iStent Inject Trabecular Micro-Bypass System Continuation... | NCT04624685

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2020Actual

Primary Completion Date

Jan 20, 2021Actual

Completion Date

Dec 2021Estimated

First Submitted Date

Nov 5, 2020

First Submission Date that Met QC Criteria

Nov 5, 2020

First Posted Date

Nov 12, 2020Actual

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

Oct 18, 2021

Last Update Posted Date

Oct 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Long term follow up of subjects in the IDE study for iStent Inject to monitor safety

Detailed Description

To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).

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

475Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
iStent inject Placement and Stability	Rate of clinically relevant complications associated with iStent inject placement and stability.	60 Months

Secondary Outcomes

Measure	Description	Time Frame
Sight-Threatening Adverse Events	Rate of occurrence of sight-threatening adverse events	60 Months

Other Outcomes

Measure	Description	Time Frame
Secondary Surgical Interventions	Rate of Secondary Surgical Interventions	60 Months
Adverse Events	Rate of other adverse Events	60 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Randomized subject followed for 24 months in the GC-008 study
Able to understand study requirements
Willing to attend scheduled follow-up exams for 5 years post-operatively
Able and willing to provide written informed consent on the IRB approved Informed Consent Form

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Up to 475 eyes of 475 subjects. This is based on the number of randomized subjects in the GC-008 study followed for 24 months.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Advanced Eye Research Institute		Glendale	Arizona	85306	United States
Vold Vision, PLLC

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases