Glaucoma Clinical Trial
Official title:
iCare® Home vs Goldmann Applanation Tonometry: Agreement of the Methods and Comparison of Inter-observer Variation at a Tertiary Eye Centre
Verified date | May 2021 |
Source | St. Erik Eye Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Self-tonometry with iCare Home is regularly performed at Sankt Erik's Eye Hospital since a few years back. The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method, Goldman applanation tonometry (GAT), by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.
Status | Completed |
Enrollment | 61 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - primary open angle glaucoma (POAG) - pseudo-exfoliation glaucoma (PEX) - ocular hypertension (OHT) - no eye disease, Exclusion Criteria: - inability to perform measurements due to limited hand or arm mobility (eg rheumatism, tremor) - measurements outside the iCare® Home manufacturer's recommendations. |
Country | Name | City | State |
---|---|---|---|
Sweden | St Erik Eye Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
St. Erik Eye Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between iCare® Home inter-user measurements | iCare® Home measurements made by participants (patients and volunteers) will be compared to iCare® Home measurements made by trainers' using the same device on the same occasion | 12 months | |
Primary | Correlation between GAT measurements made by different healthcare personnel | GAT measurements made by iCare® Home trainers will be compared to GAT measurements made by other available healthcare personnel using a different device on the same occasion | 12 months | |
Secondary | Agreement between iCare® Home tonometry and GAT | Agreement, repeatability and reliability of measurements made with iCare® Home tonometry and GAT will be assessed using Bland Altman analysis, ANOVA and interclass correlation coefficient (ICC). | 12 months |
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