Glaucoma
Conditions
Brief summary
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.
Interventions
OTHERHome tonometry, diagnostic study
Evaluating intraocular pressure
Sponsors
Belfast Health and Social Care Trust
Queen's University, Belfast
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Attending the glaucoma clinic for monitoring (for glaucoma or ocular hypertension) 2. Aged 18 years or over 3. Patient deemed able to monitor their IOP at home (by themselves or a helper)
Exclusion criteria
1. Not receiving IOP monitoring (for glaucoma or ocular hypertension) 2. Aged \<18 years 3. 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 4. Had surgery for their glaucoma (glaucoma surgery only; other surgeries included e.g., cataract surgery) 5. Patient has preexisting corneal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Able and Willing to Use the Tonometer | Two weeks | Proportion of patients willing to use the tonometer but are unable to. Patient feedback reported via questionnaire |
| Proportion of Patients With an Adverse Event | One month | Any adverse event or complication associated with the use of the device. Expected side effects will be corneal erosion, and ocular irritation. |
Countries
United Kingdom
Participant flow
Recruitment details
Could not recruit target number of participants within the time frame
Participants by arm
| Arm | Count |
|---|---|
| Home Tonometry Group No comparator | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Home Tonometry Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United Kingdom | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: Two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Tonometry Group | Intraocular Pressure | -1.85 mmHg | Standard Deviation 3.95 |
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
Time frame: Two weeks
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.
Time frame: One month