Intraocular PressureNCT05162989
iCare HOME2 Clinical Trial
A study testing iCare HOME2 vs iCare IC200 in people with Intraocular Pressure and Glaucoma, run by Icare Finland Oy at 1 site in United States.
Trial summary
The aim of this clinical study is to provide information about the variability of the intraocular pressure (IOP) self-measurements with the iCare HOME2 tonometer in comparison to the variability of the IOP measurements with the reference tonometer (iCare IC200), over a wide range of IOP values. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure, Glaucoma
- What is being tested?
- iCare HOME2 vs iCare IC200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2021to 15 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glaucoma patients having confirmed optic nerve damage with visual field defects consistent with the glaucomatous optic neuropathy or
- Glaucoma-suspects being followed because of elevated IOP, and/or because of other risk factors for developing glaucoma or optic nerve damage.
Who cannot join
- Active ocular infection (e.g., pink eye or infectious conjunctivitis)
- Recent trauma to the eye including corneal laceration or corneal/scleral perforation
- Disabling arthritis or difficulty handling the tonometer
- Severe difficulty in opening the eyes including abnormal contractions or twitches of the eyelid (blepharospasm)
- Involuntary, rapid, and repetitive eye movements (nystagmus)
- Low uncorrected near visual acuity of 20/200 or below
Show all 21Show fewer
- Significant glaucomatous central field loss
- Only one functional eye
- Poor or off-center visual fixation
- Poor hearing and/or communicates using sign language
- Keratoconus (or other corneal disorder)
- Congenitally small eye (microphthalmos)
- Enlarged eyeball from the childhood glaucoma (buphthalmos)
- Previous experience using or interacting with the HOME tonometer during usability tests or clinical trials
- Any affiliation with Icare and its employees
- High corneal astigmatism (>3d)
- History of prior invasive corneal surgery including corneal laser surgery less than six months ago (e.g., LASIK, LASEK, Smile)
- Corneal scarring
- Very thick or very thin corneas (central corneal thickness greater than 600 μm or less than 500 μm)
- Cataract extraction within the last 2 months
- Wearing contact lenses during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
East West Eye Institute
Los Angeles, California, 90013
About this study
The aim of this clinical study is to provide information about the variability of the intraocular pressure (IOP) self-measurements with the iCare HOME2 tonometer in comparison to the variability of the IOP measurements with the reference tonometer (iCare IC200), over a wide range of IOP values.
Read the detailed description
The clinical study is planned to estimate the variability of the IOP measurement of iCare HOME2 and IC200. In the study, the subjects will learn to operate the iCare HOME2 tonometer independently by using the labeling materials provided to them. Once they learn to operate the tonometer, subjects will take three self-measurements on the selected eye both in sitting and supine position.
The variability of the measurement results taken with iCare HOME2 will be compared to the variability of the measurement results taken with iCare IC200 by using the recorded results from the study subjects.
- Conditions
- Intraocular Pressure, Glaucoma
- Being tested
- iCare HOME2 vs iCare IC200
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCare HOME2 vs iCare IC200Device
Measurement of IOP with iCare HOME2 compared with iCare IC200.
| Study group | Role | What they receive |
|---|---|---|
| iCare HOME2 vs iCare IC200 | Experimental | Measurement of intraocular pressure (IOP) with iCare IC200 reference tonometer compared to iCare HOME2 test tonometer. Measurement will be performed to categorize each subject as having Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (≥23 mmHg). Receives: Device: iCare HOME2 vs iCare IC200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability of IOP measurements
Repeatability of IOP measurements comparison of iCare HOME2 vs iCare IC200
Measured: Through study completion, an average of 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start26 Nov 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icare Finland Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle A Sato, MD, Principal investigator, East West Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162989
- Sponsor's protocol ID
- TA023-207
- Status last verified
- Dec 2021
- First submitted
- 16 Dec 2021
- Last updated
- 20 Dec 2021
- 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 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCare HOME2 Clinical Trial
- ClinicalTrials.gov ID
- NCT05162989
- Acronym / sponsor ID
- TA023-207
- Conditions
- Intraocular Pressure, Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Icare Finland OyIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 20 Dec 2021 (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 provide information about the variability of the intraocular pressure (IOP) self-measurements with the iCare HOME2 tonometer in comparison to the variability of the IOP measurements with the reference tonometer (iCare IC200), over a wide range of IOP values.
Detailed description
The clinical study is planned to estimate the variability of the IOP measurement of iCare HOME2 and IC200. In the study, the subjects will learn to operate the iCare HOME2 tonometer independently by using the labeling materials provided to them. Once they learn to operate the tonometer, subjects will take three self-measurements on the selected eye both in sitting and supine position.
The variability of the measurement results taken with iCare HOME2 will be compared to the variability of the measurement results taken with iCare IC200 by using the recorded results from the study subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCare HOME2 vs iCare IC200 | Experimental | Device: iCare HOME2 vs iCare IC200Measurement of intraocular pressure (IOP) with iCare IC200 reference tonometer compared to iCare HOME2 test tonometer. Measurement will be performed to categorize each subject as having 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Glaucoma patients having confirmed optic nerve damage with visual field defects consistent with the glaucomatous optic neuropathy or
- Glaucoma-suspects being followed because of elevated IOP, and/or because of other risk factors for developing glaucoma or optic nerve damage.
Key exclusion criteria (21 listed)
- Active ocular infection (e.g., pink eye or infectious conjunctivitis)
- Recent trauma to the eye including corneal laceration or corneal/scleral perforation
- Disabling arthritis or difficulty handling the tonometer
- Severe difficulty in opening the eyes including abnormal contractions or twitches of the eyelid (blepharospasm)
- Involuntary, rapid, and repetitive eye movements (nystagmus)
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 HOME2 vs iCare IC200Measurement of IOP with iCare HOME2 compared with iCare IC200. | Device | iCare HOME2 vs iCare IC200 |
Primary outcome
Repeatability of IOP measurements
Time frame: Through study completion, an average of 1-2 months
Repeatability of IOP measurements comparison of iCare HOME2 vs iCare IC200
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 20 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Intraocular Pressure
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Active, not recruitingObservational study
The Applanation Tonometry in GCA Pilot
Giant Cell Arteritis
Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries
Recruiting
Glaucoma Screening to Enhance At-Risk Californians' Health
Glaucoma
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
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.
Michelle A Sato, MD principal investigator
East West Eye Institute
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 HOME2 vs iCare IC200 in people with Intraocular Pressure and Glaucoma, 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 2 inclusion and 21 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 20 Dec 2021. 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?
Repeatability of IOP measurements (time frame: Through study completion, an average of 1-2 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 20 Dec 2021.