EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS

NCT ID: NCT06266351

Last Updated: 2024-11-05

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

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-12

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension Normal Tension Glaucoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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IOP measurement with CATS

This is observational IOP measurement

Intervention Type DEVICE

IOP measurement of patients having LASIK with both CATS and GAT

IOP measurement with GAT

This is observational IOP measurement

Intervention Type DEVICE

IOP measurement of patients having LASIK with both CATS and GAT

Interventions

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This is observational IOP measurement

IOP measurement of patients having LASIK with both CATS and GAT

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Intuor Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Eye Consultants

Tucson, Arizona, United States

Site Status

Eye Specialty Group

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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LASIKIOP

Identifier Type: -

Identifier Source: org_study_id

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