Hydrus Microstent for Refractory Open-Angle Glaucoma
SUMMIT
The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial (Hydrus VII Study)
1 other identifier
interventional
217
5 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
20 active sites
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
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 22, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2022
CompletedResults Posted
Study results publicly available
January 14, 2026
CompletedJanuary 14, 2026
December 1, 2025
5.4 years
August 22, 2017
December 1, 2025
December 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Mean Change From Baseline in MDIOP at Month 12
Baseline, Month 12
Study Arms (1)
Hydrus Microstent
EXPERIMENTALHydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted.
Interventions
Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia
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.
Eligibility Criteria
You may qualify if:
- Open-angle glaucoma with optic nerve pathology;
- BCVA of 20/80 or better in study eye;
- Refractory glaucoma;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ivantis, Inc.lead
Study Sites (20)
Vold Vision
Fayetteville, Arkansas, 72704, United States
Sacramento Eye Consultants
Sacramento, California, 95815, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, 80528, United States
Ocala Eye
Ocala, Florida, 34474, United States
Center for Sight
Venice, Florida, 34283, United States
Stiles Eyecare
Overland Park, Kansas, 66213, United States
Louisiana Eye and Laser Center
Alexandria, Louisiana, 71303, United States
Washington University in St. Louis Ophthalmology
St Louis, Missouri, 63110, United States
Scott & Christie and Associates
Cranberry Township, Pennsylvania, 16066, United States
Texan Eye
Austin, Texas, 78731, United States
Glaucoma Associates of Texas
Dallas, Texas, 75231, United States
El Paso Eye Surgeons
El Paso, Texas, 79902, United States
Ophthalmology Associates
Fort Worth, Texas, 76102, United States
Vale-Asche Russell Clinical Research Center
Houston, Texas, 77030, United States
R and R Research, LLC
San Antonio, Texas, 78229, United States
The Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, 53142, United States
Clínica Oftalmológica
Barranquilla, 080020, Colombia
Asian Eye Institute
Makati City, 1200, Philippines
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Manchester Royal Eye Hospital
Manchester, M13 9WL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Lead, CRD Surgical
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Clinical Project Lead, CRD Surgical
Alcon Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
August 22, 2017
First Posted
August 30, 2017
Study Start
August 1, 2017
Primary Completion
December 16, 2022
Study Completion
December 16, 2022
Last Updated
January 14, 2026
Results First Posted
January 14, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share