Assessment of Home Tonometry in Glaucoma

NCT03057301 | Completed FDA Device

• 1 other identifier: AC16040
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

iCare home tonometer DEVICE

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

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with glaucoma attending a university hospital glaucoma clinic.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

Princess Alexandra Eye Pavilion

Edinburgh, Midlothian, EH39HA, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Andrew J Tatham, FRCOphth

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: April 1, 2016
• Primary Completion: May 17, 2017
• Study Completion: May 17, 2017
• Last Updated: November 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)