Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Not Applicable

• Conditions: Glaucoma, Angle-Closure; Glaucoma; Glaucoma, Open-Angle; Glaucoma, Primary Open Angle
• Interventions: Procedure: XEN® Gel Stent implantation

• Registration Number: NCT03151577
• Lead Sponsor: Swiss Vision Network

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.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Primary Completion: 2019-01-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evolution of IOP after XEN® Gel Stent implantation	XEN® Gel Stent implantation	To study the efficacy of the XEN® Gel Stent in lowering the IOP.

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2	Change in IOP before and after XEN® Gel Stent implantation

Secondary Outcome Measures

Name	Time	Method
Number of needlings	2 years	Number of needlings performed during the follow-up after surgery
Number of antiglaucomatous medications	Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2	Change in number of antiglaucomatous medications before and after the surgery.