Hydrus Microstent for Refractory Open-Angle Glaucoma
- Conditions
- Open-angle Glaucoma
- Interventions
- Device: Hydrus MicrostentProcedure: Ophthalmic surgery
- Registration Number
- NCT03267134
- Lead Sponsor
- Ivantis, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hydrus Microstent Ophthalmic surgery 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. Hydrus Microstent 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.
- Primary Outcome Measures
Name Time Method 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 Baseline, Month 12 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in MDIOP at Month 12 Baseline, 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.
Trial Locations
- Locations (20)
Asian Eye Institute
🇵🇭Makati City, Philippines
Clínica Oftalmológica
🇨🇴Barranquilla, Colombia
Glaucoma Associates of Texas
🇺🇸Dallas, Texas, United States
Eye Center of Northern Colorado
🇺🇸Fort Collins, Colorado, United States
Center for Sight
🇺🇸Venice, Florida, United States
Ocala Eye
🇺🇸Ocala, Florida, United States
Stiles Eyecare
🇺🇸Overland Park, Kansas, United States
El Paso Eye Surgeons
🇺🇸El Paso, Texas, United States
Vold Vision
🇺🇸Fayetteville, Arkansas, United States
Louisiana Eye and Laser Center
🇺🇸Alexandria, Louisiana, United States
Washington University in St. Louis Ophthalmology
🇺🇸Saint Louis, Missouri, United States
Ophthalmology Associates
🇺🇸Fort Worth, Texas, United States
Scott & Christie and Associates
🇺🇸Cranberry Township, Pennsylvania, United States
The Eye Centers of Racine and Kenosha
🇺🇸Kenosha, Wisconsin, United States
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Manchester Royal Eye Hospital
🇬🇧Manchester, United Kingdom
Texan Eye
🇺🇸Austin, Texas, United States
Sacramento Eye Consultants
🇺🇸Sacramento, California, United States
R and R Research, LLC
🇺🇸San Antonio, Texas, United States
Vale-Asche Russell Clinical Research Center
🇺🇸Houston, Texas, United States