Clinical Study for TONOREF III Tested to ANSI Z80.10-2014 (NCT07152808) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study for TONOREF III Tested to ANSI Z80.10-2014
52 participantsStarted 2022-09-02
Plain-language summary
The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device.
The secondary objective was to demonstrate that the test device was as safe as the predicate device.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. been at least 22 years of age of either sex and any race or ethnicity;
. been willing and able to provide written informed consent prior to any study procedures being performed;
. been willing and able to follow all instructions and attend all study visits;
. corneal astigmatism of ≤3D and corneal thickness of 500-600 μm in at least one eye.
Exclusion criteria
. have only one functional eye;
. have poor or eccentric fixation in the study eye;
. have corneal scarring or have had corneal surgery, including corneal laser surgery in the study eye
. have microphthalmos in the study eye;
. have buphthalmos in the study eye;
. be a contact lens wearer in the study eye;
. have dry eyes;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement of Intraocular Pressure
Timeframe: 1-2 study visits per subject over the course of 8 days