Open Angle Glaucoma
Conditions
Brief summary
The study will evaluate the efficacy and safety of MINIject 636 and IOP lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery. The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.
Interventions
DEVICEMINI 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).
DEVICEMINI 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).
Sponsors
iSTAR Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
26 patients enrolled into first arm, when enrolment completed, an additional 26 patients enrolled into second arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier. * Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System. * Glaucoma not adequately controlled
Exclusion criteria
* Diagnosis of glaucoma other than open angle glaucoma * Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System. * Neovascular glaucoma in the study eye * Prior glaucoma surgery in the study eye * Clinically significant corneal disease * Patients with poor vision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in medicated diurnal IOP | 6 months after surgery | DODT/SODT arm will be evaluated separately |
Countries
Colombia, India, Panama
Outcome results
None listed