Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Swiss Vision Network

Status: Unknown

Conditions: Glaucoma, Primary Open Angle; Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure

Treatments: Procedure: XEN® Gel Stent implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03151577

2016-02077

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Evolution of IOP after XEN® Gel Stent implantation

Other group

Description:

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

Treatment:

Procedure: XEN® Gel Stent implantation