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

ConditionsGlaucoma Intraocular Pressure Primary Open Angle Glaucoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe University of Hong Kong

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed primary open-angle glaucoma (POAG)

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

Disqualifiers

IOP >35 millimeters of mercury (mmHg)

Dry eye syndrome

Central corneal thickness <500μm or >600μm

Failure to complete the iCare Home certification procedure at the baseline visits

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

142 Participants

are divided into 2 treatment groups

Group A: Management Paradigm I: Home IOP telemonitoring with smart phone-based interventionActive comparator 1 intervention

Group B: Management paradigm II: Standard care and smart phone-based interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

IOP levels over the study period

Time frame

From baseline to 30 months

Secondary outcomes

Rates of change of global, superotemporal and inferotemporal RNFL thicknesses.

Time frame

From baseline to 30 months

Rates of change of average and regional GCIPL thicknesses

Time frame

From baseline to 30 months

Visual field progression

Visual field progression defined with reference to the EMGT criteria

Time frame

From baseline to 30 months

Other outcomes

Number of IOP-lowering medications

Time frame

From baseline to 30 months

Agreement of IOP measurements between GAT and iCare

Time frame

From baseline to 30 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Icare Finland Oy

Collaborator

Source ClinicalTrials.gov

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