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

NCT05940623 | Unknown

• 1 other identifier: Protocol_iCare_v2_20230523
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glaucoma; Intraocular Pressure; Primary Open Angle Glaucoma

Keywords

Ophthalmology; Glaucoma

Outcome Measures

Primary Outcomes (1)

• Clinic-measured Goldmann applanation tonometry measurements collected at 3-month interval over 30 months of study follow-up.

  Goldmann applanation tonometry is an instrument measures intra-ocular pressure based on Imbert-Fick law. The Goldmann equation states: Po = (F/C) + Pv \[Po is the IOP in millimeters of mercury (mmHg), F is the rate of aqueous formation, C is the facility of outflow, and Pv is the episcleral venous pressure\].

  From baseline to 30 months, at 3-month intervals

Secondary Outcomes (1)

• Rate of changes of global, superotemporal and inferotemporal Retinal Nerve Fiber Layer (RNFL) thickness, and the rate of changes of global and regional Ganglion cell-inner plexiform layer (GCIPL) thickness.

  From baseline to 30 months, at 3-month intervals

Study Arms (2)

Management Paradigm I: Standard care and home IOP telemonitoring with smart phone-based intervention

ACTIVE COMPARATOR

Eligible patients randomized to Management Paradigm I will be provided with an iCare Home and instructed to measure and upload 6 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. Patients will be treated with topical prostaglandin analogue after baseline IOP measurements. A text message will be sent to the patient's smart phone to (1) inform whether the treatment goal is achieved over the past 4 weeks (i.e., ≥75% of the self- measured IOP measurements are below the target IOP) and (2) remind adherence to medications. The patients will need to reply via a text message reporting how many times eyedrops are missed over the past 4 weeks. A nurse will phone the patient if a reply message is not received or the number of home IOP measurements is less than 20 over the past 4 weeks.

Device: Standard care and home IOP telemonitoring with smart phone-based intervention

Management paradigm II: Standard care and smart phone-based intervention

NO INTERVENTION

Patients will be treated with a topical prostaglandin analogue after baseline IOP measurements (described below). Additional treatment will be provided in the following order: carbonic anhydrase inhibitor, brimonidine, beta blocker, and selective laser trabeculoplasty (SLT) when the target IOP is not achieved. Fixed combination will be given whenever possible to improve adherence. Similar to Management Paradigm I, smart phone-based intervention includes (1) a text message from the investigators to inform whether the target pressure is attained (with reference to the latest clinic GAT measurement) and remind medication adherence every 4 weeks and (2) a reply message from the patients regarding how many times eyedrops are missed over the past 4 weeks.

Interventions

Standard care and home IOP telemonitoring with smart phone-based intervention DEVICE

We expect that (1) GAT measurements over 30 months of follow-up for patients randomized to Management Paradigm I to be smaller compared with those randomized to Management Paradigm II; and that (2) the rates of RNFL/GCIPL thinning would be slower for those randomized to Management Paradigm I compared with those randomized to Management Paradigm II

Management Paradigm I: Standard care and home IOP telemonitoring with smart phone-based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed primary open-angle glaucoma (POAG)
• Best corrected visual acuity (VA) ≥20/40 for the included eye(s)

You may not qualify if:

• 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
• Only one eye with functional vision
• Inability to perform reliable visual field (VF)
• Pathological myopia (eyes with axial length≥26mm with lacquer cracks and chorioretinal atrophy)
• Suboptimal quality of optical coherence tomography (OCT) images (described below in RNFL imaging)
• Previous intraocular surgery or corneal refractive surgery other than uncomplicated cataract extraction
• Diabetic retinopathy/maculopathy

Sponsors & Collaborators

• The University of Hong Kong: lead
• Icare Finland Oy: collaborator

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Related Links

• 510(K) Summary of safety and effectiveness for iCare Home tonometer

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Christopher Leung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Leung

CONTACT

39102673; cleung21@hku.hk

Anita Yau

CONTACT

39102673; anitayky@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: iCare Home2 tonometer

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 11, 2023
• Study Start: August 24, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share