Horizontal vs. Vertical Positioning of the iCare Rebound Tonometer and Effects on Intraocular Pressure Readings

NCT ID: NCT02837536

Last Updated: 2017-03-08

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

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-23

Study Completion Date

2016-12-23

Brief Summary

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The goal of this study is to evaluate the agreement between intraocular pressure (IOP) measurements taken by iCare, held in both vertical and horizontal positions. In addition, iCare measurements will be compared against pneumotonometry measurements to assess for accuracy.

Detailed Description

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Conditions

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Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Horizontal iCare

In the horizontal iCare arm, these patients were randomized to have their IOP measured with the iCare tonometer held in the horizontal position first and then their IOP measured with the iCare tonometer held in the vertical position.

Group Type ACTIVE_COMPARATOR

Horizontal iCare

Intervention Type OTHER

IOP of the right eye will be measured using the iCare tonometer held in the horizontal position first and then in the vertical position.

Vertical iCare

Intervention Type OTHER

IOP of the right eye will be measured using the iCare tonometer held in the vertical position first and then in the horizontal position.

Vertical iCare

In the vertical iCare arm, these patients were randomized to have their IOP measured with the iCare tonometer held in the vertical position first and then their IOP measured with the iCare tonometer held in the horizontal position.

Group Type ACTIVE_COMPARATOR

Horizontal iCare

Intervention Type OTHER

IOP of the right eye will be measured using the iCare tonometer held in the horizontal position first and then in the vertical position.

Vertical iCare

Intervention Type OTHER

IOP of the right eye will be measured using the iCare tonometer held in the vertical position first and then in the horizontal position.

Interventions

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Horizontal iCare

IOP of the right eye will be measured using the iCare tonometer held in the horizontal position first and then in the vertical position.

Intervention Type OTHER

Vertical iCare

IOP of the right eye will be measured using the iCare tonometer held in the vertical position first and then in the horizontal position.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Must be able to understand and sign and informed consent form that has been approved by an Institutional Review Board/Ethics Committee

Exclusion Criteria

* Evidence of corneal epithelial defects or pathology affecting corneal rigidity
* Use of topical ophthalmic medications (except for artificial tears)
* History or corneal surgeries
* Any condition that would prevent or inhibit intraocular pressure measurements using iCare or pneumotonometry
* Evidence of ocular infection 30 days prior to enrollment
* Allergy to proparacaine or latex
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Robert Cizik Eye Clinic

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Robert Feldman

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert M. Feldman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Robert Cizik Eye Clinic

Locations

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Robert Cizik Eye Clinic

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-16-0396

Identifier Type: -

Identifier Source: org_study_id

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