Testing the Safety and Effectiveness of the Vizio Aqueous Microshunt Device for Treating Refractory Glaucoma

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the Vizio Aqueous Microshunt, a medical device developed to treat refractory glaucoma by lowering intraocular pressure IOP to a level that may prevent further optic nerve damage without needing additional medications. Glaucoma is a major cause of irreversible blindness, and current drainage devices often still require medication. The Vizio device represents a next-generation technology developed to improve upon earlier devices with better healing and implantation techniques. Participants will receive the Vizio Aqueous Microshunt, which drains aqueous humor from the eyes anterior chamber to the eye surface, potentially improving IOP control predictability and reducing ocular surface symptoms common in glaucoma patients. The study is a single-arm clinical trial where participants will be implanted with the device and monitored. The trial builds on previous device versions and includes refined patient selection and physician training to enhance safety and efficacy. Throughout the 12-month study period, participants will undergo evaluations including applanation tonometry to measure IOP reduction and adverse event monitoring to assess safety. Additional assessments include responder rate and overall safety evaluations. Participants will have follow-up visits to monitor device performance and ocular health. The total study duration extends to primary completion by January 2028 and final completion by March 2029.

The Vizio Clinical Study