[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511529":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":33,"studyPopulation":11,"armGroups":34,"interventions":46,"overallOfficials":57,"centralContacts":61,"locations":69,"responsibleParty":82,"collaborators":85,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":11,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":11,"enrollmentInfo":98,"targetDuration":11,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":72,"whyStopped":11,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"IOP levels over the study period",null,"From baseline to 30 months",[14,16,18],{"measure":15,"description":11,"timeFrame":12},"Rates of change of global, superotemporal and inferotemporal RNFL thicknesses.",{"measure":17,"description":11,"timeFrame":12},"Rates of change of average and regional GCIPL thicknesses",{"measure":19,"description":20,"timeFrame":12},"Visual field progression","Visual field progression defined with reference to the EMGT criteria",[22,24],{"measure":23,"description":11,"timeFrame":12},"Number of IOP-lowering medications",{"measure":25,"description":11,"timeFrame":12},"Agreement of IOP measurements between GAT and iCare",{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":11,"timePerspective":11,"maskingInfo":31},"RANDOMIZED","PARALLEL","iCare Home2 tonometer","SUPPORTIVE_CARE",{"masking":32,"maskingDescription":11,"whoMasked":11},"NONE","Study design This is a 30-month prospective, multicenter, randomized clinical trial to compare the treatment outcomes between two management paradigms: (I) home IOP telemonitoring combined with smart phone-based intervention, and (II) standard care plus smart phone- based intervention, in 142 patients with newly diagnosed primary open-angle glaucoma (POAG). Both management paradigms aim to decrease the IOP by the same degree according to the disease severity. For mild to moderate glaucoma (visual field MD ≥ -12 dB), we aim to decrease the IOP by at least 20% from the baseline (methods of baseline IOP measurements are described below) targeting the IOP levels \\\u003C21 mmHg; for advanced glaucoma (visual field MD \\\u003C-12 dB), we aim to decease the IOP by at least 25% from the baseline targeting the IOP levels \\\u003C15 millimeters of mercury (mmHg). The unit of observation for sample size estimation and randomization will be based on subject. Patients will be randomized by minimization, stratified by demographics (age, gender, and axial length) and clinical parameters (baseline IOP levels and baseline RNFL thickness of the better eye). For analysis of outcome measures, both eyes will be included if both eyes are eligible for inclusion (described below), taking account for clustering between fellow eyes. Intent-to-treat analyses will be performed. The primary outcome measure will be clinic-measured GAT measurements collected at 3-month intervals over 30 months of study follow-up. The secondary outcome measures include the rates of change of global, superotemporal and inferotemporal RNFL thicknesses, and the rates of change of global and regional GCIPL thicknesses. 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\u002FGCIPL thinning would be slower for those randomized to Management Paradigm I compared with those randomized to Management Paradigm II. Additional analyses include (i) comparisons of visual field (VF) survival probabilities (defined by the Early Manifest Glaucoma Trial (EMGT) criteria) and (ii) the number of ocular hypotensive medications between the treatment groups during the study follow-up; and (iii) investigation of risk factors associated with the rate of RNFL\u002FGCIPL thinning including mean IOP (measured by iCare Home or GAT), long-term IOP fluctuations (IOP deviated from the mean during study follow-up), and glaucoma severity (baseline average RNFL thickness). Study safety endpoints will include: (i) visual field (VF) progression; (ii) decrease in visual acuity (VA) ≥2 lines; and (iii) IOP≥35mmHg on 2 consecutive visits. Patients will exit the study and receive additional treatment(s) if any of the study safety endpoints is reached. Patients randomized to have IOP measured by iCare Home will continue the home IOP measurements until the completion of study. All patients in Management Paradigms I and II will be followed up 3-monthly in the clinic for GAT, optical coherence tomography retinal nerve fiber layer (OCT RNFL) imaging and perimetry.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Management Paradigm I: Home IOP telemonitoring with smart phone-based intervention","ACTIVE_COMPARATOR","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.\n\nInvestigators 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.\n\nEvery 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.",[40],"Device: Home IOP telemonitoring with smart phone-based intervention",{"label":42,"type":37,"description":43,"interventionNames":44},"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\u002Ffunctional assessments.\n\nEvery 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.",[45],"Behavioral: Standard care and smart phone-based intervention",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":11},"DEVICE","Home IOP telemonitoring with smart phone-based intervention","Participants use the iCare HOME rebound tonometer to perform self-measurements of intraocular pressure at home for 30 months.\n\nAfter 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.",[36],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":11},"BEHAVIORAL","Standard care and smart phone-based intervention","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.",[42],[58],{"name":59,"affiliation":5,"role":60},"Christopher Leung","PRINCIPAL_INVESTIGATOR",[62,66],{"name":59,"role":63,"phone":64,"phoneExt":11,"email":65},"CONTACT","39102673","cleung21@hku.hk",{"name":67,"role":63,"phone":64,"phoneExt":11,"email":68},"Anita Yau","anitayky@hku.hk",[70],{"facility":71,"status":72,"city":73,"state":11,"zip":11,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":11},"HKU Eye Centre","RECRUITING","Wong Chuk Hang","Hong Kong","HK",{"type":77,"coordinates":78},"Point",[79,80],114.17001,22.23981,{"lat":80,"lon":79},{"type":60,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Professor Christopher K.S. Leung","Clinical Professor",[86],{"name":87,"class":88},"Icare Finland Oy","INDUSTRY","100511529","impact-of-home-intraocular-pressure-telemonitoring-on-intraocular-pressure-control-and-glaucoma-progression-100511529",false,"NCT05940623","Impact of Home Intraocular Pressure Telemonitoring on Intraocular Pressure Control and Glaucoma Progression","Impact of Home Intraocular Pressure Telemonitoring on Intraocular Pressure Control and Glaucoma Progression - A Randomized Control Trial","Inclusion Criteria:\n\n* Newly diagnosed primary open-angle glaucoma (POAG)\n* Best corrected visual acuity (VA) ≥20\u002F40 for the included eye(s)\n\nExclusion Criteria:\n\n* IOP \\>35 millimeters of mercury (mmHg)\n* Dry eye syndrome\n* Central corneal thickness \\\u003C500μm or \\>600μm\n* Failure to complete the iCare Home certification procedure at the baseline visits\n* Only one eye with functional vision\n* Inability to perform reliable visual field (VF)\n* Pathological myopia (eyes with axial length≥26mm with lacquer cracks and chorioretinal atrophy)\n* Suboptimal quality of optical coherence tomography (OCT) images (described below in RNFL imaging)\n* Previous intraocular surgery or corneal refractive surgery other than uncomplicated cataract extraction\n* Diabetic retinopathy\u002Fmaculopathy","ALL","18 Years",{"count":99,"type":100},142,"ESTIMATED","INTERVENTIONAL",[103],"NA","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.\n\nIt aims to:\n\nto 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.\n\nParticipants will asked to do,\n\n* 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.\n* Management paradigm II: Patients will be treated with a topical prostaglandin analogue after baseline intra-ocular pressure (IOP) measurements.",[106,107,108],"Glaucoma","Intraocular Pressure","Primary Open Angle Glaucoma",[110,106],"Ophthalmology","2026-08-31",{"date":113,"type":114},"2026-09-03","ACTUAL",{"date":116,"type":114},"2025-09-18",{"date":118,"type":100},"2028-06-30",{"name":5,"class":6},1]