Glaucoma, Open-AngleNCT03445806
IOP Monitoring After Trabeculectomy Using iCare Home
An observational study of Glaucoma, Open-Angle and Pseudo Exfoliation Syndrome, run by St. Erik Eye Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate how much trabeculectomy influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Pseudo Exfoliation Syndrome
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 26 Feb 2018to 22 Mar 2021
- 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: Consecutive male and female patients, older than 18 y.o., at St Erik's Eye Hospital in Stockholm, Sweden, diagnosed with POAG or PXG and listed for a trabeculectomy.
Who may be able to join
- POAG
- PXG
Who cannot join
- previous trabeculectomy
- reduced hand and arm mobility (e. due to rheumatism)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate how much trabeculectomy influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).
Read the detailed description
Fifty glaucoma patients (POAG and PEX) planned for trabeculectomy will be recruited.
At baseline, patients will be trained to use the iCare Home tonometer (RTHome), a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. At the same visit, a new measurement will be obtained by the study staff, an optometrist or a nurse, using the same device. No IOP values will be visible for the examiner at that point. A single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will come for a second visit where new measurements will be made in the same way as at baseline.
In between visits, patients will borrow the iCare Home tonometer to measure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve.
Two-three months after trabeculectomy, a new IOP curve will be obtained following the same procedure as pre-operatively. There will be no restrictions in patients' daily activities regarding diet, physical activity or slee. If patients use any eyedrops, they will continue to use them as prescribed.
- Conditions
- Glaucoma, Open-Angle, Pseudo Exfoliation Syndrome
- Keywords
- IOP fluctuations, iCare Home, Trabeculectomy, self-tonometry
- Medical subject headings
- Glaucoma, Open-Angle, Exfoliation Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowering of IOP levels after trabeculectomy
Mean (SD) IOP pre- and post trabeculectomy
Measured: 2-3 months
Secondary outcomes (1)
Lowering of IOP fluctuations after trabeculectomy
Mean (SD) IOP range pre- and post trabeculectomy
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start26 Feb 2018
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
Why it stopped: Difficulty recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- 50 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445806
- Sponsor's protocol ID
- Home Trab
- Status last verified
- May 2021
- First submitted
- 15 Feb 2018
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IOP Monitoring After Trabeculectomy Using iCare Home
- ClinicalTrials.gov ID
- NCT03445806
- Acronym / sponsor ID
- Home Trab
- Conditions
- Glaucoma, Open-Angle, Pseudo Exfoliation Syndrome
- Keywords
- IOP fluctuations, iCare Home, Trabeculectomy, self-tonometry
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting patients
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Erik Eye HospitalUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 26 Feb 2018 (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 purpose of this study is to investigate how much trabeculectomy influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).
Detailed description
Fifty glaucoma patients (POAG and PEX) planned for trabeculectomy will be recruited.
At baseline, patients will be trained to use the iCare Home tonometer (RTHome), a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. At the same visit, a new measurement will be obtained by the study staff, an optometrist or a nurse, using the same device. No IOP values will be visible for the examiner at that point. A single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will come for a second visit where new measurements will be made in the same way as at baseline.
In between visits, patients will borrow the iCare Home tonometer to measure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve.
Two-three months after trabeculectomy, a new IOP curve will be obtained following the same procedure as pre-operatively. There will be no restrictions in patients' daily activities regarding diet, physical activity or slee. If patients use any eyedrops, they will continue to use them as prescribed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive male and female patients, older than 18 y.o., at St Erik's Eye Hospital in Stockholm, Sweden, diagnosed with POAG or PXG and listed for a trabeculectomy.
Key inclusion criteria (2 listed)
- POAG
- PXG
Key exclusion criteria (2 listed)
- previous trabeculectomy
- reduced hand and arm mobility (e. due to rheumatism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lowering of IOP levels after trabeculectomy
Time frame: 2-3 months
Mean (SD) IOP pre- and post trabeculectomy
1 secondary outcome
Lowering of IOP fluctuations after trabeculectomy
Time frame: 2-3 months
Results and safety
The study was stopped early (reason given: Difficulty recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
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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?
An observational study of Glaucoma, Open-Angle and Pseudo Exfoliation Syndrome, 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 2 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: stopped early, as of the sponsor's last update on 13 May 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 was stopped early (reason given: Difficulty recruiting patients). Results are not available in the source record.
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?
Lowering of IOP levels after trabeculectomy (time frame: 2-3 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 13 May 2021.