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

Glaucoma Clinical Trial

Official title:

Impact of Home Intraocular Pressure Telemonitoring on Intraocular Pressure Control and Glaucoma Progression - A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05940623
• Other study ID #: Protocol_iCare_v2_20230523
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 24, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: The University of Hong Kong
• Contact: Christopher Leung
• Phone: 39102673
• Email: cleung21[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Intraocular Pressure
• Primary Open Angle Glaucoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Icare Finland Oy

References & Publications (25)

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Bengtsson 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. — View Citation

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Caprioli 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. — View Citation

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. — View Citation

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Heijl A, Leske MC, Bengtsson B, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Measuring visual field progression in the Early Manifest Glaucoma Trial. Acta Ophthalmol Scand. 2003 Jun;81(3):286-93. doi: 10.1034/j.1600-0420.2003.00070.x. — View Citation

Hughes 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. — View Citation

Leske 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. — View Citation

Lin C, Mak H, Yu M, Leung CK. Trend-Based Progression Analysis for Examination of the Topography of Rates of Retinal Nerve Fiber Layer Thinning in Glaucoma. JAMA Ophthalmol. 2017 Mar 1;135(3):189-195. doi: 10.1001/jamaophthalmol.2016.5111. — View Citation

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Liu 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. — View Citation

Liu 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. — View Citation

Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549. — View Citation

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Mudie LI, LaBarre S, Varadaraj V, Karakus S, Onnela J, Munoz B, Friedman DS. The Icare HOME (TA022) Study: Performance of an Intraocular Pressure Measuring Device for Self-Tonometry by Glaucoma Patients. Ophthalmology. 2016 Aug;123(8):1675-1684. doi: 10.1016/j.ophtha.2016.04.044. Epub 2016 Jun 9. — View Citation

Nakakura S, Asaoka R, Terao E, Nagata Y, Fukuma Y, Oogi S, Shiraishi M, Kiuchi Y. Evaluation of rebound tonometer iCare IC200 as compared with IcarePRO and Goldmann applanation tonometer in patients with glaucoma. Eye Vis (Lond). 2021 Jul 1;8(1):25. doi: 10.1186/s40662-021-00249-z. — View Citation

Quigley 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. — View Citation

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Weinreb 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. — View Citation

Xu 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. — View Citation

Yu M, Lin C, Weinreb RN, Lai G, Chiu V, Leung CK. Risk of Visual Field Progression in Glaucoma Patients with Progressive Retinal Nerve Fiber Layer Thinning: A 5-Year Prospective Study. Ophthalmology. 2016 Jun;123(6):1201-10. doi: 10.1016/j.ophtha.2016.02.017. Epub 2016 Mar 19. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	RNFL and GCIPL thickness could be assessed by Optical coherence tomography (OCT), which analyze the temporal delay of backscattered light from tissue structures.; RNFL thickness (µm) could be measured by an optic disc cube OCT scan. RNFL thickness is presented on 2 circular charts, 1 with 12 equal sized sectors, and the other with 4 equal sectors each representing 1 quadrant (superior, nasal, temporal and inferior).; GCIPL thickness (µm) could be measured by a macular OCT scan. GCIPL thickness is presented on a thickness map, with 6 equal sized sectors.	From baseline to 30 months, at 3-month intervals

External Links

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