NCT04180111

Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 18 (estimated)
• Sponsor: Intuor Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DEVICE	CATS Tonometer	CATS Tonometer Prism

Timeline

• Start date: 2019-05-05
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2019-11-27
• Last updated: 2019-11-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study