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

Glaucoma, Open-Angle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154330
• Other study ID #: SCS_001
• Status: Recruiting
• Start date: November 20, 2023
• Est. completion date: December 23, 2023

Study information

• Verified date: November 2023
• Source: Davinci LTD
• Contact: Nikoloz Labauri, MD. FVRS
• Phone: 599003744
• Email: nlabauri[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt for the treatment of primary open angle and exfoliative glaucomas.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 91
• Est. completion date: December 23, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Choroidal Effusions
• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Open-Angle
• Pseudo Exfoliation Syndrome

Locations

Country	Name	City	State
Georgia	Davinci Eye Center, LTD	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Davinci LTD

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main outcome measures	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.	1 month