NCT01818115.

Trial name or title	A Prospective, Multi‐Center, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the Hydrus Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
Methods	Study design: parallel‐group RCT Unit of randomization: not reported Number randomized: 100 total; per group not reported Unit of analysis: not reported Number analyzed: not reported Exclusions and losses to follow‐up: not reported Power calculation: none reported
Participants	Country: Germany (2 sites), Italy (2 sites), Netherlands, Spain (2 sites) Age: not reported; 21 to 80 years eligible Gender: not reported, both genders eligible Ethnicity: not reported Inclusion criteria: POAG or PEXG operable, age‐related cataract eligible for phacoemulsification Exclusion criteria: closed‐angle and narrow angle forms of glaucoma secondary glaucoma, such as neovascular, uveitic, traumatic, steroid‐induced, or lens‐induced glaucoma associated with increased episcleral venous pressure congenital or developmental glaucoma Equivalence of baseline characteristics: not reported Diagnoses in participants: POAG or PEXG and cataract
Interventions	Intervention 1: combined cataract surgery (phacoemulsification) with IOL implantation and Hydrus Implant implantation Intervention 2: cataract surgery (phacoemulsification) with IOL implantation alone Study follow‐up: 24 months
Outcomes	Primary outcome: difference in proportion of participants with 20% reduction in mean diurnal IOP at 24 months following the wash‐out of all glaucoma medications Secondary outcomes: reduction in mean washed out IOP at 24 months change in BCVA from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart proportion of eyes with IOP > 5 mmHg to ≤ 19 mmHg following terminal washout diurnal IOP at 12 months following washout Adverse events assessed: not reported Intervals at which outcomes assessed: annual follow‐up up to 5 years
Starting date	January 2011
Contact information	Principal Investigator: Norbert Pfeiffer, MD (Universitatsmedizin Mainz)
Notes	Type of study: ongoing Study period: January 2011 to November 2014 Funding source: Ivantis, Inc. Disclosures of interest: affiliation with Ivantis, Inc. Publication language: English Subgroup analysis: none reported

IOL: intraocular lens; IOP: intraocular pressure; PEXG: pseudoexfoliation glaucoma; POAG: primary open‐angle glaucoma.