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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
45–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
