Hydrus(R) Microstent New Enrollment Post-Approval Study

  • End date
    Sep 25, 2024
  • participants needed
  • sponsor
    Ivantis, Inc.
Updated on 25 January 2021
brimonidine tartrate ophthalmic solution


To evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. This trial is a prospective, non-randomized, multicenter, single arm, post approval study. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.

Condition Glaucoma, Glaucoma, Pigmentary glaucoma, Open Angle Glaucoma, Primary Open Angle Glaucoma, Open Angle Glaucoma
Treatment Hydrus Microstent
Clinical Study IdentifierNCT04553523
SponsorIvantis, Inc.
Last Modified on25 January 2021


Yes No Not Sure

Inclusion Criteria

An operable age-related cataract with BCVA of 20/40 or worse
Diagnosis of POAG treated with no more than 4 topical hypotensive medications
Optic nerve appearance characteristic of glaucoma
Medicated IOP </= 31mmHg

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
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