Glaucoma
Conditions
Brief summary
No new investigational device is used in this study. This study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System \[MIMS® System\] \[CE Marked device\] are evaluated.
Interventions
DIAGNOSTIC_TESTMIMS
This study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System \[MIMS® System\] \[CE Marked device\] are evaluated.
Sponsors
Sanoculis Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed IOP at Long- Term ( >2 Years) post-MIMS® surgery: | 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery | • IOP will be measured for subjects who have completed the MIMS® surgery and no earlier than 2 years from the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • IOP Levels at the following time points: | 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery | IOP will be measured for subjects who have completed the MIMS® surgery and assessed at least one of the following visits (the data from more than one visit will be also collected): 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery |
Countries
Armenia
Outcome results
None listed