Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements
Completed
Conditions studied: Intraocular Pressure, Corneal Pachymetry
In brief
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.
Key facts
- Study ID
- NCT02138279
- Run by
- Topcon Medical Systems, Inc.
- People needed
- 65
- Starts
- 2014-04-01
- Expected to finish
- 2014-12-01
- 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…
- 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.
You may not qualify if…
- 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.
Where it is running
- Andover Eye Associates — Andover, Massachusetts, United States
Full record on ClinicalTrials.gov
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