Received: 3 August 2019
Accepted: 17 October 2019
First Online: 15 November 2019
Ethics approval and consent to participate
: The following statements refer to the original, published studies discussed in this review. All animal studies were authorized by the University of Miami Animal Care and Use Committee. All feasibility studies in humans were authorized by the appropriate government ethics committees. In France, approval was granted by the Agence Francaise de Sécurité Sanitaire des Produits de Santé and later by the Agence Nationale de Sécurité du Médicament et des Produits de Santé. In the Dominican Republic, approval was granted by the Dominican Republic National Counsel of Bioethics and Health. Local hospital-based ethics committee approvals were also obtained where required. MicroShunt clinical studies were conducted in accordance with the Declaration of Helsinki, the requirements for medical device investigations as presented in EN/ISO 14155 (2011), and applicable local regulatory requirements. All patients provided signed, written informed consent.
: Not applicable.
: OS, LP, and RA are employees of Santen Inc. PP is a consultant for protocol development and Medical Monitor for the MicroShunt FDA study (NCT01881425).