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

NCT ID: NCT06154330

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-20

Study Completion Date

2023-12-23

Brief Summary

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

Detailed Description

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Conditions

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Glaucoma, Open-Angle Suprachoroidal Space Pseudo Exfoliation Syndrome

Keywords

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MIGS Suprachoroidal Space Glaucoma, Open-Angle Suprachoroidal Silicone Tube Suprachoroidal Shunt Glaucoma Shunt

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Davinci LTD

OTHER

Sponsor Role lead

Responsible Party

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Nikoloz Labauri

Founder and Managing Director, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Davinci Eye Center, LTD

Tbilisi, , Georgia

Site Status RECRUITING

Countries

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Georgia

Central Contacts

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Nikoloz Labauri, MD. FVRS

Role: CONTACT

Phone: 599003744

Email: [email protected]

Facility Contacts

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Nikoloz Labauri, MD. FVRS

Role: primary

Other Identifiers

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SCS_001

Identifier Type: -

Identifier Source: org_study_id