GlaucomaNCT05940623
Impact of Home Intraocular Pressure Telemonitoring on Intraocular Pressure Control and Glaucoma Progression
A study testing Home IOP telemonitoring with smart phone-based intervention in people with Glaucoma and Intraocular Pressure, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Intraocular Pressure, Primary Open Angle Glaucoma
- What is being tested?
- Home IOP telemonitoring with smart phone-based intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Sep 2025to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed primary open-angle glaucoma (POAG)
- Best corrected visual acuity (VA) ≥20/40 for the included eye(s)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Home Intraocular Pressure Telemonitoring on Intraocular Pressure Control and Glaucoma Progression - A Randomized Control 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:
Read more
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.
Read the detailed description
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 <21 mmHg; for advanced glaucoma (visual field MD <-12 dB), we aim to decease the IOP by at least 25% from the baseline targeting the IOP levels <15 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/GCIPL 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/GCIPL 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.
- Conditions
- Glaucoma, Intraocular Pressure, Primary Open Angle Glaucoma
- Being tested
- Home IOP telemonitoring with smart phone-based intervention, Standard care and smart phone-based intervention
- Keywords
- Ophthalmology, Glaucoma
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home IOP telemonitoring with smart phone-based interventionDevice
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.
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. Receives: Device: Home IOP telemonitoring with smart phone-based intervention |
| Management paradigm II: Standard care and smart phone-based intervention | Active comparator | 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. Receives: Behavioral: Standard care and smart phone-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP levels over the study period
Measured: From baseline to 30 months
Secondary outcomes (3)
Rates of change of global, superotemporal and inferotemporal RNFL thicknesses.
Measured: From baseline to 30 months
Rates of change of average and regional GCIPL thicknesses
Measured: From baseline to 30 months
Visual field progression
Visual field progression defined with reference to the EMGT criteria
Measured: From baseline to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start18 Sep 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- iCare Home2 tonometer
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Icare Finland Oy
- Responsible party
- Principal investigator, Professor Christopher K.S. Leung, The University of Hong Kong
- Investigators
- Christopher Leung, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940623
- Sponsor's protocol ID
- Protocol_iCare_v2_20230523
- Status last verified
- Aug 2026
- First submitted
- 4 Jul 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our plan is focused on publishing the analyzed results of our research through peer-review, journals and conference papers. We understand the importance of patient privacy and confidentiality. Therefore, we will not share any individual patient data with any third parties.
Publications
Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli MV, Das A, Jonas JB, Keeffe J, Kempen JH, Leasher J, Limburg H, Naidoo K, Pesudovs K, Silvester A, Stevens GA, Tahhan N, Wong TY, Taylor HR; Vision Loss Expert Group of the Global Burden of Disease Study. Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis. Lancet Glob Health. 2017 Dec;5(12):e1221-e1234. doi: 10.1016/S2214-109X(17)30393-5. Epub 2017 Oct 11.
PubMed 29032195Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PubMed 16488940Weinreb RN, Leung CK, Crowston JG, Medeiros FA, Friedman DS, Wiggs JL, Martin KR. Primary open-angle glaucoma. Nat Rev Dis Primers. 2016 Sep 22;2:16067. doi: 10.1038/nrdp.2016.67.
PubMed 27654570Liu JH, Zhang X, Kripke DF, Weinreb RN. Twenty-four-hour intraocular pressure pattern associated with early glaucomatous changes. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1586-90. doi: 10.1167/iovs.02-0666.
PubMed 12657596Liu JH, Sit AJ, Weinreb RN. Variation of 24-hour intraocular pressure in healthy individuals: right eye versus left eye. Ophthalmology. 2005 Oct;112(10):1670-5. doi: 10.1016/j.ophtha.2005.05.007.
PubMed 16095707Liu JH, Kripke DF, Twa MD, Hoffman RE, Mansberger SL, Rex KM, Girkin CA, Weinreb RN. Twenty-four-hour pattern of intraocular pressure in the aging population. Invest Ophthalmol Vis Sci. 1999 Nov;40(12):2912-7.
PubMed 10549652Bengtsson B, Leske MC, Hyman L, Heijl A; Early Manifest Glaucoma Trial Group. Fluctuation of intraocular pressure and glaucoma progression in the early manifest glaucoma trial. Ophthalmology. 2007 Feb;114(2):205-9. doi: 10.1016/j.ophtha.2006.07.060. Epub 2006 Nov 13.
PubMed 17097736Caprioli J, Coleman AL. Intraocular pressure fluctuation a risk factor for visual field progression at low intraocular pressures in the advanced glaucoma intervention study. Ophthalmology. 2008 Jul;115(7):1123-1129.e3. doi: 10.1016/j.ophtha.2007.10.031. Epub 2008 Feb 20.
PubMed 18082889Barkana Y, Anis S, Liebmann J, Tello C, Ritch R. Clinical utility of intraocular pressure monitoring outside of normal office hours in patients with glaucoma. Arch Ophthalmol. 2006 Jun;124(6):793-7. doi: 10.1001/archopht.124.6.793.
PubMed 16769832Hughes E, Spry P, Diamond J. 24-hour monitoring of intraocular pressure in glaucoma management: a retrospective review. J Glaucoma. 2003 Jun;12(3):232-6. doi: 10.1097/00061198-200306000-00009.
PubMed 12782841Schwartz GF, Quigley HA. Adherence and persistence with glaucoma therapy. Surv Ophthalmol. 2008 Nov;53 Suppl1:S57-68. doi: 10.1016/j.survophthal.2008.08.002.
PubMed 19038625Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E; Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003 Jan;121(1):48-56. doi: 10.1001/archopht.121.1.48.
PubMed 12523884Garway-Heath DF, Crabb DP, Bunce C, Lascaratos G, Amalfitano F, Anand N, Azuara-Blanco A, Bourne RR, Broadway DC, Cunliffe IA, Diamond JP, Fraser SG, Ho TA, Martin KR, McNaught AI, Negi A, Patel K, Russell RA, Shah A, Spry PG, Suzuki K, White ET, Wormald RP, Xing W, Zeyen TG. Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. Lancet. 2015 Apr 4;385(9975):1295-304. doi: 10.1016/S0140-6736(14)62111-5. Epub 2014 Dec 19.
PubMed 25533656Meier-Gibbons F, Berlin MS, Toteberg-Harms M. Twenty-four hour intraocular pressure measurements and home tonometry. Curr Opin Ophthalmol. 2018 Mar;29(2):111-115. doi: 10.1097/ICU.0000000000000460.
PubMed 29278546Xu SC, Gauthier AC, Liu J. The Application of a Contact Lens Sensor in Detecting 24-Hour Intraocular Pressure-Related Patterns. J Ophthalmol. 2016;2016:4727423. doi: 10.1155/2016/4727423. Epub 2016 Jul 25.
PubMed 27525110