Second Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

Corneal Endothelial Cell Loss Clinical Trial

Official title:

Comparative Study of the Topcon Specular Microscope SP-1P and the Konan Specular Microscope CELLCHEK XL (Predicate Device) for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area, ％ Hexagonality, Central Corneal Thickness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427256
• Other study ID #: TOPCON-SP-1P-US-0002
• Status: Completed
• Start date: February 2015
• Est. completion date: February 2015

Study information

• Verified date: June 2022
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this clinical study is to collect additional clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria - Non-Pathologic Young Adults (18-28 years old) and Non-Pathologic Adults (29-80 years old):

• 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.

Inclusion Criteria - Pathologic Adults (29-80 years old)

• 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;

• Long term Fuch's dystrophy, Guttata, or other corneal endothelial dystrophies

• Keratoconus;

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

Exclusion Criteria - Non-Pathologic Young Adults (18-28 years old) and Non Pathologic Adults (29-80 years old)

• History of post-op surgical trauma including bullous keratopathy;

• History of corneal transplant;

• Evidence of physical injury or trauma to the cornea;

• Long term 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 quality SP-1P and CELLCHEK PLUS in either eye.

Exclusion Criteria - Pathologic Adults (29-80 years old):

• 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 quality SP-1P and CELLCHEK PLUS in either eye.

Related Conditions & MeSH terms

• Corneal Endothelial Cell Loss

Intervention

Device:
• Topcon Specular Microscope SP-1P

• Konan Specular Microscope CELLCHEK XL

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal endothelial cell density		Single time point - 1 day
Primary	Coefficient of variation of endothelial cell area		Single time point - 1 day
Primary	Corneal endothelial cell % hexagonality		Single time point - 1 day
Primary	Central corneal thickness		Single time point - 1 day