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NCT03151577 Clinical Trial

Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Glaucoma Clinical Trial

Official title:
Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03151577
Other study ID # 2016-02077
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2015
Est. completion date May 31, 2023

Study information
Verified date May 2022
Source Swiss Vision Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date May 31, 2023
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Swiss Vision Network

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure 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 Number of needlings Number of needlings performed during the follow-up after surgery 2 years
Secondary Number of antiglaucomatous medications 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
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