Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

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.

Study Overview

• Status: Unknown
• Conditions: Keratoconus
• Intervention / Treatment: Device: CATS Tonometer

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.

• Study Type: Observational
• Enrollment (Anticipated): 18

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Recruiting
      • Arizona Eye Consultants
      • Contact: Sean McCafferty, MD; Phone Number: 520-400-4255; Email: sjmccafferty66@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 101 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Twenty three (23) Subjects 18 years and older and will be enrolled from one clinical. Subjects will be chosen from patients who are being examined for a corneal cross-linking procedure.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP measurement	comparative IOP measurement between CATS and GAT tonometer prisms	6 months

Collaborators and Investigators

• Sponsor: Intuor Technologies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2019
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: November 23, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: CATS crosslink

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No