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

Plain Language Summary

Simplified for easier understanding

This study is following up on patients who previously received a modified suprachoroidal silicone tube (SST) shunt — a small device implanted in the eye to drain fluid and lower pressure — as a treatment for glaucoma. The goal is to assess the long-term safety and effectiveness of this device years after the original implantation. **You may be eligible if...** - You previously received a suprachoroidal silicone tube shunt as part of glaucoma treatment - You are willing and able to attend a follow-up visit - You are capable of giving informed consent **You may NOT be eligible if...** - You have a condition that prevents you from attending the follow-up visit, at the investigator's discretion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.