STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Exp... | NCT02825264

Studies
STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

NCT02825264

Sponsor

iSTAR Medical

Status

Active, not recruiting

Last Update Posted

Aug 9, 2022Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Open Angle Glaucoma

Interventions

STARflo Implant

Countries

Belgium
France
Germany
Hungary
Spain

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jun 20, 2016

First Submission Date that Met QC Criteria

Jul 6, 2016

First Posted Date

Jul 7, 2016Estimated

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

Aug 8, 2022

Last Update Posted Date

Aug 9, 2022Actual

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

Description Module

Brief Summary

STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe.

Detailed Description

This Clinical Experience Program is being initiated to expand the surgical and clinical practice knowledge about the use of STARflo for reducing intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world population of patients.

This program is designed to be an international multicenter observational study.

Patient data may be collected retrospectively and/or prospectively for up to 5 years after surgery.

The aim of this program is to document the patient's benefit following implantation of the STARflo implant in a real-word patient population, to learn about surgical practices and to collect data to support future cost-effectiveness analysis.

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STARflo		Patients who have been implanted with STARflo implant	Device: STARflo Implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
STARflo Implant	Device	All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection	STARflo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of intraocular pressure (IOP)	IOP reduction compared after 12 months compared to baseline IOP	at 12 Months

Secondary Outcomes

Measure	Description	Time Frame
Occurence of Ocular Adverse Events	to record and document all complications and Adverse Events/Adverse Device Effects occurred during and after surgery	up to 60 Months after surgery
Reduction of intraocular pressure (IOP) over time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo implant from 2011
Patients who have signed a Data Release form

Exclusion criteria:

Patients who did not sign a Data Release form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zubair Hussain, PhD	Sponsor Representative	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U.		Liège		4000	Belgium
Hospital de la Croix-Rousse

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

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided