Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

• Conditions: Keratoconus

• Registration Number: NCT04180111
• Lead Sponsor: Intuor Technologies, Inc.

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.

Study Timeline

• Study Start: 2019-05-05
• Status Verified: 2019-11
• Study First Submitted: 2019-11-23
• Study First Submitted QC: 2019-11-26
• Last Update Submitted: 2019-11-26
• Study First Posted: 2019-11-27
• Last Update Posted: 2019-11-27
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IOP measurement	6 months	comparative IOP measurement between CATS and GAT tonometer prisms

Trial Locations

Locations (1)

Arizona Eye Consultants; 🇺🇸 Tucson, Arizona, United States