NCT04553523 Hydrus® Microstent New Enrollment Post-Approval Study
| NCT ID | NCT04553523 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alcon Research |
| Condition | Primary Open Angle Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 545 participants |
| Start Date | 2020-08-25 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 545 participants in total. It began in 2020-08-25 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Clinical Project Lead, CDMA Surgical
STUDY DIRECTOR
Alcon Research
Frequently Asked Questions
Who can join the NCT04553523 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Primary Open Angle Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04553523 currently recruiting?
Yes, NCT04553523 is actively recruiting participants. Contact the research team at alcon.medinfo@alcon.com for enrollment information.
Where is the NCT04553523 trial being conducted?
This trial is being conducted at Irvine, United States, Sacramento, United States, Loveland, United States, Sioux City, United States and 11 additional locations.
Who is sponsoring the NCT04553523 clinical trial?
NCT04553523 is sponsored by Alcon Research. The principal investigator is Clinical Project Lead, CDMA Surgical at Alcon Research. The trial plans to enroll 545 participants.