Monitoring of the IOP After SLT Using iCare Home

ID: NCT03310788
Status: Recruiting
Phase: N/A
Start Date: October 03, 2017
First Submitted: October 02, 2017
Last Updated: October 10, 2017
Results: N/A
Organization: St. Erik Eye Hospital
Sponsors & Collaborators: St. Erik Eye Hospital
Location: Sweden
Conditions: Glaucoma Open-Angle Primary, Pseudo Exfoliation Syndrome
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Study Description

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.
Condition or disease Intervention/treatment Phase

Glaucoma Open-Angle Primary

Pseudo Exfoliation Syndrome

N/A

Tracking Information

First Submitted DateOctober 02, 2017
Last Update Posted DateOctober 10, 2017
Actual Start DateOctober 03, 2017
Anticipated Completion DateDecember 20, 2019
Actual Primary Completion DateDecember 20, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Lowering of IOP fluctuations after SLT [Time Frame: 2 months]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Lowering of IOP level after SLT [Time Frame: 2 months]

    Mean IOP pre- and post SLT

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleMonitoring of the IOP After SLT Using iCare Home
Official TitleMonitoring of the Intraocular Pressure After Selective Laser Trabeculoplasty Using iCare Home
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 TypeObservational
Study PhaseN/A
Estimated Enrollment
60
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Glaucoma Open-Angle Primary
Pseudo Exfoliation Syndrome
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationConsecutive male and female patients, older than 18 y.o., at St Erik's Eye Hospital in Stockholm, Sweden, diagnosed with POAG or PXG and listed for a SLT.
Intervention
Not Available
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Recruiting
Enrollment60
Completion DateDecember 20, 2019
Eligibility Criteria: Inclusion Criteria:
- POAG
- PXG

Exclusion Criteria:
- previous SLT
- reduced hand and arm mobility (e.g. due to rheumatism)
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Sweden

Administrative Information

NCT Number:NCT03310788
Other Study ID Numbers
HOME SLT
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyEnping Chen, St. Erik Eye Hospital
Study Sponsor
St. Erik Eye Hospital
Collaborators
Not Available
Investigators
Principal Investigator
Enping Chen, MD Ph D
St. Erik Eye Hospital