NCT02989909

Clinical Evaluation of CATS Tonometer Prism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Intuor Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Prospective, open-labeled, randomized, controlled, multicenter study at two clinical investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT). Of the 200 eyes, at least 10 highly astigmatic eyes (\>3 D of corneal astigmatism) each in the low, medium and high IOP ranges shall have the same clinical testing and analysis of results, with the analysis kept separate from that of the main group.

Conditions

• Ocular Hypertension

Interventions

Type	Name	Description
DEVICE	CATS tonometer prism	demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range
DEVICE	Goldmann tonometer prism	demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-12-12
• Last updated: 2018-08-08

Locations

1 site across 1 country: United States