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Completed

NCT Number: NCT02656836

Home Tonometry With the I-care Tonometer for Glaucoma

The overall objective of the study is to scope the self-management for self-monitoring glaucoma using home tonometry.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Experimental Medicine QUB

Belfast, Co.Antrim, BT12 6BA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Attending the glaucoma clinic for monitoring (for glaucoma or ocular hypertension)
  • Aged 18 years or over
  • Patient deemed able to monitor their IOP at home (by themselves or a helper)

Exclusion criteria

  • Not receiving IOP monitoring (for glaucoma or ocular hypertension)
  • Aged <18 years
  • 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
  • Had surgery for their glaucoma (glaucoma surgery only; other surgeries included e.g., cataract surgery)
  • Patient has preexisting corneal disease

Treatment and study plan

Home tonometry, diagnostic study

Other

Evaluating intraocular pressure

Other names: I-care tonometer

Primary outcomes

  1. Intraocular Pressure

    Time frame: 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 outcomes

  1. Proportion of Patients Able and Willing to Use the Tonometer

    Time frame: Two weeks

    Proportion of patients willing to use the tonometer but are unable to. Patient feedback reported via questionnaire

  2. Proportion of Patients With an Adverse Event

    Time frame: One month

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

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Belfast Health and Social Care Trust

Registry information

Official study title

Home Tonometry for Monitoring Glaucoma:a Pilot Study of the Icare Home Tonometer

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2016
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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