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

Recruitingn/aAges 40 Years - 90 YearsAllDavinci LTD
NCT06691555 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Condition that could impact the ability of the participant to attend a follow-up visit as per the discretion of the investigator
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What it tests

  • Suprachoroidal silicone tube (SST) shunt
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Where

1 site
Davinci Eye Center, LTD
Tbilisi, Georgia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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