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Recruiting NCT04553523

Hydrus® Microstent New Enrollment Post-Approval Study

Conditions: Primary Open Angle Glaucoma

Sex: All
Ages: 45 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 545
Sponsor: Alcon Research

Location: Coastal Vision Irvine California

Summary

The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.

Eligibility Criteria

Inclusion Criteria: * An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse; * Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications; * Optic nerve appearance characteristic of glaucoma; * Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Closed angle forms of glaucoma; * Congenital or developmental glaucoma; * Secondary glaucoma; * Use of more than 4 ocular hypotensive medications; * Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery; * Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal; * Other protocol-defined exclusion criteria may apply.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04553523). StuddyBuddy aggregates publicly available trial information.