Healthy ParticipantsPhase 4NCT01325324
Comparison of Different Portable Tonometers (Icare Pro, TONO-Pen AVIA, Perkins Tonometer, PASCAL Hand Held Dynamic Contour Tonometer)
A Phase 4 study testing measurement of intraocular pressure in people with Healthy Participants, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Participants
- What is being tested?
- measurement of intraocular pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2011to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- healthy patients of at least 18 years of age or above
Who cannot join
- diagnosis of glaucoma or other optic neuropathies
- corneal disorder that make IOP measurement impossible
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Ophthalmic Clinic
Zurich, Canton of Zurich, 8091
About this study
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
- Conditions
- Healthy Participants
- Being tested
- measurement of intraocular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of intraocular pressureDevice
Also called 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)
Intraocular pressure will be measured with the following devices (each 2 times)at the first and only study visit
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | Study group Receives: Device: measurement of intraocular pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
the intraocular pressure will be measured at the first and only study visit (Visit 1, day 0)
Measured: Study Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Funk, Prof. MD, Principal investigator, University Hospital Zurich, Ophtalmic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325324
- Sponsor's protocol ID
- portable-Tono-Study
- Status last verified
- Dec 2014
- First submitted
- 14 Mar 2011
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24006952
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Portable Tonometers (Icare Pro, TONO-Pen AVIA, Perkins Tonometer, PASCAL Hand Held Dynamic Contour Tonometer)
- ClinicalTrials.gov ID
- NCT01325324
- Acronym / sponsor ID
- portable-Tono-Study
- Conditions
- Healthy Participants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Device: measurement of intraocular pressureStudy group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy patients of at least 18 years of age or above
Key exclusion criteria (2 listed)
- diagnosis of glaucoma or other optic neuropathies
- corneal disorder that make IOP measurement impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of intraocular pressureAlso: 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)Intraocular pressure will be measured with the following devices (each 2 times)at the first and only study visit | Device | Study group |
Primary outcome
intraocular pressure
Time frame: Study Visit 1
the intraocular pressure will be measured at the first and only study visit (Visit 1, day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Derived from this study: PubMed 24006952Schweier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Funk, Prof. MD principal investigator
University Hospital Zurich, Ophtalmic Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing measurement of intraocular pressure in people with Healthy Participants, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (time frame: Study Visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01325324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.