IOP Monitoring After Trabeculectomy Using iCare Home

ID: NCT03445806
Status: Recruiting
Phase: N/A
Start Date: February 01, 2018
First Submitted: February 15, 2018
Last Updated: February 22, 2018
Results: N/A
Organization: St. Erik Eye Hospital
Sponsors & Collaborators: St. Erik Eye Hospital
Location: Sweden
Conditions: Glaucoma, Open-Angle, Pseudo Exfoliation Syndrome
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Study Description

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.
Condition or disease Intervention/treatment Phase

Glaucoma, Open-Angle

Pseudo Exfoliation Syndrome

N/A

Tracking Information

First Submitted DateFebruary 15, 2018
Last Update Posted DateFebruary 22, 2018
Anticipated Start DateFebruary 01, 2018
Anticipated Completion DateJune 01, 2019
Anticipated Primary Completion DateMarch 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Lowering of IOP levels after trabeculectomy [Time Frame: 2-3 months]

    Mean (SD) IOP pre- and post trabeculectomy

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Lowering of IOP fluctuations after trabeculectomy [Time Frame: 2-3 months]

    Mean (SD) IOP range pre- and post trabeculectomy

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleIOP Monitoring After Trabeculectomy Using iCare Home
Official TitleIOP Monitoring After Trabeculectomy Using iCare Home
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.

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
50
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Glaucoma, Open-Angle
Pseudo Exfoliation Syndrome
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodProbability 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 trabeculectomy.
Intervention
Not Available
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Recruiting
Enrollment50
Completion DateJune 01, 2019
Eligibility Criteria: Inclusion Criteria:
- POAG
- PXG

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

Administrative Information

NCT Number:NCT03445806
Other Study ID Numbers
Home Trab
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
Not Available