EVALUATION OF CATS TONOMETER PRISM IN LASIK SUBJECTS

Intuor Technologies

Status: Not yet enrolling

Conditions: Glaucoma; Ocular Hypertension; Normal Tension Glaucoma

Treatments: Device: This is observational IOP measurement

Study type: Observational

Funder types: Industry

Identifiers

NCT06266351

LASIKIOP

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

IOP measurement with CATS

Treatment:

Device: This is observational IOP measurement

IOP measurement with GAT

Treatment:

Device: This is observational IOP measurement