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Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements | Clinical Trials | Clareo Health

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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

NCT02138266•Topcon Medical Systems, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this clinical study is to collect 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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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;
+3 more criteria

Exclusion Criteria

•History of corneal transplant;
•Long term Fuch's dystrophy (and other corneal endothelial dystrophies);
•Keratoconus;
•Guttata;
•Diabetes mellitus type I or type II;
•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;
•All contact lens wearers;
•Fixation problems which may prevent obtaining good quality SP-1P and CELLCHEK PLUS in either eye.
•Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) SP-1P and KONAN CELLCHEK PLUS images in either eye.

Locations (1)

Andover Eye Associates

Andover, Massachusetts, United States

Key Dates

Start Date

February 1, 2014

Primary Completion Date

March 1, 2014

Completion Date

September 1, 2014

Last Updated

June 8, 2022

Enrollment

ACTUAL participants

Conditions

Corneal Endothelial Cell Loss

Interventions

Topcon Specular Microscope SP-1P

DEVICE

Konan Specular Microscope CELLCHEK XL

DEVICE

RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD

NCT02128113

Corneal Endothelial Cell LossOcular Pain+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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