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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02427256

Enrollment

Registered

2015-04-27

Start date

2015-02-28

Completion date

2015-02-28

Last updated

2022-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Endothelial Cell Loss

Brief 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.

Interventions

DEVICETopcon Specular Microscope SP-1P

DEVICEKonan Specular Microscope CELLCHEK XL

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026