Hydrus Microstent for Refractory Open-Angle Glaucoma

Open-angle Glaucoma Clinical Trial

— SUMMIT  

Official title:

The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial (Hydrus VII Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267134
• Other study ID #: CP 16-001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 16, 2022

Study information

• Verified date: December 2023
• Source: Ivantis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open-angle Glaucoma

Intervention

Device:
• Hydrus Microstent
Device implanted into the Schlemm's canal of the eye for the purpose of providing a natural outflow pathway for aqueous humor. The Hydrus Microstent is intended for lifetime use of the glaucoma patient.

Procedure:
• Ophthalmic surgery
Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia

Locations

Country	Name	City	State
Colombia	Clínica Oftalmológica	Barranquilla
Philippines	Asian Eye Institute	Makati City
Spain	Hospital Universitario Miguel Servet	Zaragoza
United Kingdom	Manchester Royal Eye Hospital	Manchester
United States	Louisiana Eye and Laser Center	Alexandria	Louisiana
United States	Texan Eye	Austin	Texas
United States	Scott & Christie and Associates	Cranberry Township	Pennsylvania
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	El Paso Eye Surgeons	El Paso	Texas
United States	Vold Vision	Fayetteville	Arkansas
United States	Eye Center of Northern Colorado	Fort Collins	Colorado
United States	Ophthalmology Associates	Fort Worth	Texas
United States	Vale-Asche Russell Clinical Research Center	Houston	Texas
United States	The Eye Centers of Racine and Kenosha	Kenosha	Wisconsin
United States	Ocala Eye	Ocala	Florida
United States	Stiles Eyecare	Overland Park	Kansas
United States	Sacramento Eye Consultants	Sacramento	California
United States	Washington University in St. Louis Ophthalmology	Saint Louis	Missouri
United States	R and R Research, LLC	San Antonio	Texas
United States	Center for Sight	Venice	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ivantis, Inc.

Countries where clinical trial is conducted

United States,  Colombia,  Philippines,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IOP will be measured using Goldmann Applanation tonometry. Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve MDIOP.	Baseline, Month 12
Secondary	Mean Change From Baseline in MDIOP at Month 12	IOP will be measured using Goldmann Applanation tonometry and recorded in millimeters mercury (mmHG). Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve MDIOP.	Baseline, Month 12