CompletedNot Applicable

Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.

Germany, Italy, Netherlands100 participantsStarted 2011-01

Plain-language summary

The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.

Who can participate

Age range21 Years – 80 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: * Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma. * Operable, age-related cataract eligible for phacoemulsification. Exclusion Criteria: * Closed Angle and narrow angle forms of Glaucoma. * Other Secondary Glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma.

What they're measuring

Difference in proportion of subjects with 20% reduction in mean diurnal Intraocular Pressure (IOP) at 24 months following the wash-out of all glaucoma medications.

Timeframe: 24 months

Trial details

NCT IDNCT01818115

SponsorIvantis, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

View on ClinicalTrials.gov More Primary Open Angle Glaucoma trials