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

Launched by DAVINCI LTD · Nov 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for glaucoma, specifically looking at a device called a suprachoroidal silicone tube (SST) shunt. Glaucoma is a condition that affects the eyes and can lead to vision loss if not treated. The trial aims to find out if this new device is safe and effective for adults aged 40 to 90 who have primary open-angle glaucoma or pseudo-exfoliative glaucoma.

To be eligible for this study, participants need to be between 40 and 90 years old and have been diagnosed with one of the types of glaucoma mentioned. They also need to be able to understand and sign a consent form to join the study. If you decide to participate, you can expect to have the SST device implanted in your eye and then come back for regular follow-up visits to monitor your progress. It's important to know that if you have certain other eye conditions or have had specific glaucoma treatments in the past, you may not be able to join this trial.

Gender

ALL

Eligibility criteria

• 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.