Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Main outcome measures [1 month]
A successful outcome was defined as Intraocular Pressure (IOP) reduction in ≥20%, with the IOP range 5-21mm/Hg. Successful outcomes were further categorized into two groups: Complete success - IOP reduction in ≥20%, with unmedicated the IOP range 5-21mm/Hg and Qualified success where reduction and ranges of IOP is the same but with antiglaucoma medications. Failure was defined as IOP reduction in <20% or IOP >21mm/Hg at last follow up. Permanent hypotony was defined as IOP < 5mm/Hg during more than 4 weeks.
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Davinci Eye Center, LTD | Tbilisi | Georgia | 0160 |
Sponsors and Collaborators
- Davinci LTD
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCS_001