A Single-Centre Case Series Evaluating The Safety And Efficacy Of Minimally Invasive Micro Sclerostomy In Patients With Glaucoma And Ocular Hypertension In Germany

Minimally invasive micro sclerostomy (MIMS®) is an ab interno, implant-free, bleb forming, procedure. It is designed to reduce intraocular pressure (IOP) by creating a ~100 μm drainage channel at the sclera-corneal junction extending from the anterior chamber to the subconjunctival space. The MIMS® device has received the CE Mark in Europe, with studies to date demonstrating IOP-lowering efficacy with minimal complications. This single-centre case series aimed to evaluate the safety and efficacy outcomes in patients with glaucoma and ocular hypertension treated with MIMS.

The MIMS procedures were performed by one surgeon at Viselle Augenzentrum Erlangen in patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PEXG), normal tension glaucoma (NTG), ocular hypertension (OHT) and secondary open-angle glaucoma (SOAG). The procedures were conducted between June 2023 and January 2024; follow-up is going with data available up to 24 months.  

Key outcome measures included reduction in IOP from baseline, change in no. of glaucoma medications from baseline, proportion of patients requiring secondary interventions, proportion of patients achieving IOP <18 mmHg and <15 mmHg, and incidence of adverse events. Patients were assessed at baseline and at post-operative follow‑up visits on Day 1, Weeks 1, and 2, and Months 1, 3, 6, 12, 18, and 24.

Thirty eyes of 30 patients were treated. Mean ± SD baseline IOP was 26.5 ± 9.3 mmHg and 30/30 eyes required glaucoma medication (mean no. of medications: 2.7). During a mean ± SD follow-up period of 8.2 ± 7.8 months, mean ± SD post-operative IOP was 19.1 ± 8.2 mmHg and mean no. of medications was 0.3 ± 0.8. Following MIMS®, 70% (21/30) of patients did not require secondary intervention. In these patients, mean ± SD baseline IOP was 25.5 ± 9.5 mmHg. During follow-up of these patients, 18/21 (86%) did not require glaucoma medication, 19/21 (90%) achieved an IOP<18 mmHg and 14/21 (67%) achieved an IOP <15 mmHg. By Month 24, there was one case (1/30) of numerical hypotony.

In this patient population, MIMS effectively reduced IOP and medication requirement during follow-up with minimal intra- and post-operative complications. This case series suggests that MIMS may be an effective treatment option for patients with OHT and glaucoma, including POAG, PEXG, NTG and SOAG, but longer-term data with a larger patient sample would be needed to support the efficacy and safety of MIMS in these patient populations.