Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P
Completed
Conditions studied: Intraocular Pressure
In brief
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 \[510(k)\] Submissions, and to the applicable Supplemental Information Sheet. This clinical device study will also assess the substantial equivalence of TRK-2P to a predicate device in regard to pachymetry.
Key facts
- Study ID
- NCT03439774
- Run by
- Topcon Medical Systems, Inc.
- People needed
- 345
- Starts
- 2017-05-05
- Expected to finish
- 2018-06-30
- Last updated by the study team
- 2022-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Where it is running
- Andover Eye Associates — Andover, Massachusetts, United States
Full record on ClinicalTrials.gov
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