Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliat… (NCT06154330) | Clinical Trial Compass
UnknownNot Applicable
Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas
Georgia91 participantsStarted 2023-11-20
Plain-language summary
To assess safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt for the treatment of primary open angle and exfoliative glaucomas.
Who can participate
Age range40 Years – 90 Years
SexALL
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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.