NCT05198297

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

January 3, 2022

Last Update Submit

January 10, 2025

Conditions

Open Angle GlaucomaPrimary Open Angle GlaucomaPseudoexfoliation GlaucomaPigmentary Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects (Responders) with unmedicated DIOP greater than 6 mmHg and less than or equal to 21 mmHg with a reduction of greater than or equal to 20% from baseline and absence of secondary glaucoma surgery or loss of light perception

    Intraocular pressure (IOP) will be measured using Goldmann tonometry. Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure (DIOP). Baseline is defined as post ocular hypotensive medication washout and prior to Day 0, day of surgery. This is a co-primary endpoint. No hypothesis testing is prespecified.

    Baseline, Month 12 postoperative

Secondary Outcomes (1)

  • Mean Change in Unmedicated DIOP From Baseline to Month 12 and Absence of Secondary Glaucoma Surgery or Loss of Light Perception

    Baseline, Month 12 postoperative

Study Arms (1)

Hydrus Microstent

EXPERIMENTAL

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.

Device: Hydrus MicrostentProcedure: Ophthalmic surgery

Interventions

Hydrus MicrostentDEVICE

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.

Hydrus Microstent
Ophthalmic surgeryPROCEDURE

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

Hydrus Microstent

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Vold Vision PLLC

Bentonville, Arkansas, 72712, United States

Location

The Eye Clinic of Florida

Zephyrhills, Florida, 33542, United States

Location

Fraser Eye Care Center

Fraser, Michigan, 48026, United States

Location

Cincinnati Eye / Apex Eye

Mason, Ohio, 45040, United States

Location

Eye Centers Of Racine And Kenosha

Kenosha, Wisconsin, 53142, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleExfoliation Syndrome

Interventions

Ophthalmologic Surgical Procedures

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesIris DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Sr. Clinical Project Lead, Surgical

    Alcon Research, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 20, 2022

Study Start

December 13, 2021

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

January 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)