Status:
COMPLETED
Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma
Lead Sponsor:
Allergan
Conditions:
Refractory Glaucoma
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 3 2022
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04303897
Start Date
December 19 2019
End Date
March 3 2022
Last Update
April 12 2024
Active Locations (1)
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1
Boao Super Hospital /ID# 233669
Qionghai, Hainan, China, 571434