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Taking people in GeorgiaNo phase

Long-term study of a glaucoma drainage tube in people with open-angle glaucoma

Follows people with open-angle glaucoma after a modified suprachoroidal silicone tube shunt.

Plain-language title generated from the registry record
Registry title: Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt

Key facts

Where
Tbilisi, GeorgiaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 90 years old?

Source: NCT06691555, who can take part

Where in Georgia

  • Davinci Eye Center, LTDTbilisi, GeorgiaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Davinci LTD
Trial code
NCT06691555
Record updated
15 November 2024
Original description
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).Read full original descriptionShow less

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

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

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

ClinicalTrials.gov NCT06691555