NCT05127551

Brief Summary

A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

November 27, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

2.3 years

First QC Date

November 9, 2021

Last Update Submit

August 13, 2024

Conditions

GlaucomaGlaucoma, Open-Angle

Keywords

GlaucomaMIGS

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Diurnal Intraocular Pressure

    Change in Mean Diurnal Intraocular Pressure from Baseline over time

    Month 24

Study Arms (2)

iStent Infinite

ACTIVE COMPARATOR

Subjects implanted with iStent Infinite system

Device: iStent Infinite

Competitor Device

ACTIVE COMPARATOR

Subject implanted with competitor device

Device: Competitor Device

Interventions

iStent InfiniteDEVICE

Implantation of the iStent Infinite

iStent Infinite
Competitor DeviceDEVICE

Implantation of competitor device

Competitor Device

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Primary Open-Angle Glaucoma (POAG) or Secondary Pseudoexfoliative Glacoma (PEXG) or Secondary Pigmentary Glaucoma (PG)

You may not qualify if:

  • Any other type of glaucoma including, but not limited to: traumatic glaucoma, angle recession glaucoma, uveitic glaucoma, neovascular glaucoma, angle closure glaucoma (ACG) and glaucoma associated with vascular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaukos Investigator Sites

Montreal, Qubec, H1A 0A1, Canada

Location

Related Publications (1)

  • Ahmed IIK, Berdahl JP, Yadgarov A, Reiss GR, Sarkisian SR Jr, Gagne S, Robles M, Voskanyan LA, Sadruddin O, Parizadeh D, Giamporcaro JE, Kothe AC, Katz LJ, Navratil T. Six-Month Outcomes from a Prospective, Randomized Study of iStent infinite Versus Hydrus in Open-Angle Glaucoma: The INTEGRITY Study. Ophthalmol Ther. 2025 May;14(5):1005-1024. doi: 10.1007/s40123-025-01126-x. Epub 2025 Mar 25.

    PMID: 40128494DERIVED

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 19, 2021

Study Start

November 27, 2021

Primary Completion

February 29, 2024

Study Completion

February 28, 2025

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations

CA(1)