Status:
UNKNOWN
Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas
Lead Sponsor:
Davinci LTD
Conditions:
Glaucoma, Open-Angle
Suprachoroidal Space
Eligibility:
All Genders
40-90 years
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 23 2023
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT06154330
Start Date
November 20 2023
End Date
December 23 2023
Last Update
December 4 2023
Active Locations (1)
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1
Davinci Eye Center, LTD
Tbilisi, Georgia, 0160