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

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

Tracking Information

• First Submitted Date: September 11, 2020
• First Posted Date: September 17, 2020
• Last Update Posted Date: December 20, 2022
• Actual Study Start Date: August 25, 2020
• Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 16, 2022)

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.

Original Primary Outcome Measures (submitted: September 11, 2020)

Occurrence of clinically significant device malposition [ Time Frame: 24 Months ]

Rate of occurrence of clinically significant device malposition associated with clinical sequelae

Current Secondary Outcome Measures (submitted: December 16, 2022)

• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: September 11, 2020)

• 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
• 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
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: September 11, 2020)

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)

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Primary Open Angle Glaucoma

Intervention

• 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

Study Arms

Experimental: Hydrus Microstent

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

Interventions:

• Device: Hydrus Microstent
• Procedure: Cataract surgery
• Device: Monofocal IOL

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 16, 2022): 545
• Original Estimated Enrollment (submitted: September 11, 2020): 330
• Estimated Study Completion Date: December 2026
• Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04553523
• Other Study ID Numbers: CP 18-001; GLI314-C003 ( Other Identifier: Alcon Research )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Alcon Research
• Original Responsible Party: Ivantis, Inc.
• Current Study Sponsor: Alcon Research
• Original Study Sponsor: Ivantis, Inc.
• Collaborators: Not Provided

Investigators

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

• PRS Account: Alcon Research
• Verification Date: December 2022