EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS

Completed

• Conditions: Glaucoma; Normal Tension Glaucoma; Ocular Hypertension
• Interventions: Device: This is observational IOP measurement

• Registration Number: NCT06266351
• Lead Sponsor: Intuor Technologies, Inc.

Brief Summary

The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-11
• Study First Submitted QC: 2024-02-11
• Study Start: 2024-02-12
• Study First Posted: 2024-02-20
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-11-03
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:

• At least 22 years of age and undergone LASIK treatment
• Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form

Exclusion Criteria

• Subjects will be excluded from participation if they meet the following criteria:

  • Subject has undergone ocular surgery within the last 3 months or LASIK within 6 months
  • Pregnant or nursing women
  • Those who have had previous corneal surgery excluding LASIK
  • Keratoconus
  • Corneal scarring
  • Microphthalmos
  • Buphthalmos
  • Dry eyes with clinical epithelial breakdown upon exam
  • Lid squeezers - blepharospasm
  • Nystagmus
  • Corneal or conjunctival infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IOP measurement with CATS	This is observational IOP measurement	-
IOP measurement with GAT	This is observational IOP measurement	-

Primary Outcome Measures

Name	Time	Method
IOP measurement difference between CATS and GAT in LASIK patients	single measurement 1 day	IOP measurement

Trial Locations

Locations (2)

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

Eye Specialty Group; 🇺🇸 Memphis, Tennessee, United States