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IOP Monitoring After Trabeculectomy Using iCare Home

IOP Monitoring After Trabeculectomy Using iCare Home

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03445806
Enrollment
50
Registered
2018-02-26
Start date
2018-02-26
Completion date
2021-03-22
Last updated
2021-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open-Angle, Pseudo Exfoliation Syndrome

Keywords

IOP fluctuations, iCare Home, Trabeculectomy, self-tonometry

Brief 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).

Detailed 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.

Interventions

None listed

Sponsors

St. Erik Eye Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* POAG * PXG

Exclusion criteria

* previous trabeculectomy * reduced hand and arm mobility (e. due to rheumatism)

Design outcomes

Primary

MeasureTime frameDescription
Lowering of IOP levels after trabeculectomy2-3 monthsMean (SD) IOP pre- and post trabeculectomy

Secondary

MeasureTime frameDescription
Lowering of IOP fluctuations after trabeculectomy2-3 monthsMean (SD) IOP range pre- and post trabeculectomy

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026