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

Davinci LTD

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06154330

SCS_001

Details and patient eligibility

About

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

Enrollment: 91 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No 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.