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| Name | Class |
|---|---|
| Belfast Health and Social Care Trust | OTHER |
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The overall objective of the study is to scope the self-management for self-monitoring glaucoma using home tonometry.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home tonometry, diagnostic study | Other | Evaluating intraocular pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Two weeks |
| Proportion of Patients With an Adverse Event |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with glaucoma attending clinic
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| Name | Affiliation | Role |
|---|---|---|
| Augusto Azuara-Blanco | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Experimental Medicine QUB | Belfast | Co.Antrim | BT12 6BA | United Kingdom |
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Could not recruit target number of participants within the time frame
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| ID | Title | Description |
|---|---|---|
| FG000 | Home Tonometry Group | No comparator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Home Tonometry Group | No comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mmHg | Two weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home Tonometry Group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Augusto Azuara-Blanco | Queen's University Belfast | 2890976350 | a.azuara-blanco@qub.ac.uk |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Any adverse event or complication associated with the use of the device. Expected side effects will be corneal erosion, and ocular irritation.
| One month |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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 | Not Posted | Two weeks | Participants |
| Secondary | 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. | Not Posted | One month | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
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