XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 285
Summary
- Conditions
- Glaucoma
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to evaluate the ability of XEN to reduce IOP and reduce the amount of topical IOP-lowering medications in subjects poorly controlled on topical therapy. Patients will be randomized 2:1, resulting in approximat...
This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to evaluate the ability of XEN to reduce IOP and reduce the amount of topical IOP-lowering medications in subjects poorly controlled on topical therapy. Patients will be randomized 2:1, resulting in approximately 190 eyes being implanted with XEN and approximately 95 eyes will be receiving trabeculectomy. Subjects will be screened for enrollment and eligible candidates will be approached to ascertain interest in study participation. Study duration will be approximately 12 months.
Tracking Information
- NCT #
- NCT03654885
- Collaborators
- Not Provided
- Investigators
- Study Director: Mini Balaram, MD Allergan
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