Safety and Efficacy Study of the Hydrus Aqueous Implant in Subjects With POAG

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ivantis, Inc.

Criteria

Inclusion Criteria:

• Elevated intraocular pressure (IOP)

• Diagnosis of mild to advanced open-angle glaucoma

• Shaffer Grade III

• Mental capacity to cooperate when undergoing operative and postoperative examination

• 18 years of age or older

• Provide written informed consent

• Willing and able to return to scheduled follow-up examinations for 24-months

Exclusion Criteria:

• Closed-angle and narrow-angle forms of glaucoma

• Secondary glaucomas

• Congenital or developmental glaucoma