Hydrus Microstent for Refractory Open-Angle Glaucoma (SUMMIT)

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

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

Study Overview

• Status: Completed
• Conditions: Open-angle Glaucoma
• Intervention / Treatment: Procedure: Ophthalmic surgery; Device: Hydrus Microstent

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.

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Barranquilla, Colombia, 080020
    • Clínica Oftalmológica
• Philippines
  • Makati City, Philippines, 1200
    • Asian Eye Institute
• Spain
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Eye Hospital
• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Vold Vision
  • California
    • Sacramento, California, United States, 95815
      • Sacramento Eye Consultants
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Eye Center of Northern Colorado
  • Florida
    • Ocala, Florida, United States, 34474
      • Ocala Eye
    • Venice, Florida, United States, 34283
      • Center for Sight
  • Kansas
    • Overland Park, Kansas, United States, 66213
      • Stiles Eyecare
  • Louisiana
    • Alexandria, Louisiana, United States, 71303
      • Louisiana Eye and Laser Center
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University in St. Louis Ophthalmology
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye
    • Dallas, Texas, United States, 75231
      • Glaucoma Associates of Texas
    • El Paso, Texas, United States, 79902
      • El Paso Eye Surgeons
    • Fort Worth, Texas, United States, 76102
      • Ophthalmology Associates
    • Houston, Texas, United States, 77030
      • Vale-Asche Russell Clinical Research Center
    • San Antonio, Texas, United States, 78229
      • R and R Research, LLC
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • The Eye Centers of Racine and Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Ophthalmic surgery; Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia; Device: Hydrus Microstent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Month 12

Collaborators and Investigators

• Sponsor: Ivantis, Inc.
• Investigators: Study Director: Clinical Project Lead, CRD Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures
• Other Study ID Numbers: CP 16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes