Clinical Trial: Clinical Evaluation of CATS Tonometer Prism
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title:
Brief 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). Fifty (50) Subjects 18 and older and will be enrolled. Subjects will be screened based on standard of care vision examination at the clinical investigation sites. All subjects will undergo a standard ophthalmic exam and informed consent. IOP will be measured using a Goldmann tonometer armature with both the standard flat GAT prism and the modified curved CATS prism alternately inserted. The only additional measurement is central corneal thickness (CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT prism and is currently standard of care.
Detailed Summary:
Sponsor: Intuor Technologies, Inc.
Current Primary Outcome:
- All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings. [ Time Frame: From date of randomization until 24 hours ]
- All subjects will have corneal thickness measurements performed and the CATS tonometer prism intraocular pressure readings will be compared to Goldmann tonometer readings using a correction value table. [ Time Frame: From date of randomization until 24 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Intuor Technologies, Inc.
Dates:
Date Received: November 28, 2016
Date Started: January 2017
Date Completion: March 2017
Last Updated: December 8, 2016
Last Verified: December 2016
