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

RecruitingNAAges 18 Years - anyAllThe University of Hong Kong
NCT05940623 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
Inclusion Criteria: * Newly diagnosed primary open-angle glaucoma (POAG) * Best corrected visual acuity (VA) ≥20/40 for the included eye(s) Exclusion Criteria: * 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
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What it tests

  • Home IOP telemonitoring with smart phone-based intervention
  • Standard care and smart phone-based intervention
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Where

1 site
HKU Eye Centre
Wong Chuk Hang, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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