Hydrus® Microstent New Enrollment Post-Approval Study

Launched by ALCON RESEARCH · Sep 11, 2020

Keywords

ClinConnect Summary

The Hydrus® Microstent New Enrollment Post-Approval Study is looking at the safety and effectiveness of a device called the Hydrus Microstent for patients with primary open-angle glaucoma. The goal of this study is to see if the microstent, which helps to lower eye pressure, is positioned correctly and to understand any potential problems that may arise in the two years following its placement. Participants will first have cataract surgery, and then the microstent will be implanted to help manage their glaucoma.

To be eligible for the study, participants should be at least 18 years old, have cataracts that affect their vision, and be diagnosed with primary open-angle glaucoma that is currently being treated with no more than four eye drops. It's important to note that certain conditions, like closed-angle glaucoma or previous eye surgeries, may exclude someone from joining the study. Those who participate can expect to receive regular check-ups to monitor their eye health and the performance of the microstent over time. This trial is currently recruiting participants, and all genders are welcome to apply.

Gender

ALL

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.