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Hydrus® Microstent New Enrollment Post-Approval Study
NCT04553523 · Alcon Research
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
About this study
Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.
This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.
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.
Study design
Enrollment target: 545 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-08-25
Estimated completion: 2028-06
Last updated: 2025-06-03
Interventions
Device: Hydrus MicrostentProcedure: Cataract surgeryDevice: Monofocal IOL
Primary outcomes
- • Rate of occurrence of clinically significant device malposition associated with clinical sequelae (Day 0 operative, up to Month 24 postoperative)
Sponsor
Alcon Research · industry
Contacts & investigators
ContactAlcon Call Center · contact · alcon.medinfo@alcon.com · 1-888-451-3937
InvestigatorClinical Project Lead, CDMA Surgical · study_director, Alcon Research
All locations (22)
Coastal VisionCompleted
Irvine, California, United States
Sacramento Eye ConsultantsRecruiting
Sacramento, California, United States
Eye Center of Northern ColoradoRecruiting
Loveland, Colorado, United States
Jones Eye Center PCRecruiting
Sioux City, Iowa, United States
Stiles Eyecare Excellence Cataracts and GlaucomaNot Yet Recruiting
Overland Park, Kansas, United States
Visionary Eye DoctorsNot Yet Recruiting
Rockville, Maryland, United States
Fraser Eye Care CenterRecruiting
Fraser, Michigan, United States
Twin Cities Eye ConsultantsRecruiting
Coon Rapids, Minnesota, United States
Midwest Vision Research FoundationRecruiting
Chesterfield, Missouri, United States
Moyes Eye CenterNot Yet Recruiting
Kansas City, Missouri, United States
Center for SightRecruiting
Las Vegas, Nevada, United States
Carolina Eye Associates PARecruiting
Southern Pines, North Carolina, United States
Cleveland Eye ClinicCompleted
Brecksville, Ohio, United States
Cincinnati Eye InstituteRecruiting
Cincinnati, Ohio, United States
Cincinnati Eye / Apex EyeNot Yet Recruiting
Mason, Ohio, United States
Scott & Christie and Associates, PCNot Yet Recruiting
Cranberry Township, Pennsylvania, United States
Texan Eye / Keystone ResearchRecruiting
Austin, Texas, United States
Glaucoma Associates Of TexasNot Yet Recruiting
Dallas, Texas, United States
El Paso Eye SurgeonsRecruiting
El Paso, Texas, United States
Texas Eye Research CenterRecruiting
Hurst, Texas, United States
The Eye Institute of UtahNot Yet Recruiting
Salt Lake City, Utah, United States
Eye Centers Of Racine And KenoshaRecruiting
Kenosha, Wisconsin, United States