NCT01052558.

Trial name or title	A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos Trabecular Micro‐bypass Stent Model GTS400 in Conjunction With Cataract Surgery
Methods	Study design: parallel‐group RCT Unit of randomization: not reported Number randomized: estimated 500; 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: USA (22 sites) Age: not reported; 18 to 90 years eligible Gender: not reported, both genders eligible Ethnicity: not reported Inclusion criteria: open‐angle glaucoma in study eye taking 1 to 3 glaucoma medications able and willing to attend follow‐up visits for two years able and willing to sign informed consent Exclusion criteria: pseudoexfoliative or pigmentary glaucoma previous glaucoma surgery of any type Equivalence of baseline characteristics: not reported Diagnoses in participants: open‐angle glaucoma and cataract
Interventions	Intervention 1: combined cataract surgery (phacoemulsification) and iStent® implantation Intervention 2: cataract surgery (phacoemulsification) alone Study follow‐up: 12 months
Outcomes	Primary outcome: proportion of participants with 12 month diurnal IOP ≤ 21 mmHg without use of ocular hypotensive medications for 4 weeks or more prior to 12 month visit Secondary outcomes: not reported Adverse events assessed: not reported Intervals at which outcomes assessed: not reported
Starting date	January 2010
Contact information	Study Director: Jeff Wells, PharmD, MBA (Glaukos Corporation) Study Chair: Jay Katz, MD (Wills Eye Institute; Thomas Jefferson University)
Notes	Type of study: ongoing Study period: enrolment from January 2010 to September 2013 Funding source: Glaukos Corporation Disclosures of interest: affiliation with Glaukos Corporation Publication language: English Subgroup analysis: none reported