EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS | NCT06266351

Studies
EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS

NCT06266351

Sponsor

Intuor Technologies, Inc.

Status

Completed

Last Update Posted

Nov 5, 2024Actual

Enrollment

198Actual

Phase

Not provided

Conditions

Glaucoma
Ocular Hypertension
Normal Tension Glaucoma

Interventions

This is observational IOP measurement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2024Actual

Primary Completion Date

Jul 1, 2024Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

Feb 11, 2024

First Submission Date that Met QC Criteria

Feb 11, 2024

First Posted Date

Feb 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2024

Last Update Posted Date

Nov 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

198Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IOP measurement with CATS			Device: This is observational IOP measurement
IOP measurement with GAT			Device: This is observational IOP measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
This is observational IOP measurement	Device	IOP measurement of patients having LASIK with both CATS and GAT	IOP measurement with CATS IOP measurement with GAT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Eye Consultants		Tucson	Arizona	85710	United States
Eye Specialty Group

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

likely will provide deindentified data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D057066	Low Tension Glaucoma

Ancestor Terms

ID	Term
D005128	Eye Diseases
D009901	Optic Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided