Safety and Effectiveness of the Hydrus Microstent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent for lowering intraocular pressure (IOP) in pseudophakic patients with open-angle glaucoma for whom IOP is not sufficiently controlled on topical hypotensive medication and prior to incisional glaucoma surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)

NCT01539239

Primary Open Angle Glaucoma

COMPLETED NA

Hydrus Microstent for Refractory Open-Angle Glaucoma

NCT03267134

Open-angle Glaucoma

COMPLETED NA

Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma

NCT05583591

Open Angle Glaucoma

TERMINATED NA

Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty

NCT07073937

Glaucoma, Open Angle MIGS Minimally Invasive Glaucoma Surgery +6 more

ENROLLING_BY_INVITATION

Efficacy of Surgical Systems in Combination With Phacoemulsification: a Retrospective Analysis

NCT06953349

Open-Angle Glaucoma

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Qualified subjects will undergo ocular hypotensive medication washout prior to implantation with the Hydrus Microstent. Following implantation on Day 0, subjects will attend 8 scheduled postoperative visits: Day 1, Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.

A decision to terminate the study was made by the Sponsor arising from challenges with enrollment of the target study population, leading to suspension of enrollment and revision of the follow-up period to 12 months. The total duration of participation for each subject was approximately 13 months including the medication washout prior to implantation.

This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open Angle Glaucoma Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Pigmentary Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hydrus Microstent

Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted.

Group Type EXPERIMENTAL

Hydrus Microstent

Intervention Type DEVICE

Minimally invasive glaucoma surgery device implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient.

Ophthalmic surgery

Intervention Type PROCEDURE

Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hydrus Microstent

Minimally invasive glaucoma surgery device implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient.

Intervention Type DEVICE

Ophthalmic surgery

Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Early or moderate glaucomatous optic nerve damage;
* Uncomplicated cataract surgery with well centered posterior chamber IOL greater than or equal to 365 days prior to the screening visit;
* Inadequately controlled IOP;
* Shaffer angle grade III-IV in all four quadrants;
* Age appropriate minimum central endothelial cell density;

Exclusion Criteria

* Diagnosis of acute angle closure, chronic angle closure, or congenital, malignant, or developmental glaucoma;
* Requires oral hypotensive medications;
* Shallow or flat anterior chamber;
* Prior glaucoma surgery;
* Ocular hypertension;

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No