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

August 15, 2023 updated by: Professor Christopher K.S. Leung, The University of Hong Kong

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:

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Management Paradigm I: Standard care and home IOP telemonitoring with smart phone-based intervention
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
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
No Intervention: Management paradigm II: Standard care and smart phone-based 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinic-measured Goldmann applanation tonometry measurements collected at 3-month interval over 30 months of study follow-up.
Time Frame: From baseline to 30 months, at 3-month intervals
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: From baseline to 30 months, at 3-month intervals

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Icare Finland Oy

Investigators

  • Principal Investigator: Christopher Leung, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 24, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

July 4, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol_iCare_v2_20230523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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