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OpenTrials
Completed

NCT Number: NCT02427256

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topcon Specular Microscope SP-1P

Device

Konan Specular Microscope CELLCHEK XL

Device

Primary outcomes

  1. Corneal endothelial cell density

    Time frame: Single time point - 1 day

  2. Coefficient of variation of endothelial cell area

    Time frame: Single time point - 1 day

  3. Corneal endothelial cell % hexagonality

    Time frame: Single time point - 1 day

  4. Central corneal thickness

    Time frame: Single time point - 1 day

Sponsors and collaborators

Lead sponsor

Topcon Medical Systems, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 27, 2015
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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