Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-05

Study Completion Date

2019-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Keratoconus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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CATS Tonometer

CATS Tonometer Prism

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

101 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No