Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

Keratoconus Clinical Trial

Official title:

Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04180111
• Other study ID #: CATS crosslink
• Status: Recruiting
• Start date: May 5, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: November 2019
• Source: Intuor Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 101 Years

Eligibility

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.

Related Conditions & MeSH terms

• Keratoconus

Intervention

Device:
• CATS Tonometer
CATS Tonometer Prism

Locations

Country	Name	City	State
United States	Arizona Eye Consultants	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Intuor Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP measurement	comparative IOP measurement between CATS and GAT tonometer prisms	6 months