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

NCT ID: NCT04303897

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-19

Study Completion Date

2022-03-03

Brief Summary

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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

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Conditions

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Refractory Glaucoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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XEN Glaucoma Stent

XEN Glaucoma Stent

Intervention Type DEVICE

Data are collected from patients who are implanted with XEN via the specific urgent medical needs for named patient use regulatory pathway in Hainan

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

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Boao Super Hospital /ID# 233669

Qionghai, Hainan, China

Site Status

Countries

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China

Related Links

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Other Identifiers

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1924-801-007

Identifier Type: -

Identifier Source: org_study_id

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