Assessment of Home Tonometry in Glaucoma

Glaucoma Clinical Trial

Official title:

Assessment of Home Tonometry in Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03057301
• Other study ID #: AC16040
• Status: Recruiting
• Phase: N/A
• First received: February 15, 2017
• Last updated: February 15, 2017
• Start date: April 1, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: February 2017
• Source: NHS Lothian
• Contact: Margaret McDonald
• Phone: 441315363902
• Email: margaret.l.macdonald[@]nhslothian.scot.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. We 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Intraocular Pressure

Intervention

Device:
• iCare home tonometer
All subjects will be taught to use the home care tonometer.

Locations

Country	Name	City	State
United Kingdom	Princess Alexandra Eye Pavilion	Edinburgh	Midlothian

Sponsors (1)

Lead Sponsor	Collaborator
NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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