RecruitingNot Applicable

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

Georgia66 participantsStarted 2024-11-08

Plain-language 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

Who can participate

Age range

40 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Endothelial Cell Loss

Timeframe: From enrollment to the end of long term observational FU (average duration is 31 months with 8 months std. dev)

IOP Control: Success was defined as ≥20% reduction in IOP, with "complete success" for IOP control without medications, "qualified success" with medications, and "failure" for <20% IOP reduction or IOP >21 mmHg.

Timeframe: From enrollment to the end of long term observational FU (average duration is 31 months with 8 months std. dev)

Trial details

NCT IDNCT06691555

SponsorDavinci LTD

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-11-30

Contact for this trial

Nikoloz Labauri, MD. FVRS

+995599003744 nlabauri@yahoo.com

View on ClinicalTrials.gov More Glaucoma trials

Plain-language summary

Who can participate

Age range

40 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Endothelial Cell Loss

Timeframe: From enrollment to the end of long term observational FU (average duration is 31 months with 8 months std. dev)