Refractory Glaucoma
Conditions
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.
Interventions
DEVICEXEN 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
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Mean decrease in IOP | Baseline to Month 12 |
Countries
China
Outcome results
None listed