Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Swiss Vision Network150 enrolled

Overview

To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

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

Interventions

XEN® Gel Stent implantationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Intraocular pressure

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 Outcomes

Number of needlings

Number of needlings performed during the follow-up after surgery

Time frame: 2 years

Number of antiglaucomatous medications

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

Data from ClinicalTrials.gov

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