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

NCT ID: NCT04485897

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-26
• Study Completion Date: 2024-08-01

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.

Conditions

Intraocular Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

icare HOME

Group Type: EXPERIMENTAL

icare HOME device (Icare Oy, Vanda, Finland)

Intervention Type: DEVICE

icare HOME device versus hospital based measurements

Interventions

icare HOME device (Icare Oy, Vanda, Finland)

icare HOME device versus hospital based measurements

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Luzerner Kantonsspital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cantonal Hospital of Lucerne

Lucerne, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Raphael Fritsche, MD

Role: CONTACT

raphael.fritsche@luks.ch

0041 205 33 76

Other Identifiers

895689

Identifier Type: -

Identifier Source: org_study_id