GlaucomaNCT02656836
Home Tonometry With the I-care Tonometer for Glaucoma
An observational study of Glaucoma, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
The overall objective of the study is to scope the self-management for self-monitoring glaucoma using home tonometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Home tonometry, diagnostic study
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to Apr 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Adults with glaucoma attending clinic
Who may be able to join
- Attending the glaucoma clinic for monitoring (for glaucoma or ocular hypertension)
- Aged 18 years or over
- Patient deemed able to monitor their IOP at home (by themselves or a helper)
Who cannot join
- Not receiving IOP monitoring (for glaucoma or ocular hypertension)
- Aged <18 years
- Patients deemed unable to monitor their IOP at home (and do not have someone who can help them) e.g., apparent physical or cognitive impairments that will not allow for the use of a home tonometer
- Had surgery for their glaucoma (glaucoma surgery only; other surgeries included e.g., cataract surgery)
- Patient has preexisting corneal disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Experimental Medicine QUB
Belfast, Co.Antrim, BT12 6BA
About this study
Official title: Home Tonometry for Monitoring Glaucoma:a Pilot Study of the Icare Home Tonometer
The overall objective of the study is to scope the self-management for self-monitoring glaucoma using home tonometry.
Read the detailed description
Monitoring of glaucoma requires frequent evaluation of IOP and disease severity, typically with visual field tests. When a patient is diagnosed with glaucoma an optimum level of IOP (or target IOP) is determined based on patient's characteristics, such as severity of disease and life expectancy. In current models of care patients have their IOP measured at the clinic at different intervals. If the IOP is noted to be high, or above the patient's target, additional treatment is recommended. Accurate and frequent IOP measurements at different points in time are thus imperative.
Tonometry is usually conducted by clinicians in an eye clinic. Some tonometers (e.g., Icare) have the potential to be used by the individual for home monitoring of IOP for patients with suspected glaucoma/glaucoma. Self-monitoring of IOP via home tonometry will allow patients to undergo IOP measurements at different points in time (e.g., early morning and night-time, and it can help determine diurnal changes and spikes).
The overall objective of the current study is to conduct a feasibility pilot study on the home tonometer (Icare), acquiring initial experience with the Icare tonometer. For this purpose investigators will train up to 20 individuals on how to use the device. Investigators will ask them to record in a diary their IOP twice a day for a period of 2 weeks. Investigators will then compare IOP outcomes with the measurement taken at the clinic. Patients and clinicians will be masked to the IOP data.
- Conditions
- Glaucoma
- Being tested
- Home tonometry, diagnostic study
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home tonometry, diagnostic studyOther
Also called I-care tonometer
Evaluating intraocular pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
Intraocular pressure in mmHg units, obtained by tonometers. The investigators will determine agreement of intraocular pressure (IOP) measured using the home tonometer (patient) compared with IOP measured in the clinic.
Measured: Two weeks
Secondary outcomes (2)
Proportion of Patients Able and Willing to Use the Tonometer
Proportion of patients willing to use the tonometer but are unable to. Patient feedback reported via questionnaire
Measured: Two weeks
Proportion of Patients With an Adverse Event
Any adverse event or complication associated with the use of the device. Expected side effects will be corneal erosion, and ocular irritation.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Responsible party
- Principal investigator, Professor Augusto Azuara-Blanco, Queen's University, Belfast
- Investigators
- Augusto Azuara-Blanco, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656836
- Sponsor's protocol ID
- REC 15/EM/0217
- Status last verified
- Jan 2020
- First submitted
- 11 Jan 2016
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Tonometry for Monitoring Glaucoma:a Pilot Study of the Icare Home Tonometer
- ClinicalTrials.gov ID
- NCT02656836
- Acronym / sponsor ID
- REC 15/EM/0217
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the study is to scope the self-management for self-monitoring glaucoma using home tonometry.
Detailed description
Monitoring of glaucoma requires frequent evaluation of IOP and disease severity, typically with visual field tests. When a patient is diagnosed with glaucoma an optimum level of IOP (or target IOP) is determined based on patient's characteristics, such as severity of disease and life expectancy. In current models of care patients have their IOP measured at the clinic at different intervals. If the IOP is noted to be high, or above the patient's target, additional treatment is recommended. Accurate and frequent IOP measurements at different points in time are thus imperative.
Tonometry is usually conducted by clinicians in an eye clinic. Some tonometers (e.g., Icare) have the potential to be used by the individual for home monitoring of IOP for patients with suspected glaucoma/glaucoma. Self-monitoring of IOP via home tonometry will allow patients to undergo IOP measurements at different points in time (e.g., early morning and night-time, and it can help determine diurnal changes and spikes).
The overall objective of the current study is to conduct a feasibility pilot study on the home tonometer (Icare), acquiring initial experience with the Icare tonometer. For this purpose investigators will train up to 20 individuals on how to use the device. Investigators will ask them to record in a diary their IOP twice a day for a period of 2 weeks. Investigators will then compare IOP outcomes with the measurement taken at the clinic. Patients and clinicians will be masked to the IOP data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with glaucoma attending clinic
Key inclusion criteria (3 listed)
- Attending the glaucoma clinic for monitoring (for glaucoma or ocular hypertension)
- Aged 18 years or over
- Patient deemed able to monitor their IOP at home (by themselves or a helper)
Key exclusion criteria (5 listed)
- Not receiving IOP monitoring (for glaucoma or ocular hypertension)
- Aged <18 years
- Patients deemed unable to monitor their IOP at home (and do not have someone who can help them) e.g., apparent physical or cognitive impairments that will not allow for the use of a home tonometer
- Had surgery for their glaucoma (glaucoma surgery only; other surgeries included e.g., cataract surgery)
- Patient has preexisting corneal disease
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 |
|---|---|---|
| Home tonometry, diagnostic studyAlso: I-care tonometerEvaluating intraocular pressure | Other | – |
Primary outcome
Intraocular Pressure
Time frame: Two weeks
Intraocular pressure in mmHg units, obtained by tonometers. The investigators will determine agreement of intraocular pressure (IOP) measured using the home tonometer (patient) compared with IOP measured in the clinic.
2 secondary outcomes
Proportion of Patients Able and Willing to Use the Tonometer
Time frame: Two weeks
Proportion of Patients With an Adverse Event
Time frame: One month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Augusto Azuara-Blanco principal investigator
Queen's University, Belfast
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, run by Queen's University, Belfast at 1 site in United Kingdom.
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 3 inclusion and 5 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 5 Feb 2020. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraocular Pressure (time frame: Two weeks). 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 5 Feb 2020.