Intermediate term results suggest that ab-interno Minimally Invasive Micro Sclerostomy (MIMS) stent less subconjunctival filtration procedure is a promising treatment option for patients with open angle glaucoma.
Minimally Invasive Micro Sclerostomy (MIMS) is a novel ab-interno, stent-less, subconjunctival filtration procedure. This study set to investigate the safety, performance and efficacy of MIMS in open angle glaucoma patients.
Prospective, open-label, single arm clinical trial with intra-subject comparisons. Study participants were adults with open angle glaucoma who were candidates for a filtration procedure. Patients were operated by a single surgeon (A.A) in Chennai, India. Following mitomycin C pretreatment, Ab-interno MIMS procedure was performed alone or combined with Phacoemulsification surgery. Procedure-related complications and adverse events were assessed. Primary outcomes: patients (%) achieving an IOP≥5▒mmHg and ≤18▒mmHg, and an IOP reduction of >20% as compared to baseline, with or without hypotensive medications, with no need for recurrent surgery.
21 Phacoemulsification-MIMS and 10 standalone MIMS procedures were performed. Mean age was 63.94±6.33 years. Mean duration of MIMS was 1:58±0:25 (min:sec). Scleral tunnels were achieved in all cases. No device malfunctions, intra-operative complications, or serious adverse events were reported. Five (16.12%) patients presented with iris clogging 1-24 weeks following procedure. Two were treated with laser and 3 required trabeculectomy. Mean IOP change from baseline at 24 weeks was 47.4% (31.2 to 16.4▒mmHg, P<0.0001, n=23). The mean difference was −14.8▒mmHg (95% CI: −17.6, −11.9) with no statistically significant differences between groups. Qualified success was achieved in 21 (84%), 17 (74%) and 13 (93%) after 12, 24, and 52 weeks, respectively. Complete success was achieved in 17 (68%), 13 (57%) and 8 (57%) after 12, 24, and 52 weeks, respectively.
The interim results suggest that MIMS procedure may be a simple and effective surgical option for early open angle glaucoma patients requiring target IOP in high teens although iris clogging of incision site is the major concern with this procedure.