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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837536
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : March 8, 2017
Sponsor:
Collaborator:
Robert Cizik Eye Clinic
Information provided by (Responsible Party):
Robert Feldman, 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.

Condition or disease Intervention/treatment Phase
Intraocular Pressure Other: Horizontal iCare Other: Vertical iCare Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Horizontal vs. Vertical Positioning of the iCare Rebound Tonometer and Effects on Intraocular Pressure Readings
Actual Study Start Date : June 23, 2016
Actual Primary Completion Date : July 20, 2016
Actual Study Completion Date : December 23, 2016

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.




Primary Outcome Measures :
  1. IOP taken by iCare - horizontal [ Time Frame: 1 Day ]
  2. IOP taken by iCare - vertical [ Time Frame: 1 Day ]
  3. IOP taken by pneumatonometer [ Time Frame: 1 Day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837536


Locations
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United States, Texas
Robert Cizik Eye Clinic
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Robert Cizik Eye Clinic
Investigators
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Principal Investigator: Robert M. Feldman, M.D. Robert Cizik Eye Clinic
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Responsible Party: Robert Feldman, M.D., The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02837536    
Other Study ID Numbers: HSC-MS-16-0396
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No