Actively Recruiting

Age: 40Years - 90Years
All Genders
NCT06691555

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

Led by Davinci LTD · Updated on 2024-11-15

66

Participants Needed

1

Research Sites

3 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Davinci Eye Center, LTD

Tbilisi, Georgia, 0160

Actively Recruiting

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Research Team

N

Nikoloz Labauri, MD. FVRS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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