Self-monitoring of the Intraocular Pressure Versus Hospital-based Diurnal Monitoring

Can Self-monitoring of the Intraocular Pressure With the Icare HOME Make Hospital-based Diurnal Monitoring Redundant?

Glaucoma remains the leading cause of irreversible blindness worldwide. Glaucoma represents a group of diseases that lead to optic nerve damage and corresponding deterioration of the visual field.

Elevated intraocular pressure remains the most important risk factor. Interestingly, glaucomatous damage sometimes occurs despite seemingly normal intraocular pressure.

Recent studies suggest pressure peaks, which are missed under the current practice of spot intraocular measurements during office hours. In order to detect pressure peaks diurnal measurements are mandatory. Costly in-hospital diurnal measurements are the current standard.

The primary study objective is to verify that self-tonometry at home can provide valuable information when looking for pressure peaks in patients with glaucoma.

Study Overview

• Status: Recruiting
• Conditions: Intraocular Pressure
• Intervention / Treatment: Device: icare HOME device (Icare Oy, Vanda, Finland)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raphael Fritsche, MD; Phone Number: 0041 205 33 76; Email: raphael.fritsche@luks.ch

Study Locations

• Switzerland
  • Lucerne, Switzerland, 6004
    • Recruiting
    • Cantonal Hospital of Lucerne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Informed consent
• Subjects aged 18 and older
• Glaucoma patients and healthy controls
• Best corrected visual acuity >0.1
• Astigmatism ≤ 3dpt.
• Good compliance
• Central corneal thickness (400-650μm)
• Passed certification procedure (detailed description under: Measurements and procedures)
• Therapeutic regimen unchanged throughout the past 30 days

Exclusion Criteria:

• History of ocular trauma
• Corneal condition interfering with tonometry (keratoconus, corneal scaring) Visual acuity <0.1
• Physical or mental disability interfering with self-tonometry (e.g. arthritis, Parkinson's disease)
• Dry eye disease
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Pregnancy
• Breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: icare HOME	Device: icare HOME device (Icare Oy, Vanda, Finland); icare HOME device versus hospital based measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of an in- hospital diurnal pressure pattern of intraocular pressure to the pattern derived from self-tonometry using icare HOME in an outpatient setting.	Statistical methods for analysis of continuous method comparison data will be applied. The primary goal is to quantify the extent of agreement between two methods (Intraocular pressure measurement in-hospital and at home) and determine whether they sufficiently agree to be used interchangeably.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variance of diurnal intraocular pressure	Quantitative evaluation of day to day variance of diurnal intraocular pressure measurement in an out-hospital setting in patients with open angle glaucoma, normal tension glaucoma and healthy controls	4 years
Influence of daily activities	Influence of daily activities (sports, alcohol and water intake) on intraocular measurements at home (questionnaire)	4 years
Change of treatment	Change of treatment due to intraocular pressure peaks during hospitalisation and/or measurements at home	4 years

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Glaucoma; self-monitoring; intraocular pressure; icare HOME; rebound tonometry
• Other Study ID Numbers: 895689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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