52
Participants
Start Date
November 25, 2017
Primary Completion Date
January 17, 2019
Study Completion Date
February 8, 2021
MINI DO636
"MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool.~The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach.~For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant.~Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT).~DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636)."
MINI SO636
"MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool.~The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach.~For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant.~Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT).~DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636)."
Maxivision Eye Hospital, Hyderabad
Clínica Oftalmológica del Caribe, Barranquilla
Panama Eye Center, Panama City
Lead Sponsor
iSTAR Medical
INDUSTRY