Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma

This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open-Angle Glaucoma, Glaucoma, OAG, XEN45, Glaucoma Gel Stent, XEN45 Glaucoma Treatment System Read More

Inclusion Criteria:

• Glaucoma in the study eye.

  1. Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy

  2. Study eye that meet at least one of the following criteria:

     • Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt) (a minimum of approximately 15 subjects will be enrolled)
     • Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
     • Have neovascular glaucoma
     • Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for a person with uncomplicated primary open-angle glaucoma (OAG).

     Note: To allow for a subgroup of participants who only have OAG uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion a (and not b) will be enrolled.

     Exclusion Criteria:

• A lack of healthy conjunctiva showing free mobility (free of scarring or evidence of prior surgery) in the target area.
• Excessive intraoperative bleeding, such that visualization in the study eye is impaired.
• Any anatomy or finding in the study eye that limits the investigator's ability to visualize the anterior chamber, angle, or target area of the conjunctiva.
• Other surgical complication that in the opinion of the investigator could impede proper placement of the Gel Stent.