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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04485897
Other study ID # 895689
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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