NCT01085357.

Trial name or title	A Prospective, Randomized, Comparative, MultiCenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients With Open Angle Glaucoma Undergoing Cataract Surgery
Methods	Study design: parallel‐group RCT Unit of randomization: not reported Number randomized: 897 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: USA (22 sites) Age: not reported; 45 years and older eligible Gender: not reported, both genders eligible Ethnicity: not reported Inclusion criteria: POAG operable age‐related cataract mean diurnal unmedicated IOP of 21 to 33 mmHg normal anterior chamber angle anatomy at site of implantation Exclusion criteria: acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma use of more than three ocular hypotensive medications (combination medications count as two medications) significant risk associated with washout of ocular hypotensive medication previous glaucoma surgery (with exception of laser treatments to the trabecular meshwork) previous corneal surgery clinically significant ocular pathology, other than cataract and glaucoma Equivalence of baseline characteristics: not reported Diagnoses in participants: POAG and cataract
Interventions	Intervention 1: combined cataract surgery (phacoemulsification) and CyPass Micro‐Stent implantation Intervention 2: cataract surgery (phacoemulsification) alone Study follow‐up: 24 months
Outcomes	Primary outcome: proportion of eyes with ≥ 20% decrease in IOP from baseline to the hypotensive medication‐free 24‐month postoperative examination Secondary outcomes: mean change in IOP between baseline and hypotensive medication‐free 24‐month postoperative examination proportion of eyes with postoperative IOP ≥ 6 and ≤ 18 mmHg, as measured by Goldmann tonometry, at the hypotensive medication‐free 24‐month postoperative examination Adverse events assessed: not reported Intervals at which outcomes assessed: not reported
Starting date	September 2009
Contact information	None provided
Notes	Type of study: ongoing Study period: September 2009 to March 2015 Funding source: Transcend Medical, Inc. Disclosures of interest: affiliation with Transcend Medical, Inc. Publication language: English Subgroup analysis: none reported