Status:
COMPLETED
Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
Lead Sponsor:
Reichert, Inc.
Conditions:
Intraocular Pressure
Glaucoma
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Determine if the Tono-Vera Tonometer accurately measures intraocular pressure (IOP). The hypothesis of this test is to confirm the Tono-Vera Tonometer is equivalent to the Goldmann Applanation Tonomet...
Detailed Description
The Tono-Vera Tonometer (Reichert, Inc.) is a portable rebound tonometer intended to measure IOP. Subjects will undergo a standard ophthalmologic examination. Subjects will then be measured with four ...
Eligibility Criteria
Inclusion
- Subjects must be male or female, between the ages of 18 and 90 years old;
- Be able and willing to provide signed informed consent
- Be able to follow study instructions
Exclusion
- Subjects with only one functional eye;
- Subjects with one eye having poor or eccentric fixation;
- Subjects with central corneal thickness greater than 600 µm or less than 500 µm (about 2 standard deviations the human mean);
- Subjects with corneal scarring or who have had corneal surgery, including corneal laser surgery;
- Subjects with concomitant ocular diseases such as: microphthalmos, buphthalmos, nystagmus, keratoconus, severe dry eye syndrome, blepharospasm, any other corneal or conjunctival pathology or infection;
- Contact lens wearers;
- Known allergy to proparacaine or fluorescein as these are used to anesthetize the eye and allow IOP measurement, respectively, when used with the GAT.
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2021
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04360369
Start Date
October 19 2020
End Date
April 28 2021
Last Update
January 3 2022
Active Locations (1)
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1
Department of Ophthalmology, Duke University
Durham, North Carolina, United States, 27705