Hydrus Microstent for Refractory Open-Angle Glaucoma

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.

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.

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.