Hydrus Microstent for Refractory Open-Angle Glaucoma

Ivantis, Inc.217 enrolled

Overview

The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.

Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

217

Conditions

Open-angle Glaucoma

Interventions

Hydrus MicrostentDEVICE

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 surgeryPROCEDURE

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

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Open-angle glaucoma with optic nerve pathology; * BCVA of 20/80 or better in study eye; * Refractory glaucoma; * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma; * Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma; * Pre-perimetric glaucoma; * Ocular hypertension * Shallow or flat anterior chamber; * Other protocol-specified exclusion criteria may apply.

Locations (20)

Vold Vision

Fayetteville, Arkansas, United States

Sacramento Eye Consultants

Sacramento, California, United States

Outcomes

Primary Outcomes

Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline

Intraocular pressure was measured using Goldmann Applanation tonometry. Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure.

Time frame: Baseline, Month 12

Secondary Outcomes

Mean Change From Baseline in MDIOP at Month 12

Intraocular pressure was measured using Goldmann Applanation tonometry and recorded in millimeters mercury (mmHG). Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure. A negative number represents a reduction from baseline. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure.

Time frame: Baseline, Month 12

Data from ClinicalTrials.gov

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