Hydrus® Microstent New Enrollment Post-Approval Study

Primary Open Angle Glaucoma Clinical Trial

— CONFIRM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04553523
• Other study ID #: CP 18-001
• Secondary ID: GLI314-C003
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: June 2028

Study information

• Verified date: May 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 545
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• 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

Locations

Country	Name	City	State
United States	Texan Eye / Keystone Research	Austin	Texas
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Midwest Vision Research Foundation	Chesterfield	Missouri
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Twin Cities Eye Consultants	Coon Rapids	Minnesota
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	Fraser Eye Care Center	Fraser	Michigan
United States	Texas Eye Research Center	Hurst	Texas
United States	Coastal Vision	Irvine	California
United States	Moyes Eye Center	Kansas City	Missouri
United States	Eye Centers Of Racine And Kenosha	Kenosha	Wisconsin
United States	Center for Sight	Las Vegas	Nevada
United States	Eye Center of Northern Colorado	Loveland	Colorado
United States	Cincinnati Eye / Apex Eye	Mason	Ohio
United States	Stiles Eyecare Excellence Cataracts and Glaucoma	Overland Park	Kansas
United States	Visionary Eye Doctors	Rockville	Maryland
United States	Sacramento Eye Consultants	Sacramento	California
United States	The Eye Institute of Utah	Salt Lake City	Utah
United States	Jones Eye Center PC	Sioux City	Iowa
United States	Carolina Eye Associates PA	Southern Pines	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 operative, up to Month 24 postoperative
Secondary	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.	Day 0 operative
Secondary	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.	Up to Month 24
Secondary	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.	Up to Month 24