Home Tonometry With the I-care Tonometer for Glaucoma

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Other: Home tonometry, diagnostic study

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Co.Antrim
    • Belfast, Co.Antrim, United Kingdom, BT12 6BA
      • Centre for Experimental Medicine QUB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with glaucoma attending clinic

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Any adverse event or complication associated with the use of the device. Expected side effects will be corneal erosion, and ocular irritation.	One month

Collaborators and Investigators

• Sponsor: Queen's University, Belfast
• Collaborators: Belfast Health and Social Care Trust
• Investigators: Principal Investigator: Augusto Azuara-Blanco, Queen's University, Belfast

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: REC 15/EM/0217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED