Hydrus Microstent for Refractory Open-Angle Glaucoma

Not Applicable

Completed

• Conditions: Open-angle Glaucoma

• 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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Status Verified: 2023-12
• Disposition First Submitted: 2023-12-11
• Last Update Submitted: 2023-12-12
• Disposition First Posted: 2023-12-14
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

Vold Vision; 🇺🇸 Fayetteville, Arkansas, United States

Sacramento Eye Consultants; 🇺🇸 Sacramento, California, United States

Eye Center of Northern Colorado; 🇺🇸 Fort Collins, Colorado, United States

Ocala Eye; 🇺🇸 Ocala, Florida, United States

Center for Sight; 🇺🇸 Venice, Florida, United States

Stiles Eyecare; 🇺🇸 Overland Park, Kansas, United States

Louisiana Eye and Laser Center; 🇺🇸 Alexandria, Louisiana, United States

Washington University in St. Louis Ophthalmology; 🇺🇸 Saint Louis, Missouri, United States

Scott & Christie and Associates; 🇺🇸 Cranberry Township, Pennsylvania, United States

Texan Eye; 🇺🇸 Austin, Texas, United States

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