Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03151577

Enrollment

150

Registered

2017-05-12

Start date

2015-01-01

Completion date

2023-05-31

Last updated

2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREXEN® 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026