CATS Tonometer IOP Reduction Latanoprost Verses Timolol

Intuor Technologies

Status and phase: Unknown; Phase 4

Conditions: Glaucoma; Drugs

Treatments: Drug: Latanoprost; Device: CATS Tonometer

Study type: Interventional

Funder types: Industry

Identifiers

NCT04178863

2019004

Details and patient eligibility

About

Topical Prostaglandin Analog vs Betablocker - Corneal Biomechanical Evaluation using CATS Tonometer Prism

Full description

This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative site 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 institution of topical prostaglandin analogs (PGA) for glaucoma treatment. Fifty percent of patients will be randomly placed on topical beta blockers as a control. The difference PGAs and beta blockers would be a measurement of the amount of corneal biomechanical changes made due to the PGA controlled for the effect of IOP lowering by the beta -blocker group.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 101 years old

Volunteers: Accepts 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

• Subjects shall be selected in accordance with the following 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 design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

lataprost

Active Comparator group

Description:

latanoprost use

Treatment:

Device: CATS Tonometer

timolol

Active Comparator group

Description:

timolol group

Treatment:

Drug: Latanoprost

Device: CATS Tonometer