Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma
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.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|XEN Glaucoma Stent
Device: XEN Glaucoma Stent
Data are collected from patients who are implanted with XEN via the specific urgent medical needs for named patient use regulatory pathway in Hainan
Primary Outcome Measures
- 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
- Mean decrease in IOP [Baseline to Month 12]
- 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
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
Contacts and Locations
|1||Boao Super Hospital /ID# 233669||Qionghai||Hainan||China||571434|
Sponsors and Collaborators
- Study Director: ALLERGAN INC., Allergan
Study Documents (Full-Text)None provided.
- Additional information on study locations near you may be found at AllerganClinicalTrials.com.
- To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.