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Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05654493
Collaborator
(none)
50
Enrollment
1
Location
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the clinical outcomes of the Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) after 1 day, 1 week,1 month, 3 months, 6 months and one year of follow-up, with the intent to evaluate the efficacy of using MP-TSCPC to treat glaucoma patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients: Clinical Outcomes. Prospective Observational Cohort Study
    Actual Study Start Date :
    Apr 4, 2022
    Anticipated Primary Completion Date :
    Apr 4, 2023
    Anticipated Study Completion Date :
    Apr 4, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Change In IOP [Baseline, 12 months post procedure]

      Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg)

    Secondary Outcome Measures

    1. Number of anti-glaucoma medications [12 months]

      Number of anti-glaucoma medication drops

    2. Change in visual acuity [Baseline, 12 months post procedure]

      Change in visual acuity score

    3. Change in cup-disc ratio [Baseline, 12 months post procedure]

      Ratio of the size of the optic cup to the optic disc

    4. Change in visual field [Baseline, 12 months post procedure]

      Total area visible in peripheral vision when focused on a central point, reported in degrees

    5. Change in iris color [Baseline, 12 months post procedure]

      Number of subjects to have a change in their iris color

    6. Complications [12 months]

      Number of subjects to experience complications from the procedure

    Eligibility Criteria

    Criteria

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

    • Diagnose of glaucoma

    • Indication to be submitted to the procedure

    Exclusion Criteria:

    • Significant thinning of the sclera

    • Current eye infection or inflammation

    • Intraocular surgery performed less than 2 months prior to the enrollment in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Florida Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Syril Dorairaj, MBBS, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Syril K. Dorairaj, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05654493
    Other Study ID Numbers:
    • 19-008815
    First Posted:
    Dec 16, 2022
    Last Update Posted:
    Dec 16, 2022
    Last Verified:
    Dec 1, 2022
    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
    Additional relevant MeSH terms:
    Glaucoma

    Study Results

    No Results Posted as of Dec 16, 2022