Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness M… (NCT02138279) | Clinical Trial Compass
CompletedNot Applicable
Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements
United States65 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range
18 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:
* 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.
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 measurements from predicate vs. investigational device
Timeframe: Single timepoint - 1 day
2
Agreement of central corneal thickness measurements from predicate vs. investigational device