Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

May 4, 2022 updated by: Dr. Kaweh Mansouri, Swiss Vision Network
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • XEN® Gel Stent, Aquesys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
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
Change in IOP before and after XEN® Gel Stent implantation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of needlings
Time Frame: 2 years
Number of needlings performed during the follow-up after surgery
2 years
Number of antiglaucomatous medications
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
Change in number of antiglaucomatous medications before and after the surgery.
Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Vision Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 31, 2019

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-02077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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