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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

Study Clinical 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)
 Phase 1 2 Post market 3
 Control Single arm Single arm Single arm Randomized, 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) 5 2 2 2
 Enrolled patients 23 72 100 889 (estimated)
 Key inclusion criteria Age: 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 criteria Need 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 enrollment Previous conjunctival incisional ophthalmic surgery, anticipated need for additional ocular surgery during the study
 Primary outcome IOP reduction relative to baseline at 12 months >  20% IOP reduction from baseline at 12 months without increasing the number of glaucoma medications
 Study start October 2007 June 2011 April 2014 August 2013
 Primary completion November 2016 December 2016 November 2017 November 2018
 Completion January 2017 January 2017 November 2017 November 2019 (estimated)
  1. IOP = intraocular pressure