Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt
Recruiting · NCT06691555 · Observational (researchers observe without assigning treatment) · Lead sponsor: Davinci LTD
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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 is running
1 location listed.
- Davinci Eye Center, LTD - Tbilisi, Georgia