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Clinical Trials/NCT03310788
NCT03310788
Unknown
Not Applicable

Monitoring of the Intraocular Pressure After Selective Laser Trabeculoplasty Using iCare Home

St. Erik Eye Hospital1 site in 1 country60 target enrollmentOctober 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma Open-Angle Primary
Sponsor
St. Erik Eye Hospital
Enrollment
60
Locations
1
Primary Endpoint
Lowering of IOP fluctuations after SLT
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 3, 2017
End Date
December 20, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Erik Eye Hospital
Responsible Party
Principal Investigator
Principal Investigator

Enping Chen

MD Ph D

St. Erik Eye Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

Lowering of IOP fluctuations after SLT

Time Frame: 2 months

The amplitude of the IOP fluctuations pre- and post SLT will be compared

Secondary Outcomes

  • Lowering of IOP level after SLT(2 months)

Study Sites (1)

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