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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-90
SponsorDavinci LTD

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

Condition that could impact the ability of the participant to attend a follow-up visit as per the discretion of the investigator

Trial design

Treatments tested in this trial

  • Suprachoroidal silicone tube (SST) shunt

Treatment groups

66 Participants
are divided into 1 treatment group

Sponsors and collaborators