Clinical trial NCT02656836: Home Tonometry With the I-care Tonometer for Glaucoma
Official title: Home Tonometry for Monitoring Glaucoma:a Pilot Study of the Icare Home Tonometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
First posted: 2016-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with glaucoma attending clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraocular Pressure
timeFrame: Two weeks
Secondary outcomes:
measure: Proportion of Patients Able and Willing to Use the Tonometer
timeFrame: Two weeks
measure: Proportion of Patients With an Adverse Event
timeFrame: One month
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Centre for Experimental Medicine QUB
state: Co.Antrim
Study officials:
affiliation: Queen's University, Belfast
name: Augusto Azuara-Blanco
role: PRINCIPAL_INVESTIGATOR
References: