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

Sponsor

Davinci LTD (Other)

Overall Status

Recruiting

CT.gov ID

NCT06154330

Collaborator

(none)

Enrollment

Location

1.1

Anticipated Duration (Months)

83.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle Suprachoroidal Space Pseudo Exfoliation Syndrome

Study Design

Study Type:

Observational

Anticipated Enrollment :

91 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 20, 2023

Anticipated Primary Completion Date :

Dec 20, 2023

Anticipated Study Completion Date :

Dec 23, 2023

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.