An interventional study of Hydrus Microstent and Cataract surgery in Primary Open Angle Glaucoma, sponsored by Alcon Research. Recruiting at 22 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
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.
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.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 545 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
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Exclusion Criteria:
Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)
Device: Hydrus Microstent · Procedure: Cataract surgery · Device: Monofocal IOL
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 performed using standard anesthesia and phacoemulsification techniques
Commercially available monofocal intraocular lens as determined by the investigator
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.
Time frame: Day 0 operative, up to Month 24 postoperative
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Month 24
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Plan to share: No
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