1 other identifier: TOMEY-EM4000-US-001
• Study Type: observational
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.

Conditions

Corneal and Endothelial Cell Measurements

Outcome Measures

Primary Outcomes (4)

• Endothelial cell density measurements

  1 day

• Coefficient of variation of endothelial cell area

  1 day

• % Hexagonality

  1 day

• Central Corneal Thickness

  1 day

Secondary Outcomes (1)

• Adverse Events

  1 day

Study Arms (3)

Non-pathologic young adults

18-28 years old

Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope

Non-pathologic adults

29-80 years old

Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope

Pathologic adults

29-80 years old

Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope

Interventions

Tomey EM-4000 Specular Microscope DEVICE

Non-pathologic adults; Non-pathologic young adults; Pathologic adults

Konan CellChek XL Specular Microscope DEVICE

Non-pathologic adults; Non-pathologic young adults; Pathologic adults

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects recruited can be male or female, of any race or ethnicity, ages 18-80 years of age at Visit 1. All subjects enrolled must meet all the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
• Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
• Subjects who agree to participate in the study.
• Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
• Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
• Subjects who agree to participate in the study;
• At least one eye with any of the following conditions:
• History of post-op surgical trauma including pseudophakic or aphakic bullous keratopathy
• History of corneal transplant
• Physical injury or trauma to the cornea
• Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
• Keratoconus
• Long-term polymethyl methacrylate (PMMA) contact lens use (greater than 3 years).

You may not qualify if:

• History of post-op surgical trauma including bullous keratopathy;
• History of corneal transplant;
• Evidence of physical injury or trauma to the cornea;
• Fuch's dystrophy, Guttata or other corneal endothelial dystrophies;
• Keratoconus;
• Long-term PMMA contact lens use (greater than 3 years);
• History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
• Fixation problems which may prevent obtaining good Tomey EM-4000 and Konan CellChek XL images in either eye.
• History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
• Fixation problems which may prevent obtaining at least poor quality Tomey EM-4000 and Konan CellChek XL images in either eye.

Sponsors & Collaborators

• Tomey Corporation: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: November 30, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share