Intraocular PressureNCT06450587
Intraocular Pressure Data Collection With Tonometers
A study testing iCare IC1000, iCare ST500 and iCare IC200 in people with Intraocular Pressure, run by Icare Finland Oy at 2 sites in Slovenia.
Trial summary
The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of 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 ST500 and iCare IC200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesSlovenia
- Study dates
- 29 May 2024to 7 Feb 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
- Age ≥ 18 years
Who cannot join
- Subjects with only one functional eye
- Subjects having poor or eccentric fixation in the study eye(s)
- High corneal astigmatism \>3D in the study eye(s)
- Central corneal scarring
- History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
- Microphthalmos
Show all 14Show 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
- Cataract Extraction within last 2 months in the study eye(s)
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
Optika Mesec d.o.o.
Bled, Municipality of Bled, 4260
Vid d.o.o.
Kromberk, Urban Municipality of Nova Gorica, 5000
About this study
The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years).
The intraocular pressure of the participants will be measured with four different tonometers.
- Conditions
- Intraocular Pressure
- Being tested
- iCare IC1000, iCare ST500, iCare IC200, GAT
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)
iCare ST500Device
Measurement of Intraocular Pressure (IOP)
iCare IC200Device
Measurement of Intraocular Pressure (IOP)
GATDevice
Measurement of Intraocular Pressure (IOP)
| Study group | Role | What they receive |
|---|---|---|
| Measurement of IOP Values | Experimental | Measurement of IOP pressure with four different tonometers. Receives: Device: iCare IC1000; Device: iCare ST500; Device: iCare IC200; Device: GAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
The primary objective of this study is to measure wide range of IOP values with the new tonometer and three comparator devices. The IOP value's unit of measure will be mmHg.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start29 May 2024
- Primary completion7 Feb 2025
- Study completion7 Feb 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
- 151 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
- NCT06450587
- Sponsor's protocol ID
- TA032-082
- Status last verified
- Apr 2025
- First submitted
- 31 May 2024
- Last updated
- 30 Apr 2025
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure Data Collection With Tonometers
- ClinicalTrials.gov ID
- NCT06450587
- Acronym / sponsor ID
- TA032-082
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Icare Finland OyIndustry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 10 Jun 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.
The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years).
The intraocular pressure of the participants will be measured with four different tonometers.
Study design
- Primary purpose
- Diagnosis
- 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, Device: iCare ST500, Device: iCare IC200, Device: GATMeasurement of IOP pressure with four different tonometers. |
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 (14 listed)
- Subjects with only one functional eye
- Subjects having poor or eccentric fixation in the study eye(s)
- High corneal astigmatism \>3D in the study eye(s)
- Central corneal scarring
- History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
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) | Device | Measurement of IOP Values |
| iCare ST500Measurement of Intraocular Pressure (IOP) | Device | Measurement of IOP Values |
| iCare IC200Measurement of Intraocular Pressure (IOP) | Device | Measurement of IOP Values |
| GATMeasurement of Intraocular Pressure (IOP) | Device | Measurement of IOP Values |
Primary outcome
Primary Objective
Time frame: Through study completion, an average of 4 months
The primary objective of this study is to measure wide range of IOP values with the new tonometer and three comparator devices. The IOP value's unit of measure will be mmHg.
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 30 Apr 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.
2 sites 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 ST500 and iCare IC200 in people with Intraocular Pressure, run by Icare Finland Oy at 2 sites in Slovenia.
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 14 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 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. 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 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 30 Apr 2025.