Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

Study Overview
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Brief Summary
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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.

Official Title
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Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: XEN® Gel Stent
* Procedure: Cataract Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of primary open angle glaucoma Participants are taking at least one and no more than four topical IOP-lowering medications. Exclusion Criteria: Angle Closure Glaucoma Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: XEN® Gel Stent<br>The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. | Device: XEN® Gel Stent<br>* The XEN® Gel Stent (XEN45 implant) was placed in the study eye.<br>* Other names: XEN45 Implant;|
| Other: XEN® Gel Stent with Cataract Surgery<br>The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract. | Procedure: Cataract Surgery<br>* Participants diagnosed with a cataract elected to have cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12 | IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement. | Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative) | 
| Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12 | The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement. | Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative) | 
| Mean Change From Baseline in IOP in the Study Eyes to Month 24 | IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement. | Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative) | 
| Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24 | The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement. | Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XEN, Primary Open Angle Glaucoma, Filtration Device, Ab interno