Intraocular PressureNCT05742009
iCare ST500 Clinical Trial
A study testing iCare ST500, GAT and iCare IC200 in people with Intraocular Pressure, run by Icare Finland Oy at 1 site in Canada.
Trial summary
Clinical validation of iCare ST500 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 ST500, GAT and iCare IC200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jun 2023to 14 Nov 2023
- 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
- Patients at least 18 years old
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 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(s)
- Cataract Extraction within last 2 months in the study eye(s)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Nova Scotia Health/Dalhousie University
Halifax, Nova Scotia, B3H 2Y9
About this study
Official title: Clinical Validation of a Slit Lamp Mounted Rebound Tonometer
Clinical validation of iCare ST500 tonometer per ANSI Z80.10:2014 standard
- Conditions
- Intraocular Pressure
- Being tested
- iCare ST500, GAT, iCare IC200
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCare ST500Device
Measurement of Intraocular Pressure (IOP)
GATDevice
Measurement of Intraocular Pressure (IOP)
iCare IC200Device
Measurement of Intraocular Pressure (IOP)
| Study group | Role | What they receive |
|---|---|---|
| iCare ST500 vs GAT and iCare IC200 | Experimental | Measurement of intraocular pressure (IOP) with iCare ST500 compared to GAT and iCare IC200. Measurements will be performed in three categories: Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (≥23 mmHg). Receives: Device: iCare ST500; Device: GAT; Device: iCare IC200 |
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 Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.
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 posted23 Feb 2023
- Study start5 Jun 2023
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
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
- 165 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
- NCT05742009
- Sponsor's protocol ID
- TA04-185
- Status last verified
- Nov 2023
- First submitted
- 2 Feb 2023
- Last updated
- 30 Nov 2023
- 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 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Slit Lamp Mounted Rebound Tonometer
- ClinicalTrials.gov ID
- NCT05742009
- Acronym / sponsor ID
- TA04-185
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Icare Finland OyIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 23 Feb 2023 (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 ST500 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 ST500 vs GAT and iCare IC200 | Experimental | Device: iCare ST500, Device: GAT, Device: iCare IC200Measurement of intraocular pressure (IOP) with iCare ST500 compared to GAT and iCare IC200. Measurements will be performed in three categories: Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (≥23 mmHg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at least 18 years old
Key exclusion criteria (15 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 ST500Measurement of Intraocular Pressure (IOP) | Device | iCare ST500 vs GAT and iCare IC200 |
| GATMeasurement of Intraocular Pressure (IOP) | Device | iCare ST500 vs GAT and iCare IC200 |
| iCare IC200Measurement of Intraocular Pressure (IOP) | Device | iCare ST500 vs GAT and iCare IC200 |
Primary outcome
Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers
Time frame: Through study completion, an average of 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 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 30 Nov 2023.
- 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, GAT and iCare IC200 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 30 Nov 2023. 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 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 Nov 2023.