Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab externo approach. Adverse events and intraocular pressure will be assessed. XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States. All participants will receive XEN45 implanted using the ab externo approach on Day 1 and will be followed for 12 months. Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Ab externo implant
Vold Vision /ID# 245285
Fayetteville, Arkansas, United States
UCLA Doheny Eye Center /ID# 227587
Pasadena, California, United States
Ventura Ophthalmology /ID# 227585
Ventura, California, United States
East Coast Institute for Research /ID# 255508
Jacksonville, Florida, United States
Center for Sight - Sarasota /ID# 227577
Sarasota, Florida, United States
Percentage of Participants Achieving Effectiveness of XEN45
Effectiveness is defined as achieving 20% or more reduction of intraocular pressure (IOP) from baseline and on the same or fewer number of glaucoma medications than at baseline without secondary surgical intervention for IOP (SSII).
Time frame: Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
New Vision Eye Center /ID# 261053
Vero Beach, Florida, United States
Georgia Eye Partners /ID# 245203
Atlanta, Georgia, United States
Stiles Eyecare Excellence /ID# 227576
Overland Park, Kansas, United States
The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355
Bethesda, Maryland, United States
Vance Thompson Vision /ID# 261125
Alexandria, Minnesota, United States
...and 15 more locations