Minimally Invasive Micro Sclerostomy (MIMS©): 42-Month Performance and Safety in Open-Angle Glaucoma
Abstract:
Minimally Invasive Micro Sclerotomy (MIMS) is an ab interno subconjunctival bleb-forming stent-less device de signed to reduce intraocular pressure (IOP) in subjects with open- angle glaucoma (OAG). This 42-month prospec tive follow-up extension study was aimed at reporting the long-term outcomes of MIMS as a standalone procedure or combined with phacoemulsification. edema, attributed to patient’s age and health condition. Thirty MIMS-treated eyes for primary OAG or pseudoexfoliative glaucoma (PXFG) with uncontrolled IOP >21 mmHg on tolerated topical medication at baseline that showed ≥20% IOP reduction at Month 12 follow-up visit in the prior trial and additional 18 eyes considered as failures were included in the overall success and survival anal ysis. The mean (±STD) baseline IOP (27.3±3.2 mmHg) was reduced by 33.0% to 17.8±5.9 mmHg and by 37.4% to 17.0±4.6 mmHg at Month 36 and 42 visits, respectively. Qualified success of ≥20% IOP reduction on the same or fewer hypotensive medications was achieved in 54.2% eyes (47.4% for MIMS stand-alone and 80% for phacoemul sification-MIMS). Complete success of ≥20% IOP reduction with no hypotensive medications was observed in 39.6% of the MIMS-treated eyes (31.6% for MIMS stand-alone and 70.0% for phacoemulsification- MIMS). Between 12 and 42 months, 9.2% eyes were reoperated for glaucoma and 2.5% eyes had 20% endothelial cell loss without corneal These findings demonstrate the long-term (up to 3 years) effectiveness and safety of the MIMS device for OAG and PXFG patients, both as a standalone procedure and in combination with phacoemulsification, positioning it as a viable choice for minimally invasive surgical intervention.
