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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02138279

Enrollment

Registered

2014-05-14

Start date

2014-04-30

Completion date

2014-12-31

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 Pachymetry, Intraocular Pressure

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Agreement of intraocular pressure measurements from predicate vs. investigational device	Single timepoint - 1 day
Agreement of central corneal thickness measurements from predicate vs. investigational device	Single time point - 1 day

Countries

United States

Outcome results