Self-measurement of eye pressure to determine daily fluctuations in patients using glaucoma eye drops

Phase 4

Completed

• Conditions: Glaucoma; Intraocular pressure variability; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12618001025224
• Lead Sponsor: Dr. Barbara Zangerl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-19
• Study Completion: 2020-05-31
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Group 1: Patients, diagnosed with glaucoma or ocular hypertension who are taking topical medications to reduce intraocular pressure (prostaglandin analogue or beta-blocker)

Group 2: Patients, newly with diagnosed glaucoma or ocular hypertension who have been prescribed (but not yet started taking) a topical medication (prostaglandin analogue or beta-blocker) by the attending clinician.

Exclusion Criteria

- Known sensitivity to latanoprost or timolol eye drops
- History of breathing problems or pulmonary disease including asthma, chronic obstructive pulmonary disease
- History of heart disease involving slowed heart rate, impaired electrical conduction of the heart (i.e. sinus bradycardia, AV block) or chronic heart failure.
- Contact lens use
- Only one functional eye, poor or eccentric fixation, nystagmus
- Any corneal or conjunctival pathology or infection (keratoconus, corneal scarring, severe dry eye disease)
- History of prior incisional glaucoma surgery or cornea surgery, including corneal laser surgery
- Cataract extraction within the last two months in the study eye(s)
- Sensory or functional impairments that may limit self-handling of the ICARE HOME tonometer
- Lack of comprehension or willingness to use the tonometer as instructed

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean intra-ocular pressure (IOP) measured with the ICARE HOME device during intervention periods compared to control period[For group 1: Week 6 of the study protocol and after final appointment <br>For group 2: Weeks 4 and 8 of the study protocol and after final appointment ];Variance of IOP measured with the ICARE HOME device during intervention periods compared to control period[For group 1: Week 6 of the study protocol and after final appointment <br>For group 2: Weeks 4 and 8 of the study protocol and after final appointment ]

Secondary Outcome Measures

Name	Time	Method
Difference in mean IOP measured with the ICARE HOME device between intervention periods using a prostglandin analogue and a beta-blocker[After final appointment]