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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Georgia
Davinci Eye Center, LTD
RECRUITING
Tbilisi
Contact Information
Primary
Nikoloz Labauri, MD. FVRS
nlabauri@yahoo.com
+995599003744
Time Frame
Start Date: 2024-11-08
Estimated Completion Date: 2024-11-30
Participants
Target number of participants: 66
Treatments
Group 1 that includes Primary Open-Angle Glaucoma and Pseudoexfoliative Glaucoma Patients
This cohort includes patients diagnosed with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PXG) who have undergone suprachoroidal silicone tube (SST) shunt implantation. The study focuses on assessing the long-term safety and efficacy of the SST shunt, monitoring intraocular pressure (IOP) control, endothelial cell count (ECC) changes, and any adverse events over an extended follow-up period. This observational cohort includes patients aged 41-88 years, treated with the SST shunt either alone or in combination with cataract surgery, and meeting the inclusion criteria from a prior retrospective study.
Sponsors
Leads: Davinci LTD

This content was sourced from clinicaltrials.gov