Hydrus(R) Microstent New Enrollment Post-Approval Study

  • STATUS
    Recruiting
  • End date
    Sep 25, 2024
  • participants needed
    330
  • sponsor
    Ivantis, Inc.
Updated on 25 January 2021
cataract
brimonidine tartrate ophthalmic solution
hypotensive

Summary

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.

Details
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

Eligibility

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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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