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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intraocular Pressure

Intervention / Treatment
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* Device: icare HOME device (Icare Oy, Vanda, Finland)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: icare HOME<br> | Device: icare HOME device (Icare Oy, Vanda, Finland)<br>* icare HOME device versus hospital based measurements<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, self-monitoring, intraocular pressure, icare HOME, rebound tonometry