Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evolution of IOP after XEN® Gel Stent implantation

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

Group Type OTHER

XEN® Gel Stent implantation

Intervention Type PROCEDURE

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.

Interventions

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XEN® Gel Stent implantation

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.

Intervention Type PROCEDURE

Other Intervention Names

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XEN® Gel Stent, Aquesys

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No