Hydrus® Microstent New Enrollment Post-Approval Study
CONFIRM
The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
2 other identifiers
interventional
545
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2020
CompletedFirst Submitted
Initial submission to the registry
September 11, 2020
CompletedFirst Posted
Study publicly available on registry
September 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
June 3, 2025
June 1, 2025
7.8 years
September 11, 2020
June 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
The position of the implant will be assessed visually intraoperatively and at each postoperative follow-up visit. Examples of clinically significant device malposition associated with clinical sequelae as listed in the protocol include secondary surgical intervention to modify device position or to remove the device (explantation), corneal endothelial touch by device, iris touch by the device associated with intraocular inflammation, pigment dispersion or other sequelae, central endothelial cell loss ≥30 percent, compromised corneal function, best-corrected visual acuity (BCVA) loss of 2 lines (10 letters) or more on the ETDRS chart, device obstruction requiring secondary surgical intervention, persistent anterior chamber inflammation with peripheral anterior synechiae, persistent anterior chamber inflammation without peripheral anterior synechiae, and chronic pain.
Day 0 operative, up to Month 24 postoperative
Secondary Outcomes (3)
Rate of occurrence of intraoperative ocular adverse events
Day 0 operative
Rate of occurrence of sight threatening postoperative adverse events
Up to Month 24
Rate of occurrence of other postoperative ocular adverse events
Up to Month 24
Study Arms (1)
Hydrus Microstent
EXPERIMENTALHydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)
Interventions
Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL.
Cataract surgery performed using standard anesthesia and phacoemulsification techniques
Commercially available monofocal intraocular lens as determined by the investigator
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (22)
Coastal Vision
Irvine, California, 92618, United States
Sacramento Eye Consultants
Sacramento, California, 95815, United States
Eye Center of Northern Colorado
Loveland, Colorado, 80538, United States
Jones Eye Center PC
Sioux City, Iowa, 51104, United States
Stiles Eyecare Excellence Cataracts and Glaucoma
Overland Park, Kansas, 66213, United States
Visionary Eye Doctors
Rockville, Maryland, 20852, United States
Fraser Eye Care Center
Fraser, Michigan, 48026, United States
Twin Cities Eye Consultants
Coon Rapids, Minnesota, 55433, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017, United States
Moyes Eye Center
Kansas City, Missouri, 64154, United States
Center for Sight
Las Vegas, Nevada, 89145, United States
Carolina Eye Associates PA
Southern Pines, North Carolina, 28387, United States
Cleveland Eye Clinic
Brecksville, Ohio, 44141, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Cincinnati Eye / Apex Eye
Mason, Ohio, 45040, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066, United States
Texan Eye / Keystone Research
Austin, Texas, 78731, United States
Glaucoma Associates Of Texas
Dallas, Texas, 75231, United States
El Paso Eye Surgeons
El Paso, Texas, 79902, United States
Texas Eye Research Center
Hurst, Texas, 76054, United States
The Eye Institute of Utah
Salt Lake City, Utah, 84107, United States
Eye Centers Of Racine And Kenosha
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Project Lead, CDMA Surgical
Alcon Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2020
First Posted
September 17, 2020
Study Start
August 25, 2020
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
June 3, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share