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

Intraocular Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04485897
• Other study ID #: 895689
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2024
• Source: Luzerner Kantonsspital
• Contact: Raphael Fritsche, MD
• Phone: 0041 205 33 76
• Email: raphael.fritsche[@]luks.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Device:
• icare HOME device (Icare Oy, Vanda, Finland)
icare HOME device versus hospital based measurements

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital of Lucerne	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Influence of daily activities	Influence of daily activities (sports, alcohol and water intake) on intraocular measurements at home (questionnaire)	4 years
Secondary	Change of treatment	Change of treatment due to intraocular pressure peaks during hospitalisation and/or measurements at home	4 years