Intraocular PressureNCT07156630
Quick Measure Study for iCare ST500 and iCare IC200
A study testing iCare ST500, iCare IC200 and GAT in people with Intraocular Pressure, run by Icare Finland Oy at 1 site in United States.
Trial summary
The aim of this clinical study is to compare the agreement and precision of the intraocular pressure (IOP) results measured with the Quick Measure feature of iCare ST500 and iCare IC200 tonometers with results obtained with reference tonometers (Goldmann applanation tonometry and Tono-Vera tonometer). 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 ST500, iCare IC200 and GAT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2025to 3 Dec 2025
- 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
- 1. 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.
United States1 site
NVision Clinical Research LLC
Torrance, California, 90505
About this study
The aim of this clinical study is to compare the agreement and precision of the intraocular pressure (IOP) results measured with the Quick Measure feature of iCare ST500 and iCare IC200 tonometers with results obtained with reference tonometers (Goldmann applanation tonometry and Tono-Vera tonometer). The data will be collected and evaluated in accordance with ISO 8612:2009 "Ophthalmic Instruments - Tonometers" (at least 120 eyes divided in three IOP groups with a minimum of 40 eyes per group, 95% of the paired differences between the reference tonometer and the test tonometer must fall within the tolerance of ±5 mmHg).
- Conditions
- Intraocular Pressure
- Being tested
- iCare ST500, iCare IC200, GAT, Tonovera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCare ST500Device
Measurement of IOP
iCare IC200Device
Measurement of IOP
GATDevice
Measurement of IOP
TonoveraDevice
Measurement of IOP
| Study group | Role | What they receive |
|---|---|---|
| iCare ST500 and iCare IC200 vs GAT and Tonovera | Experimental | Not described Receives: Device: iCare ST500; Device: iCare IC200; Device: GAT; Device: Tonovera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate compliance with ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-Tonometers
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer and iCare IC200 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.
Measured: Through study completion, estimated 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start28 Aug 2025
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
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
- 122 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
- NCT07156630
- Sponsor's protocol ID
- TA04-310
- Status last verified
- Dec 2025
- First submitted
- 21 Aug 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quick Measure Study for iCare ST500 and iCare IC200
- ClinicalTrials.gov ID
- NCT07156630
- Acronym / sponsor ID
- TA04-310
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Icare Finland OyIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 5 Sep 2025 (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.
The aim of this clinical study is to compare the agreement and precision of the intraocular pressure (IOP) results measured with the Quick Measure feature of iCare ST500 and iCare IC200 tonometers with results obtained with reference tonometers (Goldmann applanation tonometry and Tono-Vera tonometer). The data will be collected and evaluated in accordance with ISO 8612:2009 "Ophthalmic Instruments - Tonometers" (at least 120 eyes divided in three IOP groups with a minimum of 40 eyes per group, 95% of the paired differences between the reference tonometer and the test tonometer must fall within the tolerance of ±5 mmHg).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCare ST500 and iCare IC200 vs GAT and Tonovera | Experimental | Device: iCare ST500, Device: iCare IC200, Device: GAT, Device: Tonovera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. 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 ST500Measurement of IOP | Device | iCare ST500 and iCare IC200 vs GAT and Tonovera |
| iCare IC200Measurement of IOP | Device | iCare ST500 and iCare IC200 vs GAT and Tonovera |
| GATMeasurement of IOP | Device | iCare ST500 and iCare IC200 vs GAT and Tonovera |
| TonoveraMeasurement of IOP | Device | iCare ST500 and iCare IC200 vs GAT and Tonovera |
Primary outcome
Demonstrate compliance with ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-Tonometers
Time frame: Through study completion, estimated 4 months
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer and iCare IC200 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.
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 11 Dec 2025.
- 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 ST500, iCare IC200 and GAT in people with Intraocular Pressure, run by Icare Finland Oy at 1 site in United States.
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 11 Dec 2025. 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 United States. 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 ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-Tonometers (time frame: Through study completion, estimated 4 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 11 Dec 2025.