NCT06691555Recruiting
Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt
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
Source: ClinicalTrials.gov · Last updated 15 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 66 (estimated)
- First submitted
- 9 Nov 2024
- Start date
- 8 Nov 2024
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Davinci LTD
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT06691555
What you commit to
- Study type: Observational
- Planned participants: 66
- From 8 Nov 2024 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Condition that could impact the ability of the participant to attend a follow-up visit as per the discretion of the investigator
Who the study is looking for
- 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
Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Davinci Eye Center, LTD Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.