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NCT06266351 Clinical Trial

EVALUATION OF CATS TONOMETER PRISM IN LASIK SUBJECTS

Glaucoma Clinical Trial

Official title:
EVALUATION OF CATS TONOMETER PRISM IN LASIK SUBJECTS

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06266351
Other study ID # LASIKIOP
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 12, 2024
Est. completion date August 1, 2024

Study information
Verified date February 2024
Source Intuor Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date August 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• This is observational IOP measurement
IOP measurement of patients having LASIK with both CATS and GAT

Locations
Country Name City State
United States Eye Specialty Group Memphis Tennessee
United States Arizona Eye Consultants Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Intuor Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary IOP measurement difference between CATS and GAT in LASIK patients IOP measurement single measurement 1 day
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