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