The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP): The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanoculis Ltd
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female ≥ 18 years to ≤ 85 years old
Subject who underwent either standalone MIMS® surgery or MIMS® surgery in combination with phacoemulsification, in continuation of the previous clinical investigation with the MIMS® device (see: STUDY ID: MMS EEU-1), and surgery was performed not earlier than 2 years from enrollment
Subject who is considered complete success (i.e., 20% or greater reduction in IOP from Baseline on no medications) and qualified success (i.e., 20% or greater reduction in IOP from Baseline on the same or less number of medications) or failure with IOP \>21mmHg with no medications at 1 year post MIMS® surgery (see: STUDY ID: MMS EEU-1)
Subject who is able and willing to attend all scheduled assessments
Subject understands and signs the informed consent
You may not be if
Subject who was considered failure at 1 year after the MIMS® surgery
Any subject with major protocol deviation from the prior MIMS® study (ID: MMS EEU-1)
Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye, since the MIMS® surgery in the study eye
Any ocular disease in the study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements
Any ocular surgery since the MIMS® surgery in the study eye
Severe trauma in the study eye since the MIMS® surgery in the study eye
Current participation or participation in another investigational drug or device clinical trial within the last 30 days before enrollment in the study
Pregnant or lactating women
Clareo Health | The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP): The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP)
