The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Creation of a drainage channel of 50 - 100 microns (diameter) at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjuctival space).
Goldschleger Eye Institute, The Chaim Sheba Medical Center
Tel Litwinsky, Israel
Overall incidence of serious adverse events
Time frame: 12 weeks
Incidence of serious adverse events
Time frame: 24 weeks
intraocular pressure (IOP) between 6 mmHg and 15 mmHg without medication
Time frame: 24 weeks
Change in number of glaucoma medications from baseline in the study eye
Time frame: 24 weeks
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