GlaucomaNCT04911387
iCare® Home vs Goldmann Applanation Tonometry
An observational study of Glaucoma and Open Angle Glaucoma, run by St. Erik Eye Hospital at 1 site in Sweden.
Trial summary
Self-tonometry with iCare Home is regularly performed at Sankt Erik's Eye Hospital since a few years back. The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method, Goldman applanation tonometry… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Intraocular pressure measurments
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2020to 31 Oct 2020
- Phase
- Observational
- 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
Study population: All consecutive patients who are referred to the clinic to perform a Eye pressure curve with iCare® Home are offered to participate in the study. The patient him-/herself or someone accompanying him/her may perform the measurements. Volunteer without an eye history to participate.
Who may be able to join
- primary open angle glaucoma (POAG)
- pseudo-exfoliation glaucoma (PEX)
- ocular hypertension (OHT)
- no eye disease,
Who cannot join
- inability to perform measurements due to limited hand or arm mobility (eg rheumatism, tremor)
- measurements outside the iCare® Home manufacturer's recommendations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: iCare® Home vs Goldmann Applanation Tonometry: Agreement of the Methods and Comparison of Inter-observer Variation at a Tertiary Eye Centre
Self-tonometry with iCare Home is regularly performed at Sankt Erik's Eye Hospital since a few years back. The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method, Goldman applanation tonometry (GAT), by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.
Read the detailed description
Since a few years back, self-tonometry with iCare® Home has been available in glaucoma care. Sankt Erik's Eye Hospital was first in Sweden to use the new technology. Several studies have shown good agreement between measurements made by patients or healthcare professionals with iCare® Home and Goldman applanation tonometry (GAT). However, some researchers raise critical voices about the reliability of iCare® Home measurements because they can differ from GAT. GAT is considered the gold standard method of tonometry to which all other instruments are compared. But like all other methods, GAT has some limitations.
At the clinic, the eye pressure is usually measured with GAT by different staff (ophthalmological nurses, opticians or doctors) from visit to visit. This can sometimes lead to pressure variations that may affect the follow-up of glaucoma patients. This raises the question of whether the difference between GAT and iCare® Home is statistically and clinically significant.
The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method GAT by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.
- Being tested
- Intraocular pressure measurments
- Keywords
- intraocular pressure, GAT, rebound tonometry, self-tonometry, iCare® Home
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressure measurmentsDevice
Intraocular pressure measurements with iCare Home by participants (patients, volunteers) and healthcare staff as well as intraocular pressure measurements with GAT by participants different healthcare staff.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between iCare® Home inter-user measurements
iCare® Home measurements made by participants (patients and volunteers) will be compared to iCare® Home measurements made by trainers' using the same device on the same occasion
Measured: 12 months
Correlation between GAT measurements made by different healthcare personnel
GAT measurements made by iCare® Home trainers will be compared to GAT measurements made by other available healthcare personnel using a different device on the same occasion
Measured: 12 months
Secondary outcomes (1)
Agreement between iCare® Home tonometry and GAT
Agreement, repeatability and reliability of measurements made with iCare® Home tonometry and GAT will be assessed using Bland Altman analysis, ANOVA and interclass correlation coefficient (ICC).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Apr 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Erik Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enping Chen, St. Erik Eye Hospital
- Investigators
- Enping Chen, MD Ph D, Principal investigator, St. Erik Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911387
- Sponsor's protocol ID
- iCare Home vs GAT
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- 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 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCare® Home vs Goldmann Applanation Tonometry: Agreement of the Methods and Comparison of Inter-observer Variation at a Tertiary Eye Centre
- ClinicalTrials.gov ID
- NCT04911387
- Acronym / sponsor ID
- iCare Home vs GAT
- Keywords
- intraocular pressure, GAT, rebound tonometry, self-tonometry, iCare® Home
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- St. Erik Eye HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 3 Jun 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.
Self-tonometry with iCare Home is regularly performed at Sankt Erik's Eye Hospital since a few years back. The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method, Goldman applanation tonometry (GAT), by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.
Detailed description
Since a few years back, self-tonometry with iCare® Home has been available in glaucoma care. Sankt Erik's Eye Hospital was first in Sweden to use the new technology. Several studies have shown good agreement between measurements made by patients or healthcare professionals with iCare® Home and Goldman applanation tonometry (GAT). However, some researchers raise critical voices about the reliability of iCare® Home measurements because they can differ from GAT. GAT is considered the gold standard method of tonometry to which all other instruments are compared. But like all other methods, GAT has some limitations.
At the clinic, the eye pressure is usually measured with GAT by different staff (ophthalmological nurses, opticians or doctors) from visit to visit. This can sometimes lead to pressure variations that may affect the follow-up of glaucoma patients. This raises the question of whether the difference between GAT and iCare® Home is statistically and clinically significant.
The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method GAT by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who are referred to the clinic to perform a Eye pressure curve with iCare® Home are offered to participate in the study. The patient him-/herself or someone accompanying him/her may perform the measurements. Volunteer without an eye history to participate.
Key inclusion criteria (4 listed)
- primary open angle glaucoma (POAG)
- pseudo-exfoliation glaucoma (PEX)
- ocular hypertension (OHT)
- no eye disease,
Key exclusion criteria (2 listed)
- inability to perform measurements due to limited hand or arm mobility (eg rheumatism, tremor)
- measurements outside the iCare® Home manufacturer's recommendations.
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 |
|---|---|---|
| Intraocular pressure measurmentsIntraocular pressure measurements with iCare Home by participants (patients, volunteers) and healthcare staff as well as intraocular pressure measurements with GAT by participants different healthcare staff. | Device | – |
Primary outcome
Correlation between iCare® Home inter-user measurements
Time frame: 12 months
iCare® Home measurements made by participants (patients and volunteers) will be compared to iCare® Home measurements made by trainers' using the same device on the same occasion
Correlation between GAT measurements made by different healthcare personnel
Time frame: 12 months
GAT measurements made by iCare® Home trainers will be compared to GAT measurements made by other available healthcare personnel using a different device on the same occasion
1 secondary outcome
Agreement between iCare® Home tonometry and GAT
Time frame: 12 months
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 3 Jun 2021.
- 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.
Enping Chen, MD Ph D principal investigator
St. Erik Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Open Angle Glaucoma, run by St. Erik Eye Hospital at 1 site in Sweden.
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 4 inclusion and 2 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 3 Jun 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 Sweden. 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?
Correlation between iCare® Home inter-user measurements (time frame: 12 months). The study lists 2 primary outcomes in all. 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 3 Jun 2021.