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Impact of Home Intraocular Pressure Telemonitoring on Intraocular Pressure Control and Glaucoma Progression - A Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Newly diagnosed primary open-angle glaucoma (POAG)

• Best corrected visual acuity (VA) ≥20/40 for the included eye(s)

Locations
Other Locations
Hong Kong Special Administrative Region
HKU Eye Centre
RECRUITING
Wong Chuk Hang
Contact Information
Primary
Christopher Leung
cleung21@hku.hk
39102673
Backup
Anita Yau
anitayky@hku.hk
39102673
Time Frame
Start Date: 2025-09-18
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 142
Treatments
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.
Sponsors
Collaborators: Icare Finland Oy
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov