Home Tonometry With the I-care Tonometer for Glaucoma

NCT ID: NCT02656836

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-04-30

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.

Conditions

Glaucoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Home tonometry, diagnostic study

Evaluating intraocular pressure

Intervention Type: OTHER

Other Intervention Names

I-care tonometer

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belfast Health and Social Care Trust

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Professor Augusto Azuara-Blanco

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Augusto Azuara-Blanco

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Centre for Experimental Medicine QUB

Belfast, Co.Antrim, United Kingdom

Countries

United Kingdom

Other Identifiers

REC 15/EM/0217

Identifier Type: -

Identifier Source: org_study_id