Evaluating the long-term safety and effectiveness of a modified silicone tube for glaucoma treatment
Official title: 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
Run by Davinci LTD · NCT06691555 · Data updated 2026-11-12
This study is testing a new silicone tube to see if it safely helps people with glaucoma manage their eye pressure and maintain good vision over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years to 90 Years |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Davinci LTD Academic / other |
| Locations | 1 site (Tbilisi) |
| Status | Recruiting |
| Started | November 8, 2024 |
| Main results expected | November 30, 2024 |
| Study ends | November 30, 2024 |
| Registry record updated | November 15, 2024 |
| Trial ID | NCT06691555 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals who have previously undergone treatment with a suprachoroidal silicone tube shunt and are willing to participate in follow-up assessments.
✕Probably not a fit
Patients who have conditions that may hinder their ability to attend follow-up visits or those who have not been treated with the SST shunt will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the long-term safety and efficacy of a modified suprachoroidal silicone tube (SST) shunt in patients with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PXG). Participants will undergo intraocular pressure (IOP) measurements, endothelial cell count evaluations, and assessments of best corrected visual acuity (BCVA) while being monitored for any adverse events related to the shunt. This study builds on previous research by focusing on the long-term impacts of the SST shunt on ocular health, particularly corneal endothelial health, over an extended follow-up period.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term management of glaucoma, potentially improving patient outcomes and quality of life.
How similar studies have gone: While this approach is relatively novel, previous studies on similar minimally invasive glaucoma surgeries have shown promising results, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Davinci Eye Center, LTD
Tbilisi, Georgia Recruiting
Study contacts
- Study coordinator: Nikoloz Labauri, MD. FVRS
- Email: nlabauri@yahoo.com
- Phone: +995599003744
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.