Hydrus(R) Microstent New Enrollment Post-Approval Study

Sponsor

Ivantis, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04553523

Collaborator

(none)

330

Enrollment

Locations

Arm

75.2

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. This trial is a prospective, non-randomized, multicenter, single arm, post approval study. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma	Device: Hydrus Microstent	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

330 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 25, 2020

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Hydrus Microstent Eyes with Hydrus Microstent implantation	Device: Hydrus Microstent The Hydrus Microstent is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's canal, immediately following placement of a monofocal IOL

Arm

Intervention/Treatment

Other: Hydrus Microstent

Eyes with Hydrus Microstent implantation

Device: Hydrus Microstent

The Hydrus Microstent is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's canal, immediately following placement of a monofocal IOL

Outcome Measures

Primary Outcome Measures

Rate of occurrence of clinically significant device malposition associated with clinical sequelae will be assessed [Up to 24 Months]
The position of the implant will be assessed visually intraoperatively and at each postoperative follow-up visit

Secondary Outcome Measures

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, Descemet's membrane detachment
Rate of occurrence of sight threatening post-operative adverse events [Up to 24 Months]
Sight threatening, post-operative adverse events as specified in the protocol include: endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, aqueous misdirection
Rate of occurrence of other postoperative ocular adverse events [Up to 24 Months]
Other postop ocular adverse events as specified in the protocol include: anterior uveitis/iritis, non-persistent & persistent, BCVA loss of 2 lines or more, chronic pain, device migration, device obstruction, PAS, ocular secondary surgical interventions for 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 >/=10mmHg vs screening, iris prolapse/wound incarceration, significant foreign body sensation at or after 3 months postop, surgical re-intervention, worsening of visual field.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

An operable age-related cataract with BCVA of 20/40 or worse
Diagnosis of POAG treated with no more than 4 topical hypotensive medications
Optic nerve appearance characteristic of glaucoma
Medicated IOP </= 31mmHg

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Vision	Orange	California	United States	92868
2	Sacramento Eye Consultants, A Medical Corporation	Sacramento	California	United States	95815
3	Eye Center of Northern Colorado	Fort Collins	Colorado	United States	80528
4	Jones Eye Clinic & Surgery Center	Sioux City	Iowa	United States	51104
5	Fraser Eye Care Center	Fraser	Michigan	United States	48026
6	North Suburban Eye Specialists	Coon Rapids	Minnesota	United States	55433
7	Midwest Vision Research Foundation	Chesterfield	Missouri	United States	63017
8	Center for Sight	Las Vegas	Nevada	United States	89145
9	Carolina Eye Associates	Southern Pines	North Carolina	United States	28387
10	Cleveland Eye Clinic	Brecksville	Ohio	United States	44141
11	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242
12	Keystone Research	Austin	Texas	United States	78731
13	El Paso Eye Surgeons, PA	El Paso	Texas	United States	79902
14	Texas Eye & Laser Center	Hurst	Texas	United States	76054
15	The Eye Centers of Racine and Kenosha LTD	Kenosha	Wisconsin	United States	53142

Sponsors and Collaborators

Ivantis, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ivantis, Inc.

ClinicalTrials.gov Identifier:

NCT04553523

Other Study ID Numbers:

CP 18-001

First Posted:

Sep 17, 2020

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Glaucoma, Open-Angle

Study Results

No Results Posted as of Jul 26, 2022