search
Back to results

Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma

Primary Purpose

Pseudoexfoliation Glaucoma, Primary Open-angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Micropulse laser trabeculoplasty
Sponsored by
University Hospital of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudoexfoliation Glaucoma focused on measuring Pseudoexfoliation Glaucoma, Primary Open-angle Glaucoma, Micropulse Laser Trabeculoplasty, Intraocular Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with POAG or PEXG under treatment with glaucoma agents requiring additional reduction of IOP, age older than 18 years, patients willing to provide informed consent to participate in the study and to adhere to the follow-up schedule.

Exclusion Criteria:

  • pre-existing corneal pathology or scar, history of any previous ocular surgery or any planned ocular surgery during the study, history of prior laser trabeculoplasty, end-stage glaucoma with advanced visual field defect, monocular patients, history of trauma, and concurrent systemic or topical steroid use
  • patients unable to present for follow up

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PEXG treated with MLT

    Arm Description

    Patients with pseudoexfoliation glaucoma (PEXG) under prostaglandine analogue monotherapy with inadequate IOP control treated with 360-degrees 532nm micropulse laser trabeculoplasty (MLT)

    Outcomes

    Primary Outcome Measures

    Intraocular Pressure
    The change in IOP at 12 months versus baseline and the percentage of patients with ≥20% reduction in IOP.

    Secondary Outcome Measures

    Intraocular Pressure
    Change in IOP and the percentage of ≥20% IOP reduction at 1, 3 and 6 months after MLT

    Full Information

    First Posted
    March 23, 2018
    Last Updated
    April 2, 2018
    Sponsor
    University Hospital of Patras
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03483402
    Brief Title
    Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma
    Official Title
    Study of the Efficacy of a Single Session Micropulse Laser Trabeculoplasty as an Adjunctive Measure in Decreasing Intraocular Pressure in Patients Suffering From Pseudoexfoliation Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    March 30, 2018 (Actual)
    Study Completion Date
    April 2, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital of Patras

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the effect of a single session of micropulse laser trabeculoplasty (MLT) on cornea in eyes with primary open glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG).
    Detailed Description
    Patients with PEXG under prostaglandine analogue monotherapy with inadequate IOP control are treated with 360-degrees 532nm MLT. Patients are evaluated at 1 day, 1 month, 3 months, 6 months and 12 months post-MLT. After trabeculoplasty patients are maintained in treatment with the same drug regimen as pre-MLT.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pseudoexfoliation Glaucoma, Primary Open-angle Glaucoma
    Keywords
    Pseudoexfoliation Glaucoma, Primary Open-angle Glaucoma, Micropulse Laser Trabeculoplasty, Intraocular Pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single-center, one-arm, prospective clinical trial.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PEXG treated with MLT
    Arm Type
    Experimental
    Arm Description
    Patients with pseudoexfoliation glaucoma (PEXG) under prostaglandine analogue monotherapy with inadequate IOP control treated with 360-degrees 532nm micropulse laser trabeculoplasty (MLT)
    Intervention Type
    Procedure
    Intervention Name(s)
    Micropulse laser trabeculoplasty
    Other Intervention Name(s)
    MLT Iridex IQ 532 laser system
    Intervention Description
    Micropulse laser trabeculoplasty is performed using the Iridex IQ 532 laser system (Iridex Corporation, 1212 Terra Bella Avenue, Mountain View, CA, USA) and 532 nm (green) wavelength MLT is applied with confluent applications to pigmented trabecular meshwork over 360 degrees using a 300 µm spot size, 300 ms duration, 1000 mW power and 15% duty cycle.
    Primary Outcome Measure Information:
    Title
    Intraocular Pressure
    Description
    The change in IOP at 12 months versus baseline and the percentage of patients with ≥20% reduction in IOP.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Intraocular Pressure
    Description
    Change in IOP and the percentage of ≥20% IOP reduction at 1, 3 and 6 months after MLT
    Time Frame
    1, 3 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with POAG or PEXG under treatment with glaucoma agents requiring additional reduction of IOP, age older than 18 years, patients willing to provide informed consent to participate in the study and to adhere to the follow-up schedule. Exclusion Criteria: pre-existing corneal pathology or scar, history of any previous ocular surgery or any planned ocular surgery during the study, history of prior laser trabeculoplasty, end-stage glaucoma with advanced visual field defect, monocular patients, history of trauma, and concurrent systemic or topical steroid use patients unable to present for follow up
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Constantine D Georgakopoulos, MD, PhD
    Organizational Affiliation
    University of Patras, Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30488265
    Citation
    Makri OE, Pallikari A, Pagoulatos D, Kagkelaris K, Kostopoulou EV, Georgakopoulos CD. Micropulse laser trabeculoplasty on pseuodexfoliation glaucoma patients under topical prostaglandin analogue monotherapy: 1-year results. Graefes Arch Clin Exp Ophthalmol. 2019 Feb;257(2):349-355. doi: 10.1007/s00417-018-4195-2. Epub 2018 Nov 28.
    Results Reference
    derived

    Learn more about this trial

    Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma

    We'll reach out to this number within 24 hrs