EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS

November 3, 2024 updated by: Intuor Technologies, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Arizona Eye Consultants
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Eye Specialty Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IOP measurement with CATS
Device: This is observational IOP measurement
IOP measurement of patients having LASIK with both CATS and GAT
IOP measurement with GAT
Device: This is observational IOP measurement
IOP measurement of patients having LASIK with both CATS and GAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP measurement difference between CATS and GAT in LASIK patients
Time Frame: single measurement 1 day
IOP measurement
single measurement 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuor Technologies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

February 11, 2024

First Submitted That Met QC Criteria

February 11, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LASIKIOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

likely will provide deindentified data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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