Evaluating the Icare-HOME tonometer for patient self-monitoring of eye pressure to optimise glaucoma management

Not Applicable

Completed

• Conditions: Glaucoma; Eye - Diseases / disorders of the eye; Eye - Normal eye development and function; Public Health - Health promotion/education

• Registration Number: ACTRN12615001274561
• Lead Sponsor: Dr. Barbara Zangerl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Diagnosis of ‘glaucoma suspect’, including those being followed for elevated IOP, for risk factors for developing glaucoma, or for possible optic nerve damage.
-Diagnosis of ‘glaucoma’ where there is either confirmed optic nerve damage and/or visual field loss consistent with glaucomatous optic neuropathy.

Exclusion Criteria

-Uncorrected near visual acuity of 6/60 (N24) or worse
-Only one functional eye
-Poor or eccentric fixation in the study eye(s)
-Hearing impaired to the extent that the individual cannot hear and converse with others without an assistance aid and/or sign language
-High corneal astigmatism >3D in the study eye(s) based on autokeratometry
-Disabling arthritis or limited motor coordination limiting self-handling of the ICARE HOME tonometer
-Lack of comprehension or willingness to use the tonometer as instructed
-Corneal scarring
-History of prior incisional glaucoma surgery or cornea surgery, including corneal laser surgery
-Microphthalmos
-Buphthalmos
-Contact lens use
-Symptoms of dry eye syndrome and signs of dry eye on examination of the cornea
-Known history of difficulty in obtaining Goldmann IOP measurements or any factors that might contribute to inaccurate Goldmann IOP measurements (e.g. lid squeezing or tremor)
-Nystagmus
-Keratoconus
-Any other corneal or conjunctival pathology or infection
-Inability to demonstrate proficiency with ICARE HOME tonometer after training and failure to complete certification procedures
-Cataract extraction within the last two months in the study eye(s)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra-ocular pressure (IOP) measured with the ICARE HOME device in the home environment in comparison to in-clinic measurements with traditional applanation tonometry.<br>[6 weeks past study enrollment];Effect of self-monitored IOP measurements on management decisions; Confirmation or adjustment of patient management will be determined during the follow-up visit and recorded before data from the ICARE HOME device are being made available to the clinician. Effect of the ICARE HOME IOP measurements will be recorded as any change in the decision after the data has been disclosed.[6 weeks past study enrollment]

Secondary Outcome Measures

Name	Time	Method
Compliance of the subjects with regards to using the ICARE HOME device. Compliance will be determined from date/time points automatically recorded by the ICARE HOME device.[6 weeks past study enrollment];Satisfaction of the subjects with regards to using the ICARE HOME device; Satisfaction of all participants will be determined with a modified PSQ-18 form to address care related to the ICARE HOME device included for the study group.[6 weeks past study enrollment]