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

Recruiting now

Conditions studied: Glaucoma, Open Angle Glaucoma (OAG), POAG, Ocular Hypertension, Exfoliation Syndrome, Choroidal Effusions

In brief

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

Key facts

Study ID

NCT06691555

Run by

Davinci LTD

People needed

66

Starts

2024-11-08

Expected to finish

2024-11-30

Last updated by the study team

2024-11-15

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Davinci Eye Center, LTD — Tbilisi, Georgia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.