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Completed

NCT Number: NCT02138279

Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements

The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.

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Key information

Conditions

Intraocular Pressure Corneal Pachymetry

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 18 years of age of either sex and any race or ethnicity;
  • Willing and able to provide written informed consent prior to any study procedures being performed;
  • Willing and able to follow all instructions and attend all study visits;
  • Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart.

Exclusion criteria

  • Only one functional eye;
  • Poor or eccentric fixation;
  • Corneal scarring or have had corneal surgery, including corneal laser surgery;
  • Microphthalmos;
  • Buphthalmos;
  • Contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
  • Dry eyes, meaning having been diagnoses by a physician with dry eyes and currently using a prescribed medication;
  • Lid squeezer - blepharospasm;
  • Nystagmus;
  • Keratoconus;
  • Any other corneal or conjunctival pathology or infection;
  • Condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

Treatment and study plan

Primary outcomes

  1. Agreement of intraocular pressure measurements from predicate vs. investigational device

    Time frame: Single timepoint - 1 day

  2. Agreement of central corneal thickness measurements from predicate vs. investigational device

    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 Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 Ophthalmic Instruments -Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 14, 2014
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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