Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma

Refractory Glaucoma Clinical Trial

Official title:

A Real-World Evidence Study to Evaluate the Safety and Effectiveness of XEN Glaucoma Treatment System (XEN) in Chinese Patients With Refractory Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303897
• Other study ID #: 1924-801-007
• Status: Completed
• Start date: December 19, 2019
• Est. completion date: March 3, 2022

Study information

• Verified date: April 2024
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 3, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Refractory Glaucoma

Intervention

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

Locations

Country	Name	City	State
China	Boao Super Hospital /ID# 233669	Qionghai	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean decrease in IOP		Baseline to Month 12

External Links

•   clinical study report synopsis