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Hydrus® Microstent New Enrollment Post-Approval Study

Alcon Research · NCT04553523

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 45+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
545
US sites recruiting
13
Study start
August 25, 2020
Record last updated
September 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Hydrus Microstent; Cataract surgery; Monofocal IOL

Conditions: Primary Open Angle Glaucoma

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Alcon Call Center · 1-888-451-3937 · alcon.medinfo@alcon.com
Hydrus® Microstent New Enrollment Post-Approval Study (NCT04553523) | Bored Studies