Clincosm LogoSign in Get a demo

Monitoring of the IOP After SLT Using iCare Home

Sponsor
St. Erik Eye Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03310788
Collaborator
(none)
60
Enrollment
1
Location
62.6
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Monitoring of the Intraocular Pressure After Selective Laser Trabeculoplasty Using iCare Home
    Actual Study Start Date :
    Oct 3, 2017
    Anticipated Primary Completion Date :
    Mar 20, 2022
    Anticipated Study Completion Date :
    Dec 20, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Lowering of IOP fluctuations after SLT [2 months]

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

    Secondary Outcome Measures

    1. Lowering of IOP level after SLT [2 months]

      Mean IOP pre- and post SLT

    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 SLT

    • reduced hand and arm mobility (e.g. 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

    • Principal Investigator: Enping Chen, MD Ph D, St. Erik Eye Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Enping Chen, MD Ph D, St. Erik Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT03310788
    Other Study ID Numbers:
    • HOME SLT
    First Posted:
    Oct 16, 2017
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Enping Chen, MD Ph D, St. Erik Eye Hospital
    IOP fluctuations
    iCare Home
    SLT
    self-tonometry
    Additional relevant MeSH terms:
    Exfoliation Syndrome
    Glaucoma, Open-Angle

    Study Results

    No Results Posted as of May 12, 2021