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NCT04303897 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
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Recruiting NCT04921098 - CPC in Adult Refractory Glaucoma N/A
Completed NCT01404364 - Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye N/A
Completed NCT00971061 - Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma Phase 3
Not yet recruiting NCT05230355 - Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma N/A
Recruiting NCT00893490 - Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma Phase 1

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