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

March 6, 2017 updated by: Robert Feldman, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

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
    • Texas
      • Houston, Texas, United States, 77030
        • Robert Cizik Eye Clinic

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: 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.
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.
Active Comparator: 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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IOP taken by iCare - horizontal
Time Frame: 1 Day
1 Day
IOP taken by iCare - vertical
Time Frame: 1 Day
1 Day
IOP taken by pneumatonometer
Time Frame: 1 Day
1 Day

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Robert Cizik Eye Clinic

Investigators

  • Principal Investigator: Robert M. Feldman, M.D., Robert Cizik Eye Clinic

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)

June 23, 2016

Primary Completion (Actual)

July 20, 2016

Study Completion (Actual)

December 23, 2016

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HSC-MS-16-0396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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