Clinical trial NCT04553523: Hydrus® Microstent New Enrollment Post-Approval Study
Official title: The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Open Angle Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-09-17
Enrollment: 545
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Primary outcomes:
measure: Rate of occurrence of clinically significant device malposition associated with clinical sequelae
timeFrame: Day 0 operative, up to Month 24 postoperative
Secondary outcomes:
measure: Rate of occurrence of intraoperative ocular adverse events
timeFrame: Day 0 operative
measure: Rate of occurrence of sight threatening postoperative adverse events
timeFrame: Up to Month 24
measure: Rate of occurrence of other postoperative ocular adverse events
timeFrame: Up to Month 24
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Coastal Vision
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants
state: California
city: Loveland
country: United States
facility: Eye Center of Northern Colorado
state: Colorado
city: Sioux City
country: United States
facility: Jones Eye Center PC
state: Iowa
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence Cataracts and Glaucoma
state: Kansas
city: Rockville
country: United States
facility: Visionary Eye Doctors
state: Maryland
city: Fraser
country: United States
facility: Fraser Eye Care Center
state: Michigan
city: Coon Rapids
country: United States
facility: Twin Cities Eye Consultants
state: Minnesota
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation
state: Missouri
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Las Vegas
country: United States
facility: Center for Sight
state: Nevada
city: Southern Pines
country: United States
facility: Carolina Eye Associates PA
state: North Carolina
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Mason
country: United States
facility: Cincinnati Eye / Apex Eye
state: Ohio
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Austin
country: United States
facility: Texan Eye / Keystone Research
state: Texas
city: Dallas
country: United States
facility: Glaucoma Associates Of Texas
state: Texas
city: El Paso
country: United States
facility: El Paso Eye Surgeons
state: Texas
city: Hurst
country: United States
facility: Texas Eye Research Center
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
city: Kenosha
country: United States
facility: Eye Centers Of Racine And Kenosha
state: Wisconsin
Study officials:
affiliation: Alcon Research
name: Clinical Project Lead, CDMA Surgical
role: STUDY_DIRECTOR
References: