RecruitingNCT06691555

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

The Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt in Patients with Primary Open-angle Glaucoma (POAG) and Pseudo-exfoliative Glaucoma (PXG) Over an Extended Follow-up Period

Sponsor

Davinci LTD

Enrollment

66 participants

Start Date

Nov 8, 2024

Study Type

OBSERVATIONAL

Conditions

Glaucoma Ocular Hypertension Open-angle Glaucoma (OAG)POAG Exfoliation Syndrome Choroidal Effusions

Summary

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

Eligibility

Min Age: 40 YearsMax Age: 90 Years

Inclusion Criteria3

Previously were treated with Suprachoroidal silicone tube shunt
Willing and able to participate in this cross sectional observational follow up
Participant capable of giving informed consent

Exclusion Criteria1

Condition that could impact the ability of the participant to attend a follow-up visit as per the discretion of the investigator

Interventions

DEVICESuprachoroidal 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.