Glaucoma Clinical Trial
Official title:
Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent
Verified date | May 2022 |
Source | Swiss Vision Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Swiss Vision Network |
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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