The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy.
Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C.
Male or female, ≥ 40 years to ≤ 85 years old
Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy
Visual field mean deviation of -3dB or worse and
Glaucomatous optic nerve damage as evidenced by optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos
None
Single group
Minimally Invasive Micro Sclerostomy Device
DeviceDuring this clinical trial, the Minimally Invasive Micro Sclerostomy (MIMS®) procedure will be performed by investigators using the proprietary MIMS® device developed by Sanoculis Ltd.
Surgical success rate of the MIMS® device/procedure at 12 months after surgery
Definition of Surgical Success: the subject's eye, after having the MIMS® procedure: 1. Achieved 20% or more reduction in average diurnal IOP from baseline at 12 months after surgery; AND 2. Using the same number or fewer topical IOP lowering medications
Exploratory Effectiveness Endpoint 1
Change in IOP (mmHg) from baseline to 12 months follow-up
Exploratory Effectiveness Endpoint 2
Change in IOP (% change) from baseline to 12 months follow-up
Exploratory Effectiveness Endpoint 3
Change in the number of IOP lowering topical medications from screening to 12 months follow-up
Exploratory Effectiveness Endpoint 4
Change in number (% change) of IOP lowering topical medications from screening to 12 months follow-up
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