Back to resultsLongitudinal 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
About this trial
This is an interventional treatment trial for Glaucoma
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
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
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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