Glaucoma, Open-Angle, Pseudo Exfoliation Syndrome, Suprachoroidal Space
Conditions
Keywords
MIGS, Suprachoroidal Space, Glaucoma, Open-Angle, Suprachoroidal Silicone Tube, Suprachoroidal Shunt, Glaucoma Shunt
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.
Interventions
None listed
Sponsors
Davinci LTD
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Georgia
Contacts
Primary ContactNikoloz Labauri, MD. FVRS
Outcome results
None listed