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Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

I

Intuor Technologies

Status

Unknown

Conditions

Keratoconus

Treatments

Device: CATS Tonometer

Study type

Observational

Funder types

Industry

Identifiers

NCT04180111
CATS crosslink

Details and patient eligibility

About

The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

Full description

This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative sites in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 101 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male and female patients, at least 18 years of age
  • Subject has a clear understanding and agrees to all the conditions of the informed consent form

Exclusion criteria

  • • Subject has undergone ocular surgery within the last 3 months

    • Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
    • Pregnant or nursing women
    • Those who have had corneal surgery including corneal laser surgery
    • Microphthalmos
    • Buphthalmos
    • Severe Dry eyes
    • Lid squeezers - blepharospasm
    • Nystagmus
    • corneal or conjunctival infection.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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