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A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inferonasal MIMS Surgery Cohort | Cohort that includes subjects that have undergone the MIMS® inferonasal surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inferonasal Minimally Invasive Micro Sclerostomy | Device | The Inferonasal MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the inferonasal quadrant of the eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure Change (Baseline to 24 months) | Change in IOP from medicated baseline to 24 months post-MIMS® surgery | Baseline to 24 months post-MIMS® surgery |
| Intraocular Pressure Change (Baseline to 30 months) | Change in IOP from medicated baseline to 30 months post-MIMS® surgery | Baseline to 30 months post-MIMS® surgery |
| Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months) | Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery | Medicated baseline to 24 months post-MIMS® surgery |
| Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months) | Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery | Medicated baseline to 30 months post-MIMS® surgery |
| Surgery Success Rate (24 months) | Success rate 24 months post-MIMS® surgery | 24 months post-MIMS® surgery |
| Surgery Success Rate (30 months) | Success rate 30 months post-MIMS® surgery | 30 months post-MIMS® surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complication Safety Outcomes | Late (greater than 12 months) postoperative complications | Baseline to 30 months post-MIMS® surgery |
| Interventional Safety Outcomes | Late (greater than 12 months) postoperative interventions |
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Inclusion Criteria:
1. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment
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The study population consists of subjects of Armenian descent that underwent the MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khan Lau, OD | Contact | 8082862666 | khan@sanoculis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. Malayan Eye Center | Recruiting | Yerevan | Armenia |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Baseline to 30 months post-MIMS® surgery |