RecruitingNot Applicable

Hydrus® Microstent New Enrollment Post-Approval Study

United States545 participantsStarted 2020-08-25

Plain-language summary

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.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of occurrence of clinically significant device malposition associated with clinical sequelae

Timeframe: Day 0 operative, up to Month 24 postoperative

Trial details

NCT IDNCT04553523

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Alcon Call Center

1-888-451-3937 alcon.medinfo@alcon.com

View on ClinicalTrials.gov More Primary Open Angle Glaucoma trials