NCT04624698

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
358

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

5.6 years

First QC Date

November 5, 2020

Last Update Submit

February 22, 2024

Conditions

Glaucoma, Open-AngleGlaucoma

Outcome Measures

Primary Outcomes (1)

  • iStent inject placement and stability

    The rate of clinically relevant complications associated with iStent inject placement and stability

    36 Months

Secondary Outcomes (1)

  • Sight-threatening adverse events

    36 Months

Other Outcomes (1)

  • Other adverse events

    36 Months

Study Arms (1)

Implantation

EXPERIMENTAL

Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device.

Device: iStent Inject Implantation

Interventions

iStent Inject ImplantationDEVICE

Subjects will be implanted with the iStent Injection Micro-Bypass device

Implantation

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Successful, uncomplicated cataract surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Eye Doctors of Arizona, PLLC

Phoenix, Arizona, 85003, United States

Location

Wolstan and Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Glaucoma Associates of Texas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 12, 2020

Study Start

September 22, 2020

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)