Safety and Efficacy of Suprachoroidal Tube Shunt in Patie... | NCT06154330

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

NCT06154330

Sponsor

Davinci LTD

Status

Unknown status

Last Update Posted

Dec 4, 2023Actual

Enrollment

91Estimated

Phase

Not provided

Conditions

Glaucoma, Open-Angle
Suprachoroidal Space
Pseudo Exfoliation Syndrome

Interventions

Not provided

Countries

Georgia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2023Actual

Primary Completion Date

Dec 20, 2023Estimated

Completion Date

Dec 23, 2023Estimated

First Submitted Date

Nov 23, 2023

First Submission Date that Met QC Criteria

Nov 23, 2023

First Posted Date

Dec 4, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2023

Last Update Posted Date

Dec 4, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

91Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

All study patients were Caucasian

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Nikoloz Labauri, MD. FVRS	Contact	599003744	+995	nlabauri@yahoo.com

Facility	Status	City	State	ZIP	Country	Contacts
Davinci Eye Center, LTD	Recruiting	Tbilisi		0160	Georgia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D000080324	Choroidal Effusions
D017889	Exfoliation Syndrome

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases
D005124	Eye Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided