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Comparison of Different Portable Tonometers (Icare Pro, TONO-Pen AVIA, Perkins Tonometer, PASCAL Hand Held Dynamic Contour Tonometer)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Zurich.
Recruitment status was:  Enrolling by invitation
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01325324
First received: March 14, 2011
Last updated: January 5, 2015
Last verified: December 2014
  Purpose

In different cases intraocular pressure (IOP) have to measured in lying position. Therefore a lot of portable tonometers have been established. The Icare Pro is a new tonometer on the market that allows faster and more comfortable IOP-measurements. No local anesthesia is needed, what is a major advantage for the patients. In this study the investigators want to evaluate if IOP measurements with Icare Pro Tonometer are as reliable as they are with other established portable tonometers (Perkins, TONO-Pen and hand held-Dynamic Contour Tonometer).

  • Trial with medical device

Condition Intervention Phase
Healthy Participants Device: measurement of intraocular pressure Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: Study Visit 1 ]
    the intraocular pressure will be measured at the first and only study visit (Visit 1, day 0)


Estimated Enrollment: 25
Study Start Date: March 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study group
Study group
Device: measurement of intraocular pressure
Intraocular pressure will be measured with the following devices (each 2 times)at the first and only study visit
Other Names:
  • Icare Pro (Icare Finland Oy, Espoo, Finland)
  • TONO-Pen AVIA (Reichert Terchnologies Inc., Depew, NY; USA
  • Perkins Tonometer (Haag-Streit AG, Könitz, Switzerland)
  • PASCAL hand helt-Dynamic Contour Tonometer (Ziemer Ophthalmic Systems AG, Port, Switzerland)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • healthy patients of at least 18 years of age or above

Exclusion criteria:

  • diagnosis of glaucoma or other optic neuropathies
  • corneal disorder that make IOP measurement impossible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325324

Locations
Switzerland
University Hospital Zurich, Ophthalmic Clinic
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Jens Funk, Prof. MD University Hospital Zurich, Ophtalmic Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01325324     History of Changes
Other Study ID Numbers: portable-Tono-Study
Study First Received: March 14, 2011
Last Updated: January 5, 2015

ClinicalTrials.gov processed this record on July 21, 2017