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

Primary Purpose

Primary Open Angle Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrus Microstent
Cataract surgery
Monofocal IOL
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Coastal Vision
  • Sacramento Eye ConsultantsRecruiting
  • Eye Center of Northern ColoradoRecruiting
  • Jones Eye Center PCRecruiting
  • Stiles Eyecare Excellence Cataracts and Glaucoma
  • Visionary Eye Doctors
  • Fraser Eye Care CenterRecruiting
  • Twin Cities Eye ConsultantsRecruiting
  • Midwest Vision Research FoundationRecruiting
  • Moyes Eye Center
  • Center for SightRecruiting
  • Carolina Eye Associates PARecruiting
  • Cleveland Eye Clinic
  • Cincinnati Eye InstituteRecruiting
  • Cincinnati Eye / Apex Eye
  • Scott & Christie and Associates, PC
  • Texan Eye / Keystone ResearchRecruiting
  • Glaucoma Associates Of Texas
  • El Paso Eye SurgeonsRecruiting
  • Texas Eye Research CenterRecruiting
  • The Eye Institute of Utah
  • Eye Centers Of Racine And KenoshaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydrus Microstent

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 11, 2020
Last Updated
September 20, 2023
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04553523
Brief Title
Hydrus® Microstent New Enrollment Post-Approval Study
Acronym
CONFIRM
Official Title
The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
545 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydrus Microstent
Arm Type
Experimental
Arm Description
Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)
Intervention Type
Device
Intervention Name(s)
Hydrus Microstent
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Cataract surgery performed using standard anesthesia and phacoemulsification techniques
Intervention Type
Device
Intervention Name(s)
Monofocal IOL
Intervention Description
Commercially available monofocal intraocular lens as determined by the investigator
Primary Outcome Measure Information:
Title
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
Description
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
Secondary Outcome Measure Information:
Title
Rate of occurrence of intraoperative ocular adverse events
Description
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
Title
Rate of occurrence of sight threatening postoperative adverse events
Description
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
Title
Rate of occurrence of other postoperative ocular adverse events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alcon Call Center
Phone
1-888-451-3937
Email
alcon.medinfo@alcon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Project Lead, CDMA Surgical
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Vision
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Completed
Facility Name
Sacramento Eye Consultants
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Name
Eye Center of Northern Colorado
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Individual Site Status
Recruiting
Facility Name
Jones Eye Center PC
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Individual Site Status
Recruiting
Facility Name
Stiles Eyecare Excellence Cataracts and Glaucoma
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Visionary Eye Doctors
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Fraser Eye Care Center
City
Fraser
State/Province
Michigan
ZIP/Postal Code
48026
Country
United States
Individual Site Status
Recruiting
Facility Name
Twin Cities Eye Consultants
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Vision Research Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Name
Moyes Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Center for Sight
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Eye Associates PA
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Individual Site Status
Completed
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Eye / Apex Eye
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Texan Eye / Keystone Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Name
Glaucoma Associates Of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
El Paso Eye Surgeons
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Eye Research Center
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Individual Site Status
Recruiting
Facility Name
The Eye Institute of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Eye Centers Of Racine And Kenosha
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hydrus® Microstent New Enrollment Post-Approval Study

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