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IOP Monitoring After Trabeculectomy Using iCare Home

Sponsor
St. Erik Eye Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03445806
Collaborator
(none)
50
Enrollment
1
Location
36.8
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    IOP Monitoring After Trabeculectomy Using iCare Home
    Actual Study Start Date :
    Feb 26, 2018
    Actual Primary Completion Date :
    Mar 22, 2021
    Actual Study Completion Date :
    Mar 22, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Lowering of IOP levels after trabeculectomy [2-3 months]

      Mean (SD) IOP pre- and post trabeculectomy

    Secondary Outcome Measures

    1. Lowering of IOP fluctuations after trabeculectomy [2-3 months]

      Mean (SD) IOP range pre- and post trabeculectomy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • POAG

    • PXG

    Exclusion Criteria:

    • previous trabeculectomy

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Erik Eye Hospital Stockholm Sweden 11282

    Sponsors and Collaborators

    • St. Erik Eye Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Enping Chen, Principal Investigator, St. Erik Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT03445806
    Other Study ID Numbers:
    • Home Trab
    First Posted:
    Feb 26, 2018
    Last Update Posted:
    May 13, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Enping Chen, Principal Investigator, St. Erik Eye Hospital
    IOP fluctuations
    iCare Home
    Trabeculectomy
    self-tonometry
    Additional relevant MeSH terms:
    Glaucoma, Open-Angle
    Exfoliation Syndrome

    Study Results

    No Results Posted as of May 13, 2021