NCT00326066.

Trial name or title	A Study of the Trabecular Micro‐bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension
Methods	Study design: parallel‐group RCT Unit of randomization: not reported Number randomized: 47 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: Vienna, Austria (Vienna Medical Hospital); Germany (Mainz University, Mainz; Augenklinik der Technischen Universitat, Munich; Universitats‐ Augenklinik, Wurzburg); Netherlands (The Netherlands Ophthalmic Research Institute, Amsterdam; Ophthalmic Clinic, Rotterdam); Spain (Clinico San Carlos, Madrid; Instituto Oftalmologico de Aragon, Zaragoza); Turkey (Beyoglu Eye Research and Education Hospital, Istanbul) Age: not reported; 18 years and older eligible Gender: not reported, both genders eligible Ethnicity: not reported Inclusion criteria: newly diagnosed with open‐angle glaucoma or ocular hypertension and not yet taking any glaucoma medications or recently diagnosed with mild open‐angle glaucoma and being treated with up to 2 glaucoma medications needing cataract surgery Exclusion criteria: angle‐closure glaucoma secondary glaucomas (except pseudoexfoliative and pigmentary), neovascular, uveitic or angle recession glaucoma previous glaucoma procedures (e.g., trabeculectomy, viscocanalostomy, argon laser trabeculoplasty, selective laser trabeculoplasty, shunt implant, collagen implant, cyclodestructive procedures) fellow eye already enrolled Equivalence of baseline characteristics: not reported Diagnoses in participants: open‐angle glaucoma or ocular hypertension and cataract
Interventions	Intervention 1: combined cataract surgery (phacoemulsification) and 2 iStent® implantations Intervention 2: cataract surgery (phacoemulsification) alone Study follow‐up: 24 months
Outcomes	Primary outcome: efficacy (reduction in IOP) Secondary outcomes: not reported Adverse events assessed: not reported Intervals at which outcomes assessed: not reported
Starting date	February 2005
Contact information	Study Director: Head of Clinical Affairs (Glaukos Corporation)
Notes	Type of study: ongoing Study period: enrolment from February 2005 to May 2013 Funding source: Glaukos Corporation Disclosures of interest: affiliation with Glaukos Corporation Publication language: English Subgroup analysis: none reported