iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study

NCT04624685 | Unknown DMC

• 1 other identifier: IG2M-104-CONT
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• iStent inject Placement and Stability

  Rate of clinically relevant complications associated with iStent inject placement and stability.

  60 Months

Secondary Outcomes (1)

• Sight-Threatening Adverse Events

  60 Months

Other Outcomes (2)

• Secondary Surgical Interventions

  60 Months

• Adverse Events

  60 Months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (24)

Arizona Advanced Eye Research Institute

Glendale, Arizona, 85306, United States

Location

Vold Vision, PLLC

Fayetteville, Arkansas, 72704, United States

Location

North Bath Eye Associates, Inc.

Santa Rosa, California, 95401, United States

Location

Eye Center of northern Colorado, PC

Fort Collins, Colorado, 80528, United States

Location

Argus Research

Cape Coral, Florida, 33904, United States

Location

International Research Center

Tampa, Florida, 33603, United States

Location

Center for Sight

Venice, Florida, 34285, United States

Location

Clayton Eye Clinical Research, LLC.

Morrow, Georgia, 30260, United States

Location

Chicago Eye Specialists

Chicago, Illinois, 60619, United States

Location

Arbor Center for Eye Care

Orland Park, Illinois, 60467, United States

Location

Stiles Eyecare Excellence

Overland Park, Kansas, 66213, United States

Location

D'Ambrosio Eye Care

Lancaster, Massachusetts, 01523, United States

Location

Kresge Eye Institute / Wayne State University

Detroit, Michigan, 48201, United States

Location

Discover Vision Centers

Independence, Missouri, 64055, United States

Location

Northern New Jersey Eye Institute

South Orange, New Jersey, 07079, United States

Location

Glaucoma Consultants of the Capital Region

Slingerlands, New York, 12159, United States

Location

Oklahoma eye Surgeons, PLLC

Oklahoma City, Oklahoma, 73112, United States

Location

Keystone Research

Austin, Texas, 78731, United States

Location

Ophthalmology Associates

Fort Worth, Texas, 76102, United States

Location

Parkhurst Nuvision

San Antonio, Texas, 78229, United States

Location

R and R Eye Resarch, LLC

San Antonio, Texas, 78229, United States

Location

Vistar Eye Center

Roanoke, Virginia, 24016, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

The Eye Center of Racine and Kenosha

Racine, Wisconsin, 53405, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: January 15, 2020
• Primary Completion: January 20, 2021
• Study Completion: December 1, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)