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

RecruitingOBSERVATIONAL
Enrollment

66

Participants

Timeline

Start Date

November 8, 2024

Primary Completion Date

November 30, 2024

Study Completion Date

November 30, 2024

Conditions
GlaucomaOpen Angle Glaucoma (OAG)POAGOcular HypertensionExfoliation SyndromeChoroidal Effusions
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.

Trial Locations (1)

0160

RECRUITING

Davinci Eye Center, LTD, Tbilisi

All Listed Sponsors
lead

Davinci LTD

OTHER