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Hydrus(R) Microstent New Enrollment Post-Approval Study

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ClinicalTrials.gov Identifier: NCT04553523
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Ivantis, Inc.

Study Description
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Brief Summary:
To evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. This trial is a prospective, non-randomized, multicenter, single arm, post approval study. 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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Hydrus(R) 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 : May 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Single Arm
Subjects with mild to moderate POAG undergoing cataract surgery & implantation of the Hydrus Microstent
 Device: Hydrus Microstent
The Hydrus Microstent is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's canal, immediately following placement of a monofocal IOL


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of clinically significant device malposition [ Time Frame: 24 Months ]
    Rate of occurrence of clinically significant device malposition associated with clinical sequelae


Secondary Outcome Measures :
  1. Occurrence of intraoperative ocular adverse events [ Time Frame: 24 Months ]
    Rate of occurrence of intraoperative ocular adverse events including: 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, Descemet's membrane detachment

  2. Occurrence of sight threatening post-operative adverse events [ Time Frame: 24 Months ]
    Rate of occurrence of sight threatening, post-operative adverse events including: endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, aqueous misdirection

  3. Occurrence of other postoperative ocular adverse events [ Time Frame: 24 Months ]
    Rate of occurrence of other postop ocular adverse events including: anterior uveitis/iritis, non-persistent & persistent, BCVA loss of 2 lines or more, chronic pain, device migration, device obstruction, PAS, ocular secondary surgical interventions for 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 >/=10mmHg vs screening, iris prolapse/wound incarceration, significant foreign body sensation at or after 3 months postop, surgical re-intervention, worsening of visual field.


Other Outcome Measures:
  1. Occurrence of non-clinically significant device malposition [ Time Frame: 24 Months ]
    Rate of occurrence of device malposition that is not clinically significant (ie, does not result in clinical sequelae)


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

Inclusion Criteria:

  • An operable age-related cataract with BCVA of 20/40 or worse
  • Diagnosis of POAG treated with no more than 4 topical hypotensive medications
  • Optic nerve appearance characteristic of glaucoma
  • Medicated IOP </= 31mmHg

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
Contacts and Locations
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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


Contacts
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Contact: Richard Hope, MD 949-333-1310 rhope@ivantisinc.com

Locations
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United States, California
Sacramento Eye Consultants, A Medical Corporation Recruiting
Sacramento, California, United States, 95815
Contact: Jacob Brubaker, MD       jbrubaker@saceye.com   
United States, Colorado
Eye Center of Northern Colorado Recruiting
Fort Collins, Colorado, United States, 80528
Contact: Kent Bashford, MD       K.Bashford@eyecenternoco.com   
United States, Michigan
Fraser Eye Care Center Recruiting
Fraser, Michigan, United States, 48026
Contact: Mahdi Basha, MD       mahdib@frasereye.com   
United States, Minnesota
North Suburban Eye Specialists Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: George Wandling, MD       gwandling@nseyespecialists.com   
United States, Nevada
Center for Sight Recruiting
Las Vegas, Nevada, United States, 89145
Contact: Eva Liang, MD       evaliang11@gmail.com   
United States, North Carolina
Carolina Eye Associates Recruiting
Southern Pines, North Carolina, United States, 28387
Contact: Winston Garris, MD       winston.garris@carolinaeye.com   
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Anup Khatana, MD       akhatana@cvphealth.com   
United States, Texas
El Paso Eye Surgeons, PA Not yet recruiting
El Paso, Texas, United States, 79902
Contact: Mark Gallardo, MD       gallardomark@hotmail.com   
Texas Eye & Laser Center Recruiting
Hurst, Texas, United States, 76054
Contact: Jerry Hu, MD       jerryganghu@hotmail.com   
United States, Wisconsin
The Eye Centers of Racine and Kenosha LTD Not yet recruiting
Kenosha, Wisconsin, United States, 53142
Contact: Inder Paul Singh, MD       ipsingh@amazingeye.com   
Sponsors and Collaborators
Ivantis, Inc.
More Information
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Responsible Party: Ivantis, Inc.
ClinicalTrials.gov Identifier: NCT04553523    
Other Study ID Numbers: CP 18-001
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
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
Glaucoma
Ocular Hypertension
Eye Diseases