Clinical trial NCT03267134: Hydrus Microstent for Refractory Open-Angle Glaucoma
Official title: The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial (Hydrus VII Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open-angle Glaucoma
Keywords: Glaucoma
Lead sponsor: Ivantis, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-30
Enrollment: 217
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Open-angle glaucoma with optic nerve pathology;
* Best Corrected Visual Acuity 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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Mean Change From Baseline in MDIOP at Month 12
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Sacramento
country: United States
facility: Sacramento Eye Consultants
state: California
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado
state: Colorado
city: Ocala
country: United States
facility: Ocala Eye
state: Florida
city: Venice
country: United States
facility: Center for Sight
state: Florida
city: Overland Park
country: United States
facility: Stiles Eyecare
state: Kansas
city: Alexandria
country: United States
facility: Louisiana Eye and Laser Center
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University in St. Louis Ophthalmology
state: Missouri
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates
state: Pennsylvania
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: El Paso
country: United States
facility: El Paso Eye Surgeons
state: Texas
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
city: Houston
country: United States
facility: Vale-Asche Russell Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: R and R Research, LLC
state: Texas
city: Kenosha
country: United States
facility: The Eye Centers of Racine and Kenosha
state: Wisconsin
city: Barranquilla
country: Colombia
facility: Clínica Oftalmológica
city: Makati City
country: Philippines
facility: Asian Eye Institute
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Project Lead, CRD Surgical
role: STUDY_DIRECTOR
References: