NCT06057051NARecruiting

Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma

Glaukos Corporation

Start Date

9/1/2023

Completion Date

8/1/2027

Summary

Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment

Eligibility Criteria

Age Range: 35 years to No maximum

Inclusion Criteria: * Diagnosis of primary open-angle glaucoma * Phakic or pseudophakic * Age 35 years or older Exclusion Criteria: * Traumatic, uveitic, neovascular, angle-closure glaucoma or * glaucoma associated with vascular disorders * Active corneal inflammation or edema * Retinal disorders not associated with glaucoma

Interventions

DEVICE

iStent Infinite

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Conditions

Glaucoma

Locations

Glaukos Investigator Site

Cincinnati, Ohio 45242

United States

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Lay summaries for EU CTR Annex V, pre-screen filtration, recruitment-creative regulatory operations, feasibility reporting.

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