Intraocular PressureNCT04485897
Self-monitoring of the Intraocular Pressure Versus Hospital-based Diurnal Monitoring
A study testing icare HOME device (Icare Oy, Vanda, Finland) in people with Intraocular Pressure, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
Glaucoma remains the leading cause of irreversible blindness worldwide. Glaucoma represents a group of diseases that lead to optic nerve damage and corresponding deterioration of the visual field. Elevated intraocular pressure remains the most important risk factor. 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 HOME device (Icare Oy, Vanda, Finland)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Nov 2020to 1 Aug 2024
- 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
- Informed consent
- Subjects aged 18 and older
- Glaucoma patients and healthy controls
- Best corrected visual acuity >0.1
- Astigmatism ≤ 3dpt.
- Good compliance
Show all 9Show fewer
- Central corneal thickness (400-650μm)
- Passed certification procedure (detailed description under: Measurements and procedures)
- Therapeutic regimen unchanged throughout the past 30 days
Who cannot join
- History of ocular trauma
- Corneal condition interfering with tonometry (keratoconus, corneal scaring) Visual acuity <0.1
- Physical or mental disability interfering with self-tonometry (e.g. arthritis, Parkinson's disease)
- Dry eye disease
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Cantonal Hospital of Lucerne
Lucerne, 6004
About this study
Official title: Can Self-monitoring of the Intraocular Pressure With the Icare HOME Make Hospital-based Diurnal Monitoring Redundant?
Glaucoma remains the leading cause of irreversible blindness worldwide. Glaucoma represents a group of diseases that lead to optic nerve damage and corresponding deterioration of the visual field.
Elevated intraocular pressure remains the most important risk factor. Interestingly, glaucomatous damage sometimes occurs despite seemingly normal intraocular pressure.
Read more
Recent studies suggest pressure peaks, which are missed under the current practice of spot intraocular measurements during office hours. In order to detect pressure peaks diurnal measurements are mandatory. Costly in-hospital diurnal measurements are the current standard.
The primary study objective is to verify that self-tonometry at home can provide valuable information when looking for pressure peaks in patients with glaucoma.
- Conditions
- Intraocular Pressure
- Being tested
- icare HOME device (Icare Oy, Vanda, Finland)
- Keywords
- Glaucoma, self-monitoring, intraocular pressure, icare HOME, rebound tonometry
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
icare HOME device (Icare Oy, Vanda, Finland)Device
icare HOME device versus hospital based measurements
| Study group | Role | What they receive |
|---|---|---|
| icare HOME | Experimental | Not described Receives: Device: icare HOME device (Icare Oy, Vanda, Finland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of an in- hospital diurnal pressure pattern of intraocular pressure to the pattern derived from self-tonometry using icare HOME in an outpatient setting.
Statistical methods for analysis of continuous method comparison data will be applied. The primary goal is to quantify the extent of agreement between two methods (Intraocular pressure measurement in-hospital and at home) and determine whether they sufficiently agree to be used interchangeably.
Measured: 4 years
Secondary outcomes (3)
variance of diurnal intraocular pressure
Quantitative evaluation of day to day variance of diurnal intraocular pressure measurement in an out-hospital setting in patients with open angle glaucoma, normal tension glaucoma and healthy controls
Measured: 4 years
Influence of daily activities
Influence of daily activities (sports, alcohol and water intake) on intraocular measurements at home (questionnaire)
Measured: 4 years
Change of treatment
Change of treatment due to intraocular pressure peaks during hospitalisation and/or measurements at home
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start26 Nov 2020
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485897
- Sponsor's protocol ID
- 895689
- Status last verified
- Mar 2024
- First submitted
- 3 Jul 2020
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Self-monitoring of the Intraocular Pressure With the Icare HOME Make Hospital-based Diurnal Monitoring Redundant?
- ClinicalTrials.gov ID
- NCT04485897
- Acronym / sponsor ID
- 895689
- Conditions
- Intraocular Pressure
- Keywords
- Glaucoma, self-monitoring, intraocular pressure, icare HOME, rebound tonometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 24 Jul 2020 (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.
Glaucoma remains the leading cause of irreversible blindness worldwide. Glaucoma represents a group of diseases that lead to optic nerve damage and corresponding deterioration of the visual field.
Elevated intraocular pressure remains the most important risk factor. Interestingly, glaucomatous damage sometimes occurs despite seemingly normal intraocular pressure.
Recent studies suggest pressure peaks, which are missed under the current practice of spot intraocular measurements during office hours. In order to detect pressure peaks diurnal measurements are mandatory. Costly in-hospital diurnal measurements are the current standard.
The primary study objective is to verify that self-tonometry at home can provide valuable information when looking for pressure peaks in patients with glaucoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| icare HOME | Experimental | Device: icare HOME device (Icare Oy, Vanda, Finland) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent
- Subjects aged 18 and older
- Glaucoma patients and healthy controls
- Best corrected visual acuity >0.1
- Astigmatism ≤ 3dpt.
Key exclusion criteria (8 listed)
- History of ocular trauma
- Corneal condition interfering with tonometry (keratoconus, corneal scaring) Visual acuity <0.1
- Physical or mental disability interfering with self-tonometry (e.g. arthritis, Parkinson's disease)
- Dry eye disease
- Known or suspected non-compliance, drug or alcohol abuse
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 HOME device (Icare Oy, Vanda, Finland)icare HOME device versus hospital based measurements | Device | icare HOME |
Primary outcome
Comparison of an in- hospital diurnal pressure pattern of intraocular pressure to the pattern derived from self-tonometry using icare HOME in an outpatient setting.
Time frame: 4 years
Statistical methods for analysis of continuous method comparison data will be applied. The primary goal is to quantify the extent of agreement between two methods (Intraocular pressure measurement in-hospital and at home) and determine whether they sufficiently agree to be used interchangeably.
3 secondary outcomes
variance of diurnal intraocular pressure
Time frame: 4 years
Influence of daily activities
Time frame: 4 years
Change of treatment
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- 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.
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 HOME device (Icare Oy, Vanda, Finland) in people with Intraocular Pressure, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphael Fritsche, MD (0041 205 33 76, raphael.fritsche@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of an in- hospital diurnal pressure pattern of intraocular pressure to the pattern derived from self-tonometry using icare HOME in an outpatient setting. (time frame: 4 years). 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 6 Mar 2024.