CompletedPhase 1/2

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

Austria, Germany, Mexico120 participantsStarted 2010-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in IOP of study eye between each randomized group

Timeframe: Baseline & One year

Trial details

NCT IDNCT03065036

SponsorIvantis, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Primary Open Angle Glaucoma trials