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. 2015 Dec 1;2015(12):CD010472. doi: 10.1002/14651858.CD010472.pub2

JPRN‐UMIN000008981.

Trial name or title Prospective comparative study of the Ex‐PRESS mini glaucoma shunt with standard trabeculectomy.
Methods Study design: "interventional, randomized, parallel, open label clinical trial"
Number randomized: 200 participants (number of eyes not reported) total; not reported by intervention group
Unit of analysis: not reported
Power calculation: not reported
Participants Country: Japan
Inclusion criteria: open‐angle glaucoma; participants to be 20 years and older
Exclusion Criteria: angle‐closure glaucoma; uveitis
Interventions Intervention 1: trabeculectomy + Ex‐PRESS mini shunt implantation
Intervention 2: trabeculectomy
Length of follow‐up: planned: not reported
Outcomes Primary outcome, as defined in study reports: IOP reduction
 Secondary outcomes, as defined in study reports: not reported
 Adverse events reported: not reported
Intervals at which outcomes assessed: not reported
Starting date 1 October 2012
Contact information Hideki Mochizuki: mochizuki‐h@hiroshima‐u.ac.jp
1‐2‐3 Kasumi Minamiku Hiroshima, Japan
Hiroshima University Dept. of Ophthalmology
Notes Funding source: self funding
Last updated: 3 June 2014
This study is currently recruiting participants.