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Table 1 Complete and ongoing MicroShunt clinical studies

From: Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review

StudyClinical study of the safety and performance of the Miami InnFocus Drainage Implant to relieve glaucoma symptoms [12]Safety and performance of the Miami InnFocus Drainage Implant (MIDI Arrow) glaucoma drainage implant [11]Postmarket study of the InnFocus MicroShunt [10]InnFocus MicroShunt Versus Trabeculectomy Study (IMS) [13]
 NCT number (other study ID)NCT00772330 (INN003)NCT01563237 (INN004)NCT02177123 (INN007)NCT01881425 (INN005)
 Phase12Post market3
 ControlSingle armSingle armSingle armRandomized, parallel assignment, single masked
 Center(s)1 (Dominican Republic)1 (France)6 (France, the Netherlands, Spain, Switzerland)29 (France, Italy, the Netherlands, Spain, the UK, the USA)
 Follow up (years)5222
 Enrolled patients2372100889 (estimated)
 Key inclusion criteriaAge: 18–85 years
IOP: ≥ 18 and ≤ 40 mmHg inadequately controlled on tolerated medical therapy
Age: 18–85 years
IOP: ≥ 18 and ≤ 35 mmHg on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery
Age: 40–85 years
IOP: ≥ 15 and ≤ 40 mmHg on maximum tolerated medical therapy
 Key exclusion criteriaNeed for glaucoma surgery combined with other ocular procedures other than cataract surgery or anticipated need for
additional ocular surgery during the study
Previous incisional ophthalmic surgery (excluding uncomplicated cataract surgery), or argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollmentPrevious conjunctival incisional ophthalmic surgery, anticipated need for additional ocular surgery during the study
 Primary outcomeIOP reduction relative to baseline at 12 months>  20% IOP reduction from baseline at 12 months without increasing the number of glaucoma medications
 Study startOctober 2007June 2011April 2014August 2013
 Primary completionNovember 2016December 2016November 2017November 2018
 CompletionJanuary 2017January 2017November 2017November 2019 (estimated)
  1. IOP = intraocular pressure