NCT01325324

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 6, 2015

Status Verified

December 1, 2014

Enrollment Period

4.8 years

First QC Date

March 14, 2011

Last Update Submit

January 5, 2015

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    the intraocular pressure will be measured at the first and only study visit (Visit 1, day 0)

    Study Visit 1

Study Arms (1)

Study group

OTHER

Study group

Device: measurement of intraocular pressure

Interventions

measurement of intraocular pressureDEVICE

Intraocular pressure will be measured with the following devices (each 2 times)at the first and only study visit

Also known as: 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)
Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • diagnosis of glaucoma or other optic neuropathies
  • corneal disorder that make IOP measurement impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Ophthalmic Clinic

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Schweier C, Hanson JV, Funk J, Toteberg-Harms M. Repeatability of intraocular pressure measurements with Icare PRO rebound, Tono-Pen AVIA, and Goldmann tonometers in sitting and reclining positions. BMC Ophthalmol. 2013 Sep 5;13:44. doi: 10.1186/1471-2415-13-44.

    PMID: 24006952DERIVED

Study Officials

  • Jens Funk, Prof. MD

    University Hospital Zurich, Ophtalmic Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 29, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 6, 2015

Record last verified: 2014-12

Locations

CH(1)