NCT06691555 Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt
| NCT ID | NCT06691555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Davinci LTD |
| Condition | Glaucoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2024-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 66 participants in total. It began in 2024-11-08 with a primary completion date of 2024-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06691555 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06691555 currently recruiting?
Yes, NCT06691555 is actively recruiting participants. Contact the research team at nlabauri@yahoo.com for enrollment information.
Where is the NCT06691555 trial being conducted?
This trial is being conducted at Tbilisi, Georgia.
Who is sponsoring the NCT06691555 clinical trial?
NCT06691555 is sponsored by Davinci LTD. The trial plans to enroll 66 participants.