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. 2019 Mar 28;2019(3):CD012743. doi: 10.1002/14651858.CD012743.pub2

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:
  1. diagnosed with OAG in the study eye

  2. using 1–3 glaucoma medications

  3. able and willing to attend follow‐up visits for 2 years postoperation

  4. able and willing to sign informed consent


Exclusion criteria:
  1. PEXG and PG

  2. prior glaucoma surgery of any type


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