Status:
COMPLETED
Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P
Lead Sponsor:
Topcon Medical Systems, Inc.
Conditions:
Intraocular Pressure
Eligibility:
All Genders
18+ years
Brief Summary
The study will assess the CT-800 and TRK-2P for conformity to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification \[5...
Eligibility Criteria
Inclusion
- be at least 18 years of age of either sex and any race or ethnicity;
- be willing and able to provide written informed consent prior to any study procedures being performed;
- be willing and able to follow all instructions and attend all study visits;
Exclusion
- have only one functional eye;
- have poor or eccentric fixation in either eye;
- have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye;
- have microphthalmos in either eye;
- have buphthalmos in either eye;
- be a 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;
- have dry eyes, meaning having been diagnosed by a physician with dry eyes and currently using a prescribed medication or daily use of an artificial tear;
- be a lid squeezer - blepharospasm;
- have nystagmus in either eye;
- have keratoconus in either eye;
- have any other corneal or conjunctival pathology or infection in either eye;
- have a 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.
Key Trial Info
Start Date :
May 5 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT03439774
Start Date
May 5 2017
End Date
June 30 2018
Last Update
June 8 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Andover Eye Associates
Andover, Massachusetts, United States, 01810