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NCT Number: NCT04553523

Hydrus® Microstent New Enrollment Post-Approval Study

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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coastal Vision, Irvine, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrus Microstent

Device

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.

cataract surgery

Procedure

Cataract surgery performed using standard anesthesia and phacoemulsification techniques

Monofocal IOL

Device

Commercially available monofocal intraocular lens as determined by the investigator

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alcon Call Center

CONTACT

[email protected]

1-888-451-3937

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial

Acronym: CONFIRM

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2020
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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