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NCT03445806 Clinical Trial

IOP Monitoring After Trabeculectomy Using iCare Home

Glaucoma, Open-Angle Clinical Trial

Official title:
IOP Monitoring After Trabeculectomy Using iCare Home

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03445806
Other study ID # Home Trab
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 26, 2018
Est. completion date March 22, 2021

Study information
Verified date May 2021
Source St. Erik Eye Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate how much trabeculectomy influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).

Description:

Fifty glaucoma patients (POAG and PEX) planned for trabeculectomy will be recruited. At baseline, patients will be trained to use the iCare Home tonometer (RTHome), a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. At the same visit, a new measurement will be obtained by the study staff, an optometrist or a nurse, using the same device. No IOP values will be visible for the examiner at that point. A single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will come for a second visit where new measurements will be made in the same way as at baseline. In between visits, patients will borrow the iCare Home tonometer to measure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve. Two-three months after trabeculectomy, a new IOP curve will be obtained following the same procedure as pre-operatively. There will be no restrictions in patients' daily activities regarding diet, physical activity or slee. If patients use any eyedrops, they will continue to use them as prescribed.

Recruitment information / eligibility
Status Terminated
Enrollment 50
Est. completion date March 22, 2021
Est. primary completion date March 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - POAG - PXG Exclusion Criteria: - previous trabeculectomy - reduced hand and arm mobility (e. due to rheumatism)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden St Erik Eye Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
St. Erik Eye Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lowering of IOP levels after trabeculectomy Mean (SD) IOP pre- and post trabeculectomy 2-3 months
Secondary Lowering of IOP fluctuations after trabeculectomy Mean (SD) IOP range pre- and post trabeculectomy 2-3 months
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