Intraocular PressureNCT07022054
iCare IC1000 Alignment Study
A study testing iCare IC1000 measurement in people with Intraocular Pressure, run by Icare Finland Oy at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the performance of the alignment feature of iCare IC1000 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 IC1000 measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2025to 5 Aug 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
- Central corneal scarring
- Microphthalmos
- Buphthalmos
- Contact lens use during measurement or hard lenses 24h prior to measurement
- Dry eyes (clinically significant)
Show all 10Show fewer
- Nystagmus
- Keratoconus
- Any other corneal or conjunctival pathology or infection relevant to this study
- Coloboma or other pupil deformation
Trial locations and contacts
1 site in 1 country.
United States1 site
Clear Vue Laser Eye Center
Lake Worth, Florida, 33467
About this study
The primary objective of this study is to evaluate the performance of the alignment feature of iCare IC1000 tonometer.
- Conditions
- Intraocular Pressure
- Being tested
- iCare IC1000 measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCare IC1000 measurementDevice
Measurement of intraocular pressure with iCare IC1000
| Study group | Role | What they receive |
|---|---|---|
| Measurement of IOP Values | Experimental | Not described Receives: Device: iCare IC1000 measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Number of participants with successful intraocular pressure (IOP) measurements using the alignment feature of the iCare IC1000 tonometer during a single clinic visit.
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start22 May 2025
- Primary completion5 Aug 2025
- Study completion5 Aug 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT07022054
- Sponsor's protocol ID
- TA032-168
- Status last verified
- Aug 2025
- First submitted
- 22 May 2025
- Last updated
- 12 Aug 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCare IC1000 Alignment Study
- ClinicalTrials.gov ID
- NCT07022054
- Acronym / sponsor ID
- TA032-168
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icare Finland OyIndustry (pharma, biotech, devices)
- Study start
- 22 May 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 15 Jun 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 primary objective of this study is to evaluate the performance of the alignment feature of iCare IC1000 tonometer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of IOP Values | Experimental | Device: iCare IC1000 measurement |
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 (10 listed)
- Subjects with only one functional eye
- Central corneal scarring
- Microphthalmos
- Buphthalmos
- Contact lens use during measurement or hard lenses 24h prior to measurement
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 IC1000 measurementMeasurement of intraocular pressure with iCare IC1000 | Device | Measurement of IOP Values |
Primary outcome
Primary Objective
Time frame: Through study completion, an average of 2 months
Number of participants with successful intraocular pressure (IOP) measurements using the alignment feature of the iCare IC1000 tonometer during a single clinic visit.
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 12 Aug 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 IC1000 measurement 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 10 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 12 Aug 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?
Primary Objective (time frame: Through study completion, an average of 2 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 12 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.