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Hydrus® Microstent New Enrollment Post-Approval Study (CONFIRM)

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ClinicalTrials.gov Identifier: NCT04553523
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : December 20, 2022
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Device: Hydrus Microstent Procedure: Cataract surgery Device: Monofocal IOL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 545 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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

Primary Outcome Measures :
  1. Rate of occurrence of clinically significant device malposition associated with clinical sequelae [ Time Frame: Day 0 operative, up to Month 24 postoperative ]
    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.

Secondary Outcome Measures :
  1. Rate of occurrence of intraoperative ocular adverse events [ Time Frame: Day 0 operative ]
    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.

  2. Rate of occurrence of sight threatening postoperative adverse events [ Time Frame: Up to Month 24 ]
    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.

  3. Rate of occurrence of other postoperative ocular adverse events [ Time Frame: Up to Month 24 ]
    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.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553523

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Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com

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United States, California
Alcon Investigator 7977 Recruiting
Sacramento, California, United States, 95815
United States, Colorado
Alcon Investigator 4421 Active, not recruiting
Loveland, Colorado, United States, 80538
United States, Iowa
Alcon Investigator 6183 Recruiting
Sioux City, Iowa, United States, 51104
United States, Michigan
Alcon Investigator 7931 Recruiting
Fraser, Michigan, United States, 48026
United States, Minnesota
Alcon Investigator 8210 Recruiting
Coon Rapids, Minnesota, United States, 55433
United States, Missouri
Alcon Investigator 8208 Recruiting
Chesterfield, Missouri, United States, 63017
United States, Nevada
Alcon Investigator 8209 Recruiting
Las Vegas, Nevada, United States, 89145
United States, North Carolina
Alcon Investigator 8211 Recruiting
Southern Pines, North Carolina, United States, 28387
United States, Ohio
Alcon Investigator 6725 Recruiting
Cincinnati, Ohio, United States, 45242
United States, Texas
Alcon Investigator 5182 Recruiting
Austin, Texas, United States, 78731
Alcon Investigator 5231 Recruiting
El Paso, Texas, United States, 79902
Alcon Investigator 6185 Recruiting
Hurst, Texas, United States, 76054
United States, Wisconsin
Alcon Investigator 5471 Recruiting
Kenosha, Wisconsin, United States, 53142
Sponsors and Collaborators
Alcon Research
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Study Director: Clinical Project Lead, CDMA Surgical Alcon Research
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT04553523    
Other Study ID Numbers: CP 18-001
GLI314-C003 ( Other Identifier: Alcon Research )
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases