Keratoconus
Conditions
Brief summary
The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.
Detailed description
This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative sites in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.
Interventions
DEVICECATS Tonometer
CATS Tonometer Prism
Sponsors
Intuor Technologies, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 101 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients, at least 18 years of age * Subject has a clear understanding and agrees to all the conditions of the informed consent form
Exclusion criteria
* • Subject has undergone ocular surgery within the last 3 months * Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk * Pregnant or nursing women * Those who have had corneal surgery including corneal laser surgery * Microphthalmos * Buphthalmos * Severe Dry eyes * Lid squeezers - blepharospasm * Nystagmus * corneal or conjunctival infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP measurement | 6 months | comparative IOP measurement between CATS and GAT tonometer prisms |
Countries
United States
Outcome results
None listed