Intraocular PressureNCT06748092
Clinical Validation of iCare IC1000 Tonometer
A study testing iCare IC1000, iCare IC200 and GAT in people with Intraocular Pressure, run by Icare Finland Oy at 1 site in Canada.
Trial summary
Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- iCare IC1000, iCare IC200 and GAT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteCanada
- Study dates
- 21 Oct 2025to 24 Mar 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
Who cannot join
- Subjects with only one functional eye
- Subjects having poor or eccentric fixation in the study eye
- High corneal astigmatism >3D in the study eye
- Central corneal scarring
- History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye
- Microphthalmos
Show all 15Show fewer
- Buphthalmos
- Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
- Dry eyes (clinically significant)
- Lid squeezers - blepharospasm
- Nystagmus
- Keratoconus
- Any other corneal or conjunctival pathology or infection relevant to this study
- Central corneal thickness greater than 600 µm or less than 500 µm in the study eye
- Cataract Extraction within last 2 months in the study eye
Trial locations and contacts
1 site in 1 country.
Canada1 site
Nova Scotia Health/Dalhousie University
Halifax, Nova Scotia, B3H 2Y9
About this study
Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard
- Conditions
- Intraocular Pressure
- Being tested
- iCare IC1000, iCare IC200, GAT, Perkins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCare IC1000Device
Measurement of Intraocular Pressure (IOP) in sitting and supine position
iCare IC200Device
Measurement of Intraocular Pressure (IOP) in sitting and supine position
GATDevice
Measurement of Intraocular Pressure (IOP) in sitting position
PerkinsDevice
Measurement of Intraocular Pressure (IOP) in supine position
| Study group | Role | What they receive |
|---|---|---|
| iCare IC1000 vs GAT, iCare IC200 and Perkins | Experimental | Not described Receives: Device: iCare IC1000; Device: iCare IC200; Device: GAT; Device: Perkins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on the reference tonometer measurements. The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups.
Measured: Through study completion, an average of 6 months
Secondary outcomes (1)
Retrospective analysis of "Quick Measure" mode
The secondary objective of this study is to do a retrospective analysis of "Quick Measure" mode. Instead of 6 shots that are taken in Default Measure, Quick Measure takes only 2 shots (or 3 shots if the difference between the first two shots is greater than 2 mmHg). The Quick Measure results are calculated retrospectively from the raw data of the Default Measure results. Quick Measure comparison to reference measurements is done similarly as with Default Measure.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start21 Oct 2025
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icare Finland Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748092
- Sponsor's protocol ID
- TA032-135
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of iCare IC1000 Tonometer
- ClinicalTrials.gov ID
- NCT06748092
- Acronym / sponsor ID
- TA032-135
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Icare Finland OyIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 27 Dec 2024 (actual)
- 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.
Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCare IC1000 vs GAT, iCare IC200 and Perkins | Experimental | Device: iCare IC1000, Device: iCare IC200, Device: GAT, Device: Perkins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years
Key exclusion criteria (15 listed)
- Subjects with only one functional eye
- Subjects having poor or eccentric fixation in the study eye
- High corneal astigmatism >3D in the study eye
- Central corneal scarring
- History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye
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 |
|---|---|---|
| iCare IC1000Measurement of Intraocular Pressure (IOP) in sitting and supine position | Device | iCare IC1000 vs GAT, iCare IC200 and Perkins |
| iCare IC200Measurement of Intraocular Pressure (IOP) in sitting and supine position | Device | iCare IC1000 vs GAT, iCare IC200 and Perkins |
| GATMeasurement of Intraocular Pressure (IOP) in sitting position | Device | iCare IC1000 vs GAT, iCare IC200 and Perkins |
| PerkinsMeasurement of Intraocular Pressure (IOP) in supine position | Device | iCare IC1000 vs GAT, iCare IC200 and Perkins |
Primary outcome
Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers
Time frame: Through study completion, an average of 6 months
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on the reference tonometer measurements. The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups.
1 secondary outcome
Retrospective analysis of "Quick Measure" mode
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCare IC1000, iCare IC200 and GAT in people with Intraocular Pressure, run by Icare Finland Oy at 1 site in Canada.
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 15 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: finished, as of the sponsor's last update on 7 Apr 2026. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.