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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Device: Hydrus Microstent; Procedure: Cataract surgery; Device: Monofocal IOL

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.

• Study Type: Interventional
• Enrollment (Estimated): 545
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alcon Call Center; Phone Number: 1-888-451-3937; Email: alcon.medinfo@alcon.com

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Completed
      • Coastal Vision
    • Sacramento, California, United States, 95815
      • Recruiting
      • Sacramento Eye Consultants
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Recruiting
      • Eye Center of Northern Colorado
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Recruiting
      • Jones Eye Center PC
  • Kansas
    • Overland Park, Kansas, United States, 66213
      • Not yet recruiting
      • Stiles Eyecare Excellence Cataracts and Glaucoma
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Not yet recruiting
      • Visionary Eye Doctors
  • Michigan
    • Fraser, Michigan, United States, 48026
      • Recruiting
      • Fraser Eye Care Center
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Recruiting
      • Twin Cities Eye Consultants
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Recruiting
      • Midwest Vision Research Foundation
    • Kansas City, Missouri, United States, 64154
      • Not yet recruiting
      • Moyes Eye Center
  • Nevada
    • Las Vegas, Nevada, United States, 89145
      • Recruiting
      • Center for Sight
  • North Carolina
    • Southern Pines, North Carolina, United States, 28387
      • Recruiting
      • Carolina Eye Associates PA
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Completed
      • Cleveland Eye Clinic
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • Cincinnati Eye Institute
    • Mason, Ohio, United States, 45040
      • Not yet recruiting
      • Cincinnati Eye / Apex Eye
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Not yet recruiting
      • Scott & Christie and Associates, PC
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • Texan Eye / Keystone Research
    • Dallas, Texas, United States, 75231
      • Not yet recruiting
      • Glaucoma Associates of Texas
    • El Paso, Texas, United States, 79902
      • Recruiting
      • El Paso Eye Surgeons
    • Hurst, Texas, United States, 76054
      • Recruiting
      • Texas Eye Research Center
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Not yet recruiting
      • The Eye Institute of Utah
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Recruiting
      • Eye Centers of Racine and Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hydrus Microstent; Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)

Device: Hydrus Microstent; 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.; Procedure: Cataract surgery; Cataract surgery performed using standard anesthesia and phacoemulsification techniques; Device: Monofocal IOL; Commercially available monofocal intraocular lens as determined by the investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of occurrence of intraoperative ocular adverse events	Intraoperative ocular adverse events as specified in the protocol include hyphema obscuring the surgeon's view, choroidal hemorrhage or effusion, choroidal detachment, significant iris injury or trauma, corneal abrasion, corneal edema, zonular dialysis, cyclodialysis, cyclodialysis cleft, iridodialysis, vitreous loss not associated with the cataract procedure, inadvertent perforation of the sclera, and Descemet's membrane detachment.	Day 0 operative
Rate of occurrence of sight threatening postoperative adverse events	Sight threatening, post-operative adverse events as specified in the protocol include endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection.	Up to Month 24
Rate of occurrence of other postoperative ocular adverse events	Other postoperative ocular adverse events as specified in the protocol include anterior uveitis/iritis, non-persistent & persistent, best corrected visual acuity (BCVA) loss of 2 lines or more, chronic pain, device migration, device obstruction, peripheral anterior synechiae (PAS), ocular secondary surgical interventions for intraocular pressure (IOP) or glaucoma management, hypotony at or after 1 month postop, hyphema, corneal opacification, corneal edema persisting or severe corneal edema, other retinal complications, elevated mean IOP >/=10 millimeters mercury (mmHg) vs screening, iris prolapse/wound incarceration, significant foreign body sensation at or after 3 months postop, surgical re-intervention, and worsening of visual field.	Up to Month 24

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Project Lead, CDMA Surgical, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: CP 18-001; GLI314-C003 (Other Identifier: Alcon Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes