MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

NACompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

November 25, 2017

Primary Completion Date

January 17, 2019

Study Completion Date

February 8, 2021

Conditions
Open Angle Glaucoma
Interventions
DEVICE

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)."

DEVICE

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)."

Trial Locations (3)

500034

Maxivision Eye Hospital, Hyderabad

Unknown

Clínica Oftalmológica del Caribe, Barranquilla

Panama Eye Center, Panama City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

iSTAR Medical

INDUSTRY