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

Healthy Participants Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01325324
• Other study ID #: portable-Tono-Study
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: March 14, 2011
• Last updated: January 5, 2015
• Start date: March 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Device:
• measurement of intraocular pressure
Intraocular pressure will be measured with the following devices (each 2 times)at the first and only study visit

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Ophthalmic Clinic	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure	the intraocular pressure will be measured at the first and only study visit (Visit 1, day 0)	Study Visit 1	No