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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02138279
Other study ID # TOPCON-TON-US-0001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2014
Est. completion date December 2014

Study information

Verified date June 2022
Source Topcon Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date December 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Andover Eye Associates Andover Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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