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OpenTrials
Completed

NCT Number: NCT03057301

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.

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Key information

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Alexandra Eye Pavilion

Edinburgh, Midlothian, EH39HA, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

iCare home tonometer

Device

All subjects will be taught to use the home care tonometer.

Primary outcomes

  1. Whether or not the subject is deemed successful in using the home tonometer

    Time frame: On baseline visit

    Strict success = intraocular pressure within 5mmHg of that obtained by technician

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 20, 2017
Registry last updated
Nov 15, 2024

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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