Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor

NCT ID: NCT05127551

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-27

Study Completion Date

2025-02-28

Brief Summary

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

Detailed Description

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Conditions

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Glaucoma Glaucoma, Open-Angle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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iStent Infinite

Subjects implanted with iStent Infinite system

Group Type ACTIVE_COMPARATOR

iStent Infinite

Intervention Type DEVICE

Implantation of the iStent Infinite

Competitor Device

Subject implanted with competitor device

Group Type ACTIVE_COMPARATOR

Competitor Device

Intervention Type DEVICE

Implantation of competitor device

Interventions

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iStent Infinite

Implantation of the iStent Infinite

Intervention Type DEVICE

Competitor Device

Implantation of competitor device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Glaukos Investigator Sites

Montreal, Qubec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 40128494 (View on PubMed)

Other Identifiers

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INFI-103-COMP

Identifier Type: -

Identifier Source: org_study_id

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