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
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
Condition that could impact the ability of the participant to attend a follow-up visit as per the discretion of the investigator
The study is going to re-evaluate approximately 66 eyes, who had previously undergone SST shunt implantation, either as a standalone procedure or in combination with cataract surgery. These evaluations are going to be conducted within the period between 8 Nov/2024 and 30 Nov/2024.Participants in this observational study met the original inclusion criteria set forth in the retrospective trial. This included a cohort of Caucasian patients aged 41 to 88 years (mean age: 69), with a gender distribution of 40 men and 26 women. All patients were untreated with glaucoma surgeries or laser therapies prior to the SST implantation, providing a clean baseline for evaluating the SST device's isolated effects.
Other
Cross-sectional
Suprachoroidal silicone tube (SST) shunt
DeviceThis 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.
Endothelial Cell Loss
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.
Hypotony, defined as intraocular pressure (IOP) < 5 mmHg, categorized as either transient or permanent.
Device migration or extrusion, monitored to assess mechanical stability of the implant.
Adverse Events/Severe Adverse Events: Device-related or non-device-related
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