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

Glaukos

Status: Active, not recruiting

Conditions: Glaucoma; Glaucoma, Open-Angle

Treatments: Device: iStent Infinite; Device: Competitor Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05127551

INFI-103-COMP

Details and patient eligibility

About

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

Enrollment: 179 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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179 participants in 2 patient groups

iStent Infinite

Active Comparator group

Description:

Subjects implanted with iStent Infinite system

Treatment:

Device: iStent Infinite

Competitor Device

Active Comparator group

Description:

Subject implanted with competitor device

Treatment:

Device: Competitor Device