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

Conditions studied

Glaucoma, Open Angle Glaucoma (OAG), POAG, Ocular Hypertension, Exfoliation Syndrome, Choroidal Effusions

About this study

The goal of this observational study is to evaluate the long-term safety and efficacy of a modified suprachoroidal silicone tube (SST) shunt in treating patients with primary open-angle glaucoma (POAG) and pseudo-exfoliative glaucoma (PXG). The main questions it aims to answer are: Does the SST shunt maintain intraocular pressure (IOP) reduction over an extended follow-up period? What is the effect of the SST shunt on endothelial cell count (ECC) and overall corneal health? Participants will: Undergo intraocular pressure (IOP) measurements Have their endothelial cell count (ECC) evaluated Complete assessments of best corrected visual acuity (BCVA) Be assessed for C/D ratio Be monitored for adverse events or shunt-related complications over time

Interventions

• Device: Suprachoroidal silicone tube (SST) shunt — This intervention involves implanting a modified suprachoroidal silicone tube (SST) shunt, derived from the Aurolab Aqueous Drainage Device (AADI), to lower intraocular pressure in patients with primary open-angle and pseudoexfoliative glaucoma. The SST shunt, measuring 13.0-15.0 mm with a 0.3 mm inner and 0.6 mm outer diameter, is designed to reach the posterior suprachoroidal space. Six slits near the distal end aid aqueous outflow. Implantation involves creating a scleral flap, accessing the SCS, and placing the distal end in the SCS and proximal end in the anterior chamber (AC). The shunt is secured with sutures, and viscoelastic is injected into the AC to prevent hypotony. No antimetabolites or cautery are used.

Primary outcomes

• Endothelial Cell Loss (From enrollment to the end of long term observational FU (average duration is 31 months with 8 months std. dev))
• IOP Control: Success was defined as ≥20% reduction in IOP, with "complete success" for IOP control without medications, "qualified success" with medications, and "failure" for <20% IOP reduction or IOP >21 mmHg. (From enrollment to the end of long term observational FU (average duration is 31 months with 8 months std. dev))

Eligibility information

Study locations

• Davinci Eye Center, LTD, Tbilisi, 0160 Georgia