Trials / Completed
CompletedNCT02006693
Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 199 (actual)
- Sponsor
- AqueSys, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study was to evaluate the AqueSys XEN Implant \[XEN® Gel Stent (XEN45 Implant)\] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | XEN® Gel Stent | The XEN® Gel Stent (XEN45 implant) was placed in the study eye. |
| PROCEDURE | Cataract Surgery | Participants diagnosed with a cataract elected to have cataract surgery. |
Timeline
- Start date
- 2013-12-05
- Primary completion
- 2016-02-09
- Completion
- 2017-01-26
- First posted
- 2013-12-10
- Last updated
- 2019-04-22
- Results posted
- 2019-04-22
Locations
21 sites across 9 countries: Austria, Belgium, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, Venezuela
Source: ClinicalTrials.gov record NCT02006693. Inclusion in this directory is not an endorsement.