EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS

NCT06266351 | Completed FDA Device

• 1 other identifier: LASIKIOP
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 2

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.

Conditions

Glaucoma; Ocular Hypertension; Normal Tension Glaucoma

Outcome Measures

Primary Outcomes (1)

• IOP measurement difference between CATS and GAT in LASIK patients

  IOP measurement

  single measurement 1 day

Study Arms (2)

IOP measurement with CATS

Device: This is observational IOP measurement

IOP measurement with GAT

Device: This is observational IOP measurement

Interventions

This is observational IOP measurement DEVICE

IOP measurement of patients having LASIK with both CATS and GAT

IOP measurement with CATS; IOP measurement with GAT

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intuor Technologies, Inc.: lead

Study Sites (2)

Arizona Eye Consultants

Tucson, Arizona, 85710, United States

Location

Eye Specialty Group

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases; Optic Nerve Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 20, 2024
• Study Start: February 12, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-02

Locations

US (2)