Hydrus® Microstent New Enrollment Post-Approval Study
- Conditions
- Primary Open Angle Glaucoma
- Interventions
- Device: Hydrus MicrostentProcedure: Cataract surgeryDevice: Monofocal IOL
- Registration Number
- NCT04553523
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 545
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hydrus Microstent Cataract surgery Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL) Hydrus Microstent Monofocal IOL Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL) Hydrus Microstent Hydrus Microstent Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)
- Primary Outcome Measures
Name Time Method Rate of occurrence of clinically significant device malposition associated with clinical sequelae 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
Name Time Method Rate of occurrence of sight threatening postoperative adverse events 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 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.
Rate of occurrence of intraoperative ocular adverse events 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.
Trial Locations
- Locations (22)
Jones Eye Center PC
🇺🇸Sioux City, Iowa, United States
Twin Cities Eye Consultants
🇺🇸Coon Rapids, Minnesota, United States
Midwest Vision Research Foundation
🇺🇸Chesterfield, Missouri, United States
Eye Centers Of Racine And Kenosha
🇺🇸Kenosha, Wisconsin, United States
Eye Center of Northern Colorado
🇺🇸Loveland, Colorado, United States
Stiles Eyecare Excellence Cataracts and Glaucoma
🇺🇸Overland Park, Kansas, United States
Coastal Vision
🇺🇸Irvine, California, United States
Visionary Eye Doctors
🇺🇸Rockville, Maryland, United States
Fraser Eye Care Center
🇺🇸Fraser, Michigan, United States
Carolina Eye Associates PA
🇺🇸Southern Pines, North Carolina, United States
Cleveland Eye Clinic
🇺🇸Brecksville, Ohio, United States
Cincinnati Eye / Apex Eye
🇺🇸Mason, Ohio, United States
Scott & Christie and Associates, PC
🇺🇸Cranberry Township, Pennsylvania, United States
Glaucoma Associates Of Texas
🇺🇸Dallas, Texas, United States
El Paso Eye Surgeons
🇺🇸El Paso, Texas, United States
Texas Eye Research Center
🇺🇸Hurst, Texas, United States
Sacramento Eye Consultants
🇺🇸Sacramento, California, United States
Moyes Eye Center
🇺🇸Kansas City, Missouri, United States
Texan Eye / Keystone Research
🇺🇸Austin, Texas, United States
Center for Sight
🇺🇸Las Vegas, Nevada, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
The Eye Institute of Utah
🇺🇸Salt Lake City, Utah, United States