Long-Term Safety and Effectiveness of the Modified Suprachoroidal Silicone Tube Shunt in Adults with Primary Open-Angle and Pseudoexfoliative Glaucoma

What this Trial Is About

This research aims to evaluate the long-term safety and effectiveness of a modified suprachoroidal silicone tube SST shunt in patients with primary open-angle glaucoma POAG and pseudoexfoliative glaucoma PXG. The study follows up on a previous trial that initially assessed the SST shunts impact on intraocular pressure IOP reduction and early safety, now focusing on its effects over an extended period, including its influence on corneal endothelial cell health. The SST shunt is a device implanted to help lower eye pressure by draining fluid from the front chamber of the eye to the space behind the eye suprachoroidal space. This observational study involves patients who have already received the SST shunt, either alone or with cataract surgery. No new treatments are given during this study, allowing researchers to observe the natural effects of the device over time. Participants will undergo regular measurements of eye pressure, endothelial cell counts, visual acuity tests, and assessments of the optic nerve cup-to-disc ratio. Researchers will monitor any complications related to the shunt, such as device movement or adverse events. The study includes follow-up visits over an average of 31 months to understand how well the SST shunt maintains pressure control and preserves corneal health in the long term.

Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt