Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No new investigational device is used in this study. This study is an extension follow up study conducted in continuation of the prior MIMSĀ® 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 [MIMSĀ® System] [CE Marked device] are evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm: MIMSĀ® Minimally Invasive Trabeculostomy in OAG Patients (36-Month Follow-Up) | Experimental | This follow-up extension study is aimed to monitor the long-term IOP-lowering performance/efficacy and safety of the MIMSĀ® procedure in open angle glaucoma eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIMS | Diagnostic Test | This study is an extension follow up study conducted in continuation of the prior MIMSĀ® 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 [MIMSĀ® System] [CE Marked device] are evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| Observed IOP at Long- Term ( >2 Years) post-MIMS® surgery: | ⢠IOP will be measured for subjects who have completed the MIMS® surgery and no earlier than 2 years from the procedure. | 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery |
| Measure | Description | Time Frame |
|---|---|---|
| ⢠IOP Levels at the following time points: | 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 | 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malayan | Yerevan | Armenia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided