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Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Primary Purpose

Glaucoma, Glaucoma, Open-Angle, Glaucoma, Angle-Closure

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
XEN® Gel Stent implantation
Sponsored by
Swiss Vision Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Mild to moderate glaucoma patients
  • Have given written informed consent
  • Aged 18 years or older of either sex

Exclusion Criteria:

  • Patients not able to understand the character of the study
  • Participation in other clinical research within the last 4 weeks
  • Patients with end-stage glaucoma
  • Patients with glaucoma surgery done before

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Evolution of IOP after XEN® Gel Stent implantation

    Arm Description

    To study the efficacy of the XEN® Gel Stent in lowering the IOP.

    Outcomes

    Primary Outcome Measures

    Intraocular pressure
    Change in IOP before and after XEN® Gel Stent implantation

    Secondary Outcome Measures

    Number of needlings
    Number of needlings performed during the follow-up after surgery
    Number of antiglaucomatous medications
    Change in number of antiglaucomatous medications before and after the surgery.

    Full Information

    First Posted
    April 28, 2017
    Last Updated
    May 4, 2022
    Sponsor
    Swiss Vision Network
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03151577
    Brief Title
    Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent
    Official Title
    Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    January 31, 2019 (Actual)
    Study Completion Date
    May 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Swiss Vision Network

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.
    Detailed Description
    To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery. Follow-up period is 2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Glaucoma, Primary Open Angle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Intraocular pressure, adverse events, complications, number of medications in mild to moderate glaucoma patients who underwent XEN® Gel Stent implantation were recorded. Data were collected in a 2 years follow-up.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Evolution of IOP after XEN® Gel Stent implantation
    Arm Type
    Other
    Arm Description
    To study the efficacy of the XEN® Gel Stent in lowering the IOP.
    Intervention Type
    Procedure
    Intervention Name(s)
    XEN® Gel Stent implantation
    Other Intervention Name(s)
    XEN® Gel Stent, Aquesys
    Intervention Description
    Minimally invasive glaucoma surgery (MIGS) which consists of implanting a XEN® Gel Stent in the irido-corneal angle of the eye to drain the aqueous humour in the sub-conjunctival space to lower the IOP.
    Primary Outcome Measure Information:
    Title
    Intraocular pressure
    Description
    Change in IOP before and after XEN® Gel Stent implantation
    Time Frame
    Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2
    Secondary Outcome Measure Information:
    Title
    Number of needlings
    Description
    Number of needlings performed during the follow-up after surgery
    Time Frame
    2 years
    Title
    Number of antiglaucomatous medications
    Description
    Change in number of antiglaucomatous medications before and after the surgery.
    Time Frame
    Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mild to moderate glaucoma patients Have given written informed consent Aged 18 years or older of either sex Exclusion Criteria: Patients not able to understand the character of the study Participation in other clinical research within the last 4 weeks Patients with end-stage glaucoma Patients with glaucoma surgery done before

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32341321
    Citation
    Gillmann K, Bravetti GE, Rao HL, Mermoud A, Mansouri K. Bilateral XEN Stent Implantation: A Long-term Prospective Study of the Difference in Outcomes Between First-operated and Fellow Eyes. J Glaucoma. 2020 Jul;29(7):536-541. doi: 10.1097/IJG.0000000000001520.
    Results Reference
    derived
    PubMed Identifier
    30095603
    Citation
    Mansouri K, Gillmann K, Rao HL, Guidotti J, Mermoud A. Prospective Evaluation of XEN Gel Implant in Eyes With Pseudoexfoliative Glaucoma. J Glaucoma. 2018 Oct;27(10):869-873. doi: 10.1097/IJG.0000000000001045.
    Results Reference
    derived

    Learn more about this trial

    Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

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