Assessment of Home Tonometry in Glaucoma

Worldwide, glaucoma is the most common cause of irreversible blindness. The major risk factor is raised pressure within the eye (intraocular pressure, IOP). IOP is typically measured using Goldman applanation tonometry (GAT). This involves instilling anaesthetic eye drops and using a probe to contact the cornea and obtain a pressure measurement. A major disadvantage of GAT is that only limited numbers of pressure measurements can be obtained, whereas IOP is known to vary throughout the day and in ¾ of people is highest during the night. The result is that clinicians have poor understanding of patient's 24 hour IOPs and the effect that this might have on their glaucoma. This is a serious limitation as the treatment of glaucoma depends on lowering IOP.

Recently a new device has become available, designed specifically for home IOP monitoring. The iCare HOME tonometer is a CE marked commercial device (http://www.icaretonometer.com/products/icare-home-tonometer/) that can be used to gain insight into 24-hour IOP fluctuations. The investigators wish to determine the feasibility of home IOP monitoring using this device. The iCare HOME tonometer depends on the patient performing self-tonometry. Testing one's own IOP may be technically difficult and it is likely that large numbers of patients will struggle with this.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Intraocular Pressure
• Intervention / Treatment: Device: iCare home tonometer

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United Kingdom
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH39HA
      • Princess Alexandra Eye Pavilion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 96 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with glaucoma attending a university hospital glaucoma clinic.

Description

Inclusion Criteria:

• Glaucoma
• At least 4 previous visual field tests (to enable rate of change to be calculated).
• Age 16 years and above
• Age less than 100

Exclusion Criteria:

• Corneal disease (potentially affects pressure measurements)
• Neovascular glaucoma
• Uveitis
• Secondary glaucomas
• Inability to give informed consent.
• Less than 16 years of age.
• Pregnancy.
• Unable to hold iCare HOME® tonometer due to upper limb weakness or disability.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whether or not the subject is deemed successful in using the home tonometer	Strict success = intraocular pressure within 5mmHg of that obtained by technician	On baseline visit

Collaborators and Investigators

• Sponsor: NHS Lothian
• Investigators: Principal Investigator: Andrew J Tatham, FRCOphth, NHS Lothian

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): May 17, 2017
• Study Completion (Actual): May 17, 2017

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: AC16040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No