A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma.
Inclusion Criteria:
Inclusion Criteria: - Diagnosis of ACG defined as areas of iridotrabecular contact present in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye - Study eye has healthy, free, and mobile conjunctiva in the target quadrant Exclusion Criteria: - Uncontrolled systemic disease (eg, diabetes, hypertension) - Known history of bleeding disorder or prolonged bleeding after surgery or those on pharmacologic blood thinners other than aspirin (up to 100 mg/day) - History of dermatologic keloid formation - Open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile glaucoma, secondary glaucoma in the study eye - History of following surgeries in the study eye: o incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions o corneal graft including partial grafts such as Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial keratoplasty o previous laser or incisional intraocular surgery that might interfere with the outcome of this trial - Previous glaucoma shunt implantation in the target quadrant in the study eye - Active or history of chronic uveitis in the study eye - Unable to discontinue contact lens wear in the study eye during the study
Vermont South, Victoria 3133, Australia
Taipei City, Taipei 11217, Taiwan
Manchester, Lancashire M13 9WL, United Kingdom