NCT01052558.
Trial name or title | GTS400 stent implantation in conjunction with cataract surgery in subjects with open‐angle glaucoma |
Methods |
Study design: parallel‐group RCT Unit of randomization: not reported Number randomized: not reported Unit of analysis: not reported Number analyzed: not reported Exclusions and losses to follow‐up: not reported Handling of missing data: not reported |
Participants |
Country: US Age: not reported Gender: not reported Inclusion criteria:
Exclusion criteria:
Diagnoses in participants: OAG |
Interventions |
Intervention 1: cataract surgery with subsequent implantation of GTS400 stents Intervention 2: cataract surgery Length of follow‐up: 1 year |
Outcomes |
Primary outcomes: proportion of participants with 12‐month diurnal IOP ≤ 21 mmHg without use of ocular hypotensive medications for ≥ 4 weeks prior to 12‐month visit Secondary outcomes: not reported Safety outcomes: not reported |
Starting date | 20 January 2010 |
Contact information | No contact details |
Notes |
Type of study: awaiting classification – described as "completed" on ClinicalTrials.gov Funding source: Glaukos Corporation, Laguna Hills, CA, USA provided funding/support Disclosures of interest: not reported Publication language: not reported Trial registration: NCT01052558 |