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

NCT ID: NCT02977793

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-01-31

Brief Summary

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

Detailed Description

The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium by capturing an image of corneal endothelium tissues. without making contact, analyzing the captured image, and calculating data such as cell density.

Conditions

Corneal and Endothelial Cell Measurements

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-pathologic young adults

18-28 years old

Tomey EM-4000 Specular Microscope

Intervention Type: DEVICE

Konan CellChek XL Specular Microscope

Intervention Type: DEVICE

Non-pathologic adults

29-80 years old

Tomey EM-4000 Specular Microscope

Intervention Type: DEVICE

Konan CellChek XL Specular Microscope

Intervention Type: DEVICE

Pathologic adults

29-80 years old

Tomey EM-4000 Specular Microscope

Intervention Type: DEVICE

Konan CellChek XL Specular Microscope

Intervention Type: DEVICE

Interventions

Tomey EM-4000 Specular Microscope

Intervention Type: DEVICE

Konan CellChek XL Specular Microscope

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;

3. Subjects who agree to participate in the study.

1. 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;

2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;

3. Subjects who agree to participate in the study;

4. At least one eye with any of the following conditions:

1. History of post-op surgical trauma including pseudophakic or aphakic bullous keratopathy

2. History of corneal transplant

3. Physical injury or trauma to the cornea

4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies

5. Keratoconus

6. Long-term polymethyl methacrylate (PMMA) contact lens use (greater than 3 years).

Exclusion Criteria

1. History of post-op surgical trauma including bullous keratopathy;

2. History of corneal transplant;

3. Evidence of physical injury or trauma to the cornea;

4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies;

5. Keratoconus;

6. Long-term PMMA contact lens use (greater than 3 years);

7. 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;

8. Fixation problems which may prevent obtaining good Tomey EM-4000 and Konan CellChek XL images in either eye.

1. 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;

2. Fixation problems which may prevent obtaining at least poor quality Tomey EM-4000 and Konan CellChek XL images in either eye.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tomey Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TOMEY-EM4000-US-001

Identifier Type: -

Identifier Source: org_study_id