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Hydrus® Microstent New Enrollment Post-Approval Study

The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 8 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks how often the Hydrus Microstent sits in the wrong place and causes health problems within 24 months after surgery. It is for people with an age-related cataract and primary open-angle glaucoma, a disease that harms the eye nerve. Participants have cataract surgery with an artificial lens that focuses at one distance, followed by placement of the microstent.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have an age-related cataract (a cloudy eye lens) that can be treated with surgery, with vision of 20/40 or worse even with glasses or contacts.
  • Have primary open-angle glaucoma treated with no more than 4 medicines put in the eye to lower eye pressure.
  • Have changes in the eye nerve that are typical of glaucoma.
  • Have eye pressure of 31 mmHg or less while taking medicine. mmHg is a unit used to measure pressure.
  • Other study rules may apply.

Who can't join

  • Have closed-angle glaucoma, where the eye's drainage angle is blocked.
  • Have glaucoma present at birth or caused by problems with eye development.
  • Have secondary glaucoma, which is caused by another condition.
  • Use more than 4 medicines to lower eye pressure.
  • Have had argon laser treatment to improve eye drainage, a trabeculectomy (drainage surgery), a drainage tube, or other surgery to drain eye fluid or reduce its production.
  • Have had an eye device implanted or surgery involving the eye's drainage tissue or drainage canal.
  • Other study rules may apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (22)

CA

CO

IA

KS

MD

MI

MN

MO

NC

NV

OH

PA

TX

UT

WI