NCT06266351CompletedNot Applicable
EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS
Intuor Technologies, Inc.2 sites in 1 country198 target enrollmentStarted: February 12, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 198
- Locations
- 2
- Primary Endpoint
- IOP measurement difference between CATS and GAT in LASIK patients
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
IOP measurement difference between CATS and GAT in LASIK patients
Time Frame: single measurement 1 day
IOP measurement
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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