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

Not Applicable

Recruiting

• Conditions: Intraocular Pressure
• Interventions: Device: icare HOME device (Icare Oy, Vanda, Finland)

• Registration Number: NCT04485897
• Lead Sponsor: Luzerner Kantonsspital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-24
• Study Start: 2020-11-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
icare HOME	icare HOME device (Icare Oy, Vanda, Finland)	-

Primary Outcome Measures

Name	Time	Method
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.	4 years	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.

Secondary Outcome Measures

Name	Time	Method
variance of diurnal intraocular pressure	4 years	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
Influence of daily activities	4 years	Influence of daily activities (sports, alcohol and water intake) on intraocular measurements at home (questionnaire)
Change of treatment	4 years	Change of treatment due to intraocular pressure peaks during hospitalisation and/or measurements at home

Trial Locations

Locations (1)

Cantonal Hospital of Lucerne; 🇨🇭 Lucerne, Switzerland