GlaucomaNCT04888156
Impact of Self-tonometry on Glaucoma Treatment Decision.
An observational study of Glaucoma and Glaucoma, Open-Angle, run by St. Erik Eye Hospital at 1 site in Sweden.
Trial summary
Self-tonometry with iCare Home is performed by one hundred patients annually at Sankt Erik's Eye Hospital. The investigators want to evaluate the impact that self-tonometry results have on the clinician's choice of glaucoma treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Open-Angle, OHT - Ocular Hypertension
- What is being tested?
- Unchanged treatment and Changed treatment
- How many people
- 133 participants
- Where
- 1 siteSweden
- Study dates
- 10 May 2021to 1 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All glaucoma patients who obtained an IOP curve using an iCare Home® self-tonometer between January 2018 and December 2020 and who fulfill all the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Age ≥ 18 years
- Diagnosed with POAG (primary open-angle glaucoma), PEX (pseudo-exfoliation glaucoma) or OHT (ocular hypertension)
- Difference between patients' and staff's iCare Home® measurements less than 5 mmHg at Baseline
- Difference between Goldman Applanation tonometry (GAT) and patient's highest iCare Home® measurements less than 7 mmHg at baseline
- Monitoring over at least two days
Who cannot join
- More than one measurement with iCare Home® tonometer below 5 mmHg
- Missing more than one daily measurement with iCare Home® tonometer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Self-tonometry With iCare Home ® on Glaucoma Treatment Decision.
Self-tonometry with iCare Home is performed by one hundred patients annually at Sankt Erik's Eye Hospital. The investigators want to evaluate the impact that self-tonometry results have on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours.
Read the detailed description
Since a few years back, self-tonometry has been available in glaucoma care. Self-tonometry allows patients to measure their eye pressure themselves using a portable tonometer. Sankt Erik's Eye Hospital was the first healthcare provider in Sweden to use this new technology. The investigators have previously conducted studies that have shown good agreement between the measurements made by patients and the gold standard method, e.g. Goldman applanation tonometry (GAT) (Chen, Querat et al. 2016, Querat and Chen 2017). About one hundred patients perform pressure curves with self-tonometry annually.
As the method is used regularly, the investigators want to evaluate the impact of self-tonometry results on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours and how much they differ from GAT.
- Being tested
- Unchanged treatment, Changed treatment
- Keywords
- glaucoma, self-tonometry, treatment, IOP peaks
- 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.
Unchanged treatmentOther
Treatment is the same pre- and post self-tonometry
Changed treatmentOther
Treatment is changed post self-tonometry
| Study group | Role | What they receive |
|---|---|---|
| GAT IOP below 15 mmHg | Glaucoma patients with an IOP measured with GAT below 15 mmHg prior performance of self-tonometry with iCare Home Receives: Other: Unchanged treatment; Other: Changed treatment | |
| GAT IOP equal or above 15 mmHg | Glaucoma patients with an IOP measured with GAT equal or above 15 mmHg prior performance of self-tonometry with iCare Home Receives: Other: Unchanged treatment; Other: Changed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician's choice of glaucoma treatment
Type of treatment received by patient after performance of self-tonometry with iCare Home
Measured: One month
Secondary outcomes (1)
Occurence of IOP peaks
Occurence of IOP peaks measured by self-tonometry
Measured: Three days of self-tonometry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start10 May 2021
- Primary completion30 Nov 2021
- Study completion1 Feb 2022
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 133 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 PhD, Principal investigator, St. Erik Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888156
- Sponsor's protocol ID
- iCare Home
- Status last verified
- Mar 2022
- First submitted
- 11 May 2021
- Last updated
- 16 Mar 2022
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Self-tonometry With iCare Home ® on Glaucoma Treatment Decision.
- ClinicalTrials.gov ID
- NCT04888156
- Acronym / sponsor ID
- iCare Home
- Keywords
- glaucoma, self-tonometry, treatment, IOP peaks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- St. Erik Eye HospitalUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 17 May 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 performed by one hundred patients annually at Sankt Erik's Eye Hospital. The investigators want to evaluate the impact that self-tonometry results have on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours.
Detailed description
Since a few years back, self-tonometry has been available in glaucoma care. Self-tonometry allows patients to measure their eye pressure themselves using a portable tonometer. Sankt Erik's Eye Hospital was the first healthcare provider in Sweden to use this new technology. The investigators have previously conducted studies that have shown good agreement between the measurements made by patients and the gold standard method, e.g. Goldman applanation tonometry (GAT) (Chen, Querat et al. 2016, Querat and Chen 2017). About one hundred patients perform pressure curves with self-tonometry annually.
As the method is used regularly, the investigators want to evaluate the impact of self-tonometry results on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours and how much they differ from GAT.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAT IOP below 15 mmHg | – | Other: Unchanged treatment, Other: Changed treatmentGlaucoma patients with an IOP measured with GAT below 15 mmHg prior performance of self-tonometry with iCare Home |
| GAT IOP equal or above 15 mmHg | – | Other: Unchanged treatment, Other: Changed treatmentGlaucoma patients with an IOP measured with GAT equal or above 15 mmHg prior performance of self-tonometry with iCare Home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All glaucoma patients who obtained an IOP curve using an iCare Home® self-tonometer between January 2018 and December 2020 and who fulfill all the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Diagnosed with POAG (primary open-angle glaucoma), PEX (pseudo-exfoliation glaucoma) or OHT (ocular hypertension)
- Difference between patients' and staff's iCare Home® measurements less than 5 mmHg at Baseline
- Difference between Goldman Applanation tonometry (GAT) and patient's highest iCare Home® measurements less than 7 mmHg at baseline
- Monitoring over at least two days
Key exclusion criteria (2 listed)
- More than one measurement with iCare Home® tonometer below 5 mmHg
- Missing more than one daily measurement with iCare Home® tonometer
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 |
|---|---|---|
| Unchanged treatmentTreatment is the same pre- and post self-tonometry | Other | GAT IOP below 15 mmHg, GAT IOP equal or above 15 mmHg |
| Changed treatmentTreatment is changed post self-tonometry | Other | GAT IOP below 15 mmHg, GAT IOP equal or above 15 mmHg |
Primary outcome
Clinician's choice of glaucoma treatment
Time frame: One month
Type of treatment received by patient after performance of self-tonometry with iCare Home
1 secondary outcome
Occurence of IOP peaks
Time frame: Three days of self-tonometry
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 16 Mar 2022.
- 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 PhD 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 Glaucoma, Open-Angle, 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 5 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 16 Mar 2022. 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?
Clinician's choice of glaucoma treatment (time frame: One month). 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 16 Mar 2022.