Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas

NCT06154330 | Unknown

• 1 other identifier: SCS_001
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

To assess safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt for the treatment of primary open angle and exfoliative glaucomas.

Conditions

Glaucoma, Open-Angle; Suprachoroidal Space; Pseudo Exfoliation Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Main outcome measures

  A successful outcome was defined as Intraocular Pressure (IOP) reduction in ≥20%, with the IOP range 5-21mm/Hg. Successful outcomes were further categorized into two groups: Complete success - IOP reduction in ≥20%, with unmedicated the IOP range 5-21mm/Hg and Qualified success where reduction and ranges of IOP is the same but with antiglaucoma medications. Failure was defined as IOP reduction in \<20% or IOP \>21mm/Hg at last follow up. Permanent hypotony was defined as IOP \< 5mm/Hg during more than 4 weeks.

  1 month

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

All study patients were Caucasian

You may qualify if:

• Male or female subjects from 40 years up to 90 years old
• Diagnosis of primary open angle glaucoma (POAG) and pseudo-exfoliative glaucoma
• Subject is able to understand and sign a written informed consent form
• Subject who underwent SST implantation and agreed to come for the cross-sectional follow-up

You may not qualify if:

• Close angle forms of glaucoma
• Congenital or developmental glaucoma
• Pseudophakic with an anterior chamber intraocular lens (IOL), iris fixed IOL, or implantable contact lens (ICL)
• Prior glaucoma procedures such as Selective Laser Trabeculoplasty (SLT), Microinvasive Glaucoma Surgery (MIGS) or Episcleral Shunts
• History of corneal transplant, corneal refractive surgery, corneal dystrophy, or corneal ectasia (such as either keratoconus or keratoglobus) in the study eye
• Chronic ocular inflammatory disease, or clinically significant ocular inflammation or infection (e.g., uveitis, iritis, iridocyclitis, retinitis).
• Any condition that, in the Investigator´s opinion, can interfere with full participation in the study, including study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data.

Sponsors & Collaborators

• Davinci LTD: lead

Study Sites (1)

Davinci Eye Center, LTD

Tbilisi, 0160, Georgia

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Choroidal Effusions; Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Eye Abnormalities; Choroid Diseases; Uveal Diseases; Iris Diseases

Central Study Contacts

Nikoloz Labauri, MD. FVRS

CONTACT

599003744; nlabauri@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder and Managing Director, Principal Investigator

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: November 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 23, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

GE (1)