Evaluating the long-term safety and effectiveness of a modified silicone tube for glaucoma treatment
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
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 |
|---|---|
| Enrollment | 66 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Davinci LTD Academic / other |
| Locations | 1 site (Tbilisi) |
| Trial ID | NCT06691555 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is relatively novel, previous studies on similar minimally invasive glaucoma surgeries have shown promising results, indicating potential for success.
Eligibility criteria
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 this trial is running
Tbilisi
- Davinci Eye Center, LTD — Tbilisi, Georgia (Recruiting)
Study contacts
- Study coordinator: Nikoloz Labauri, MD. FVRS
- Email: nlabauri@yahoo.com
- Phone: +995599003744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.