iStent Inject New Enrollment Post-Approval Study | NCT04624698

Studies
iStent Inject New Enrollment Post-Approval Study

NCT04624698

Sponsor

Glaukos Corporation

Status

Unknown status

Last Update Posted

Feb 23, 2024Actual

Enrollment

358Estimated

Phase

Not Applicable

Conditions

Glaucoma, Open-Angle
Glaucoma

Interventions

iStent Inject Implantation

Countries

United States

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

Feb 2024

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

Sep 22, 2020Actual

Primary Completion Date

May 2026Estimated

Completion Date

May 2026Estimated

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

Feb 22, 2024

Last Update Posted Date

Feb 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.

Detailed Description

To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

358Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Implantation	Experimental	Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device.	Device: iStent Inject Implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iStent Inject Implantation	Device	Subjects will be implanted with the iStent Injection Micro-Bypass device	Implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
iStent inject placement and stability	The rate of clinically relevant complications associated with iStent inject placement and stability	36 Months

Secondary Outcomes

Measure	Description	Time Frame
Sight-threatening adverse events	Rate of occurrence of sight-threatening adverse events	36 Months

Other Outcomes

Measure	Description	Time Frame
Other adverse events	Rate of other adverse events	36 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female ≥ 22 years of age
Mild to moderate primary open-angle glaucoma
Scheduled to undergo cataract surgery
Able and willing to attend scheduled follow-up exams for three years postoperatively
Able and willing to provide written informed consent on the IRB approved Informed Consent Form

Operative Inclusion Criterion:
Successful, uncomplicated cataract surgery

Exclusion Criteria:

Angle closure glaucoma
Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Doctors of Arizona, PLLC		Phoenix	Arizona	85003	United States
Wolstan and Goldberg Eye Associates

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

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

ID	Term
D005902	Glaucoma, Open-Angle
D005901	Glaucoma