J Glaucoma. 2021 Nov 3. doi: 10.1097/IJG.0000000000001955. Online ahead of print.
ABSTRACT
PRECIS: 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.
PURPOSE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
PMID:34731867 | DOI:10.1097/IJG.0000000000001955
