ClinicalTrials.gg
Status unknownNCT03151577Updated May 5, 2022

Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

An interventional study of XEN® Gel Stent implantation in Glaucoma, Glaucoma, Open-Angle and Glaucoma, Angle-Closure, sponsored by Swiss Vision Network. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Swiss Vision Network · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Jan 2015, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Glaucoma
  • Glaucoma, Open-Angle
  • Glaucoma, Angle-Closure
  • Glaucoma, Primary Open Angle
03

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's enrollment of 150 is above the median of 61 across 964 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Swiss Vision Network is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Mild to moderate glaucoma patients
  • Have given written
  • Aged 18 years or older of either sex

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Other
    Evolution of IOP after XEN® Gel Stent implantation

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

    Procedure: XEN® Gel Stent implantation

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.

    Also known as: XEN® Gel Stent, Aquesys

06

What researchers measure

Primary outcomes

  1. 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

  1. Number of needlings

    Number of needlings performed during the follow-up after surgery

    Time frame: 2 years

  2. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Gillmann K, Bravetti GE, Rao HL, Mermoud A, Mansouri K. Bilateral XEN Stent Implantation: A Long-term Prospective Study of the Difference in Outcomes Between First-operated and Fellow Eyes. J Glaucoma. 2020 Jul;29(7):536-541. doi: 10.1097/IJG.0000000000001520. PubMed 32341321 ↗
  • Mansouri K, Gillmann K, Rao HL, Guidotti J, Mermoud A. Prospective Evaluation of XEN Gel Implant in Eyes With Pseudoexfoliative Glaucoma. J Glaucoma. 2018 Oct;27(10):869-873. doi: 10.1097/IJG.0000000000001045. PubMed 30095603 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03151577
Lead sponsor
Swiss Vision Network
Responsible party
Dr. Kaweh Mansouri (MD, MPH, Swiss Vision Network) — Principal investigator
First posted
May 12, 2017
Start date
Jan 1, 2015
Primary completion
Jan 31, 2019
Completion
May 31, 2023 (estimated)
Last update
May 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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