Minimally invasive micro sclerostomy (MIMS) procedure in the treatment of open-angle glaucoma.

BACKGROUND: To evaluate the safety and efficacy of the Minimally Invasive Micro Sclerotomy (MIMS) procedure in the management of uncontrolled open-angle glaucoma. METHODS: A prospective, open-label, single-arm clinical evaluation with intra-subject comparisons performed at the Ophthalmologic Center after S.V. Malayan, Yerevan, Armenia. Included were adults with primary open-angle glaucoma (OAG) (N = 114) or exfoliative glaucoma (N = 6) who were uncontrolled (IOP > 21) on tolerated topical medication. Mild (N = 7), moderate (N = 66) and severe (n = 47) cases were prospectively included without preselection. Following subconjunctival Mitomycin C, an ab-interno MIMS procedure was performed alone (N = 100) or combined with phacoemulsification (N = 20). Patients were followed for 52 weeks. Procedure-related complications and adverse events were recorded. Success criteria were defined as -5 < IOP ≤ 21mmHg OR a reduction in IOP of ≥ 20% from baseline with (qualified success) or without (complete success) hypotensive medications. RESULTS: Mean patient age was 69 ± 10.1 years. The mean duration of the procedure was 2:01 ± 0:41 min:sec. Scleral drainage channels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Iris plugging of the sclerostomy site and early spikes in IOP were the most common adverse events. The only reason for failure was final IOP > 21 mmHg on tolerated medication. At 52 weeks (n = 93), mean IOP decreased by 38% from baseline (P < 0.001), from 27.9 ± 3.7 to 17.5 ± 5.3 mmHg, a difference of 10.5 mmHg (95% CI: -11.7, -9.3). One-year qualified success was documented in 82.1% (95% CI: 72.9%,89.2%) of the patients and complete success, in 70.5% (60.3-79.4%). 60% (95 CI:49.4%,69.9%) of the patients achieved maximum IOP level of 14 mmHg or at least 30% reduction in IOP. CONCLUSIONS: MIMS procedure is a relatively simple, short and safe minimally invasive bleb-forming procedure. Its efficacy, as found in this short-term evaluation, lends it suitable for mild and moderate uncontrolled open-angle glaucoma patients. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04503590 2019-05-29.

Aqueous Angiographic Outflow Improvement after Trabecular Microbypass in Glaucoma Patients.

Purpose: To study changes in aqueous humor outflow (AHO) patterns after trabecular micro-bypass (TMB) in glaucoma patients using intraoperative sequential aqueous angiography. Design: Prospective comparative case series. Subjects: Fifteen subjects (14 with glaucoma and 1 normal). Methods: Sequential aqueous angiography (Spectralis HRA+OCT; Heidelberg Engineering) was performed on fourteen glaucoma patients undergoing routine TMB (iStent Inject; Glaukos Corporation) and cataract surgery and one normal patient undergoing cataract surgery alone. Indocyanine green (ICG) aqueous angiography established initial baseline nasal angiographic AHO patterns. Two TMB stents were placed in regions of baseline low or high angiographic AHO in each eye (n = 2 eyes with enough space to place two stents in both low angiographic regions; n = 8 eyes with two stents both placed in high angiographic regions; n = 4 eyes with enough space to place one stent in a low angiographic region and the other stent in a high angiographic region). Subsequent fluorescein aqueous angiography was utilized to query alterations to angiographic AHO patterns. Main Outcome Measure: Angiographic signal and patterns before and after TMB. Results: At baseline, all eyes showed segmental angiographic AHO patterns. Focused on the nasal hemisphere of each eye, for each stent TMB in initially low ICG angiographic signal regions showed transient or persistently improved fluorescein angiographic signal (11.2-fold; p = 0.014). TMB in initially high ICG signal regions led to faster development of fluorescein angiographic patterns (3.1-fold; p = 0.02). Conclusion: TMB resulted in different patterns of aqueous angiographic AHO improvement whose further understanding may advance basic knowledge of AHO and possibly enhance intraocular pressure reduction after glaucoma surgery in the future.