Impact of Home Intraocular Pressure Telemonitoring on Intraocular Pressure Control and Glaucoma Progression

Sponsor
The University of Hong Kong
Study ID
NCT05940623
Status
Recruiting
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Conditions

  • Glaucoma
  • Intraocular Pressure
  • Primary Open Angle Glaucoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Home IOP telemonitoring with smart phone-based intervention — DEVICE
    Participants use the iCare HOME rebound tonometer to perform self-measurements of intraocular pressure at home for 30 months. After a 4-week baseline period with at least 24 measurements (early morning supine and sitting, mid-day, and evening on different days), patients continue to obtain at least six IOP measurements per week and upload readings to the secure iCare CLINIC cloud system. Investigators review home IOP profiles every 4 weeks and use a predefined algorithm to determine whether treatment goals are met and whether glaucoma therapy should be intensified.
  • Standard care and smart phone-based intervention — BEHAVIORAL
    Every 4 weeks, participants receive automated or investigator-generated smartphone text messages summarizing whether their individualized target intraocular pressure has been achieved and reminding them to adhere to prescribed eye-drop therapy. In Management Paradigm I, the feedback is based on home IOP readings from the iCare HOME device, whereas in Management Paradigm II it is based on the most recent clinic Goldmann applanation measurement. Participants reply by text with the number of missed eye-drop doses over the past 4 weeks, and clinic staff contact patients by telephone when replies or monitoring data are insufficient.

Study Details

The goal of this clinical trial is to conduct a study randomizing glaucoma patients to home intra-ocular pressure (IOP) telemonitoring combined with Smart phone-based intervention (Management Paradigm I) or Smart phone-based intervention alone (Management Paradigm II), with the objectives to compare (1) Goldmann applanation tonometry (GAT) intra-ocular pressure (IOP) measurements over the entire study period (primary outcome measure) and (2) the rates of Retinal nerve fiber layer (RNFL) thinning (secondary outcome measure) between the two Management Paradigms. We hypothesize that glaucoma patients randomized to Management Paradigm I will (1) attain lower levels of intra-ocular pressure (IOP), and (2) a slower rate of Retinal nerve fiber layer (RNFL) and ganglion cell inner plexiform layer (GCIPL) thinning compared with those randomized to Management Paradigm II because of having a more precise assessment of intra-ocular pressure (IOP) to guide intra-ocular pressure (IOP)- lowering therapy would be feasible in Management Paradigm I. It aims to: to compare (1) Goldmann applanation tonometry (GAT) intra-ocular pressure (IOP) measurements over the entire study period (primary outcome measure) and (2) the rates of Retinal Nerve Fiber Layer (RNFL) thinning (secondary outcome measure) between the two Management Paradigms. Participants will asked to do, * Management Paradigm I: will be provided with an iCare Home and instructed to measure and upload 6 intra-ocular pressure (IOP) measurements weekly (2 days a week, 1 measurement in the early morning (5 am to 9 am), 1 during the mid-day (12 pm to 4 pm) and 1 in the evening (7 pm to 11pm)) to a secure server via iCare CLINIC (the number of weekly intra-ocular pressure (IOP) measurements follows the number of weekly blood pressure measurements in the HyperLink study). The morning measurement will include two readings with the first obtained in the supine position before getting out of the bed and the second obtained in the upright position right after. Patients may take additional intra-ocular pressure (IOP) measurements in supine position if they wake up in bed from sleep, as well as other times of the day, but this is not mandatory. These additional intra-ocular pressure (IOP) measurements will not be included for treatment decisions during the study period. * Management paradigm II: Patients will be treated with a topical prostaglandin analogue after baseline intra-ocular pressure (IOP) measurements.

Key Dates

First listed
Jul 11, 2023
Start date
Sep 18, 2025
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Management Paradigm I: Home IOP telemonitoring with smart phone-based intervention
    Before treatment initiation, patients perform 4 weeks of baseline home IOP measurements, then continue to obtain at least six IOP measurements per week (two readings in the early morning, and one each at mid-day and evening on two days per week) and upload readings via the iCare CLINIC cloud platform. Investigators review home IOP data every 4 weeks and adjust topical IOP-lowering therapy according to a predefined algorithm whenever fewer than 75% of home readings are below the target IOP based on disease severity. Every 4 weeks, patients receive smartphone text messages indicating whether the home-based target IOP has been achieved and reminding them about eye-drop adherence; patients report missed doses by text, and a nurse calls patients who do not reply or who submit fewer than 20 home IOP readings in 4 weeks.
  • Active Comparator: Management paradigm II: Standard care and smart phone-based intervention
    Topical IOP-lowering therapy is escalated according to the same predefined stepwise protocol used in Management Paradigm I when target IOP is not reached. No home IOP telemonitoring is used; treatment decisions rely on clinic-measured IOP and structural/functional assessments. Every 4 weeks, patients receive smartphone text messages indicating whether the target pressure has been attained based on the latest clinic Goldmann measurement and reminding them about eye-drop adherence; patients report missed doses by text, and clinic staff follow up by phone as needed.

Primary Outcome Measure

IOP levels over the study period [ Time Frame: From baseline to 30 months ]

Central Contacts

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