Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma
Completed
- Conditions
- Refractory Glaucoma
- 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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie XEN stent efficacy in refractory glaucoma patients?
How does the XEN Glaucoma Treatment System compare to trabeculectomy in managing refractory glaucoma in China?
Are there specific biomarkers that predict successful intraocular pressure reduction with XEN stent implantation?
What are the most common adverse events associated with XEN stent use in refractory glaucoma and how are they managed?
What alternative minimally invasive glaucoma surgery (MIGS) devices are being evaluated alongside XEN for refractory glaucoma treatment in Asia?
Trial Locations
- Locations (1)
Boao Super Hospital /ID# 233669
🇨🇳Qionghai, Hainan, China
Boao Super Hospital /ID# 233669🇨🇳Qionghai, Hainan, China