Evaluating a new silicone tube shunt for treating certain types of glaucoma
Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas
This study is testing a new silicone tube shunt to see if it helps people with certain types of glaucoma manage their eye pressure and improve their eye health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 91 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Davinci LTD Academic / other |
| Locations | 1 site (Tbilisi) |
| Trial ID | NCT06154330 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt designed for patients with primary open-angle glaucoma and pseudoexfoliation glaucoma. Participants aged 40 to 90 who have undergone SST implantation will be followed up to evaluate the outcomes of this intervention. The study aims to gather data on the performance of the SST in managing intraocular pressure and overall eye health in affected individuals.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 90 diagnosed with primary open-angle glaucoma or pseudoexfoliation glaucoma who have undergone SST implantation.
Not a fit: Patients with closed-angle glaucoma, congenital glaucoma, or those who have had prior glaucoma surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a new treatment option for patients suffering from specific types of glaucoma, potentially improving their vision and quality of life.
How similar studies have performed: While this approach is innovative, similar studies on suprachoroidal shunts have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tbilisi
- Davinci Eye Center, LTD — Tbilisi, Georgia (Recruiting)
Study contacts
- Study coordinator: Nikoloz Labauri, MD. FVRS
- Email: nlabauri@yahoo.com
- Phone: 599003744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.