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

NCT06691555 | Recruiting

• 1 other identifier: SCS_L_002
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma; Open Angle Glaucoma (OAG); POAG; Ocular Hypertension; Exfoliation Syndrome; Choroidal Effusions

Keywords

MIGS; Suprachoroidal Space; Glaucoma; Open-Angle Glaucoma; Suprachoroidal Silicone Tube; Suprachoroidal Shunt; Glaucoma Shunt

Outcome Measures

Primary Outcomes (2)

• Endothelial Cell Loss

  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.

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

Secondary Outcomes (3)

• Hypotony, defined as intraocular pressure (IOP) < 5 mmHg, categorized as either transient or permanent.

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

• Device migration or extrusion, monitored to assess mechanical stability of the implant.

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

• Adverse Events/Severe Adverse Events: Device-related or non-device-related

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

Study Arms (1)

Group 1 that includes Primary Open-Angle Glaucoma and Pseudoexfoliative Glaucoma Patients

This cohort includes patients diagnosed with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PXG) who have undergone suprachoroidal silicone tube (SST) shunt implantation. The study focuses on assessing the long-term safety and efficacy of the SST shunt, monitoring intraocular pressure (IOP) control, endothelial cell count (ECC) changes, and any adverse events over an extended follow-up period. This observational cohort includes patients aged 41-88 years, treated with the SST shunt either alone or in combination with cataract surgery, and meeting the inclusion criteria from a prior retrospective study.

Device: Suprachoroidal silicone tube (SST) shunt

Interventions

Suprachoroidal silicone tube (SST) shunt DEVICE

This intervention involves implanting a modified suprachoroidal silicone tube (SST) shunt, derived from the Aurolab Aqueous Drainage Device (AADI), to lower intraocular pressure in patients with primary open-angle and pseudoexfoliative glaucoma. The SST shunt, measuring 13.0-15.0 mm with a 0.3 mm inner and 0.6 mm outer diameter, is designed to reach the posterior suprachoroidal space. Six slits near the distal end aid aqueous outflow. Implantation involves creating a scleral flap, accessing the SCS, and placing the distal end in the SCS and proximal end in the anterior chamber (AC). The shunt is secured with sutures, and viscoelastic is injected into the AC to prevent hypotony. No antimetabolites or cautery are used.

Group 1 that includes Primary Open-Angle Glaucoma and Pseudoexfoliative Glaucoma Patients

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is going to re-evaluate approximately 66 eyes, who had previously undergone SST shunt implantation, either as a standalone procedure or in combination with cataract surgery. These evaluations are going to be conducted within the period between 8 Nov/2024 and 30 Nov/2024.Participants in this observational study met the original inclusion criteria set forth in the retrospective trial. This included a cohort of Caucasian patients aged 41 to 88 years (mean age: 69), with a gender distribution of 40 men and 26 women. All patients were untreated with glaucoma surgeries or laser therapies prior to the SST implantation, providing a clean baseline for evaluating the SST device's isolated effects.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Davinci LTD: lead

Study Sites (1)

Davinci Eye Center, LTD

Tbilisi, 0160, Georgia

RECRUITING

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Exfoliation Syndrome; Choroidal Effusions

Condition Hierarchy (Ancestors)

Eye Diseases; Iris Diseases; Uveal Diseases; Eye Abnormalities; Choroid Diseases

Central Study Contacts

Nikoloz Labauri, MD. FVRS

CONTACT

+995599003744; nlabauri@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 15, 2024
• Study Start: November 8, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)