Evaluation of Hydrus Microstent after cataract surgery for glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This post-approval study aims to assess the rate of malposition and clinical outcomes associated with the Hydrus Microstent within 24 months following its implantation. Participants will undergo uncomplicated cataract surgery with a monofocal intraocular lens, followed by the placement of the Hydrus Microstent. The study includes a series of scheduled postoperative visits to monitor the subjects' progress and any complications. The research is sponsored by Alcon Research, following their acquisition of Ivantis, Inc.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sacramento Eye Consultants
  Sacramento, California, United States Recruiting
• Eye Center of Northern Colorado
  Loveland, Colorado, United States Recruiting
• Jones Eye Center PC
  Sioux City, Iowa, United States Recruiting
• Fraser Eye Care Center
  Fraser, Michigan, United States Recruiting
• Twin Cities Eye Consultants
  Coon Rapids, Minnesota, United States Recruiting
• Midwest Vision Research Foundation
  Chesterfield, Missouri, United States Recruiting

Study contacts

• Study coordinator: Alcon Call Center
• Email: alcon.medinfo@alcon.com
• Phone: 1-888-451-3937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.