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

NCT04485897 | Recruiting

• 1 other identifier: 895689
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Glaucoma; self-monitoring; intraocular pressure; icare HOME; rebound tonometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• variance of diurnal intraocular pressure

  4 years

• Influence of daily activities

  4 years

• Change of treatment

  4 years

Study Arms (1)

icare HOME

EXPERIMENTAL

Device: icare HOME device (Icare Oy, Vanda, Finland)

Interventions

icare HOME device (Icare Oy, Vanda, Finland) DEVICE

icare HOME device versus hospital based measurements

icare HOME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Cantonal Hospital of Lucerne

Lucerne, 6004, Switzerland

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Raphael Fritsche, MD

CONTACT

0041 205 33 76; raphael.fritsche@luks.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 24, 2020
• Study Start: November 26, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)