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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01325324
First received: March 14, 2011
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 Primary Completion Date: December 2012 (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
Genders Eligible for Study:   Both
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
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

No publications provided

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: November 3, 2011
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on June 17, 2013