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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
129
During this clinical trial, the Minimally Invasive Micro Sclerostomy (MIMS®) procedure will be performed by investigators using the proprietary MIMS® device developed by Sanoculis Ltd.
Glaucoma Associates of Texas
Dallas, Texas, United States
RECRUITINGSurgical 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
Time frame: 12 months
Exploratory Effectiveness Endpoint 1
Change in IOP (mmHg) from baseline to 12 months follow-up
Time frame: 12 months
Exploratory Effectiveness Endpoint 2
Change in IOP (% change) from baseline to 12 months follow-up
Time frame: 12 months
Exploratory Effectiveness Endpoint 3
Change in the number of IOP lowering topical medications from screening to 12 months follow-up
Time frame: 12 months
Exploratory Effectiveness Endpoint 4
Change in number (% change) of IOP lowering topical medications from screening to 12 months follow-up
Time frame: 12 months
Safety Outcome 1
Incidence of ocular adverse events in the study eye (overall and related to MIMS® device/procedure) throughout the follow-up period
Time frame: 12 months
Safety Outcome 2
Biomicroscopic slit lamp and ophthalmoscopy findings
Time frame: 12 months
Safety Outcome 3
Preservation of Best-Corrected Visual Acuity (BCVA)
Time frame: 12 months
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