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

Not Applicable

Completed

• Conditions: Intraocular Pressure
• Interventions: Other: Horizontal iCare; Other: Vertical iCare

• Registration Number: NCT02837536
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-06-23
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Primary Completion: 2016-07-20
• Study Completion: 2016-12-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Horizontal iCare	Vertical 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.
Vertical iCare	Horizontal 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.
Vertical iCare	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.
Horizontal iCare	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.

Primary Outcome Measures

Name	Time	Method
IOP taken by iCare - vertical	1 Day
IOP taken by pneumatonometer	1 Day
IOP taken by iCare - horizontal	1 Day

Trial Locations

Locations (1)

Robert Cizik Eye Clinic; 🇺🇸 Houston, Texas, United States