Monitoring of the IOP After SLT Using iCare Home

• Conditions: Glaucoma Open-Angle Primary; Pseudo Exfoliation Syndrome

• Registration Number: NCT03310788
• Lead Sponsor: St. Erik Eye Hospital

Brief Summary

The purpose of this study is to investigate how much selective trabeculoplasty (SLT) 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

Sixty glaucoma patients (POAG and PEX) planned for SLT will be recruited.

At baseline, patients will be trained to use the iCare Home tonometer, 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. Thereafter, 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. Thereafter, a single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will then borrow the iCare Home tonometer to meaure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve. Patients will come for a second visit where new measurements will be made in the same way as at baseline.

Two months after SLT, a new IOP curve will be obtained following the same procedure as pre-operatively. Patients' daily activities (diet, motion or sleeping habits) will not be controlled.

Study Timeline

• Study First Submitted: 2017-10-02
• Study Start: 2017-10-03
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-16
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-12
• Primary Completion: 2022-03-20
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• POAG
• PXG

Exclusion Criteria

• previous SLT
• reduced hand and arm mobility (e.g. due to rheumatism)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lowering of IOP fluctuations after SLT	2 months	The amplitude of the IOP fluctuations pre- and post SLT will be compared

Secondary Outcome Measures

Name	Time	Method
Lowering of IOP level after SLT	2 months	Mean IOP pre- and post SLT

Trial Locations

Locations (1)

St Erik Eye Hospital; 🇸🇪 Stockholm, Sweden