Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma
Completed
- Conditions
- Refractory Glaucoma
- Interventions
- Device: XEN Glaucoma Stent
- Registration Number
- NCT04303897
- Lead Sponsor
- Allergan
- Brief Summary
Real-world evidence study to assess the safety and effectiveness of XEN® Glaucoma Treatment System in Chinese patients with refractory glaucoma. Participants will be (prospective) or have already been (retrospective) implanted with XEN via specific urgent medical need.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
- Patients with refractory glaucomas, including cases where previous surgical treatment has failed, cases of POAG, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy
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Exclusion Criteria
- Angle closure glaucoma where angle has not been surgically opened
- Previous glaucoma shunt/valve in the target quadrant
- Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (eg, pterygium) in the target quadrant
- Active inflammation (eg, blepharitis, conjunctivitis, keratitis, uveitis)
- Active iris neovascularization or neovascularization of the iris within six months of the surgical date
- Anterior chamber intraocular lens
- Presence of intraocular silicone oil
- Vitreous present in the anterior chamber
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description XEN Glaucoma Stent XEN Glaucoma Stent -
- Primary Outcome Measures
Name Time Method Percentage of patients achieving at least a 20% reduction from intraocular pressure (IOP) while on the same number or fewer number of IOP lowering medications than at baseline Baseline to Month 12
- Secondary Outcome Measures
Name Time Method Mean decrease in IOP Baseline to Month 12
Trial Locations
- Locations (1)
Boao Super Hospital /ID# 233669
🇨🇳Qionghai, Hainan, China