Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
- Conditions
- Angle-ClosureGlaucoma
- Interventions
- Device: XEN45
- Registration Number
- NCT03362931
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description XEN45 Glaucoma Treatment System (hereafter referred to as XEN) XEN45 XEN45 unilaterally implanted in the study eye
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12 Month 12 IOP will be measured using a Goldmann applanation tonometer
- Secondary Outcome Measures
Name Time Method Change From Baseline the Number of Concomitant IOP-lowering Medications Month 12 The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.
Trial Locations
- Locations (16)
Tan Tock Seng Hospital /ID# 233014
🇸🇬Singapore, Singapore
Buddhist Tzu Chi General Hospital /ID# 232664
🇨🇳Hualien, Taiwan
Nuh Medical Centre /ID# 232905
🇸🇬Singapore, Singapore
Queen Victoria Hospital /ID# 232812
🇬🇧East Grinstead, West Sussex, United Kingdom
Royal Surrey County Hospital /ID# 233028
🇬🇧Guildford, England, United Kingdom
Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765
🇦🇺Vermont South, Victoria, Australia
Marsden Eye Specialists Parramatta /ID# 232761
🇦🇺Paramatta, New South Wales, Australia
Melbourne Eye Specialists /ID# 232767
🇦🇺Fitzroy, Victoria, Australia
Institut de loeil des Laurentides /ID# 232780
🇨🇦Boisbriand, Quebec, Canada
Prism Eye Institute /ID# 232917
🇨🇦Mississauga, Canada
Ophthalmology Clinic Bellevue /ID# 232782
🇨🇦Montreal, Quebec, Canada
Seoul National University Hospital /ID# 233099
🇰🇷Seoul, Korea, Republic of
Taipei Veterans General Hospital /ID# 232948
🇨🇳Taipei City, Taipei, Taiwan
Manchester University NHS Foundation Trust /ID# 232808
🇬🇧Manchester, Lancashire, United Kingdom
East Suffolk and North Essex NHS Foundation Trust /ID# 232804
🇬🇧Colchester, United Kingdom
NHS Lothian /ID# 233052
🇬🇧Edinburgh, United Kingdom