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

Recruiting

• Conditions: Glaucoma, Open-Angle; Suprachoroidal Space; Pseudo Exfoliation Syndrome

• Registration Number: NCT06154330
• Lead Sponsor: Davinci LTD

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-20
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-11-23
• Last Update Submitted: 2023-11-23
• Study First Posted: 2023-12-04
• Last Update Posted: 2023-12-04
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main outcome measures	1 month	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.

Trial Locations

Locations (1)

Davinci Eye Center, LTD; 🇬🇪 Tbilisi, Georgia