Pilot Study on a New Self Adjustable Glaucoma Drainage Device

Prior treatment

• Previous filtering surgery, secondary glaucoma, severe systemic disease, pregnancy, breastfeeding, or inability to understand or provide informed consent.
  • Pregnant or breastfeeding women, or women of childbearing potential who are not willing to use a medically acceptable method of contraception from the screening visit until the 12-month follow-up visit.
  • Known or suspected allergy or hypersensitivity to any component of the device (e.g., silicone).
  • Current participation, or participation within the last 30 days (from the screening visit), in another investigational drug or interventional device clinical trial.

• Men and women aged 18 to 90 years.
  • Diagnosis of primary open-angle glaucoma meeting the following criteria:
• Intraocular pressure (IOP) not controlled by at least one (1) or more classes of topical IOP-lowering medications, and
• Eye without visual acuity.
  • Patients must be able to understand the study requirements and provide written informed consent.
  • Patients must be willing to follow study instructions, agree to comply with all study procedures, and be able to attend all scheduled follow-up visits for at least 6 months after surgery.