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

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

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.

Study Overview

• Status: Completed
• Conditions: Corneal Endothelial Cell Loss
• Intervention / Treatment: Device: Topcon Specular Microscope SP-1P; Device: Konan Specular Microscope CELLCHEK XL

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ophthalmology Practice

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-Pathologic Adults age 18-28 yrs	Device: Topcon Specular Microscope SP-1P; Device: Konan Specular Microscope CELLCHEK XL
Non-Pathologic Adults age 29-80 yrs	Device: Topcon Specular Microscope SP-1P; Device: Konan Specular Microscope CELLCHEK XL
Pathologic Adults age 29-80 yrs	Device: Topcon Specular Microscope SP-1P; Device: Konan Specular Microscope CELLCHEK XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Corneal endothelial cell density	Single time point - 1 day
Coefficient of variation of endothelial cell area	Single time point - 1 day
Corneal endothelial cell % hexagonality	Single time point - 1 day
Central corneal thickness	Single time point - 1 day

Collaborators and Investigators

• Sponsor: Topcon Medical Systems, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: April 22, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Postoperative Complications; Corneal Diseases; Eye Manifestations; Corneal Endothelial Cell Loss
• Other Study ID Numbers: TOPCON-SP-1P-US-0002