Comparative Study of Safety Outcomes Following Nucleus Disassembly with and without the miLOOP Lens Fragmentation Device During Cataract Surgery

PURPOSE: To determine the effect of a microinterventional lens prefragmentation wire loop device (miLOOP(®); Carl Zeiss Meditec AG, Oberkochen, Germany), on adverse events (AEs), cumulative dispersed energy (CDE), and vision outcomes when used before phacoemulsification of high-grade mature cataracts. SETTING: Three ambulatory surgical centers in the Peoria, IL region. DESIGN: Retrospective comparative consecutive case series; single-surgeon. METHODS: Patient outcomes were compared before and after introduction of miLOOP-assisted lens fragmentation prior to phacoemulsification during cataract surgeries performed 2016‒2020. The primary outcome was intraoperative AE rate/type. Secondary outcomes included ultrasound cumulative dispersed energy (CDE) administered during phacoemulsification, postoperative AEs, and best-corrected visual acuity (BCVA). RESULTS: Data from 765 subjects (mean age 72.9 years; 1025 eyes) comprised 524 conventional lens disassembly (Control) eyes and 501 Device eyes. One hundred percent of the cataracts in both groups were advanced WHO Grade 3+ nuclei. Significantly fewer intraoperative AEs occurred in the Device group versus Controls (2.2% and 6.3% of eyes, respectively; p=0.0011). Postoperative AE rates were comparable between groups (Controls=2.9%, Device=3.5%). Mean CDE from ultrasound was significantly reduced by 21% when the microfilament loop device was used for nuclear disassembly (9.6±5.2 CDE units) versus Controls (11.6±6.4 CDE units; p<0.0001). Median postoperative BCVA was 20/25 Snellen (0.091 logMAR) in both groups. More than 70% of both Control and Device eyes had postoperative BCVA better than 20/30 Snellen. CONCLUSION: Microinterventional lens fragmentation was associated with lower ultrasound energy use and improved intraoperative safety than traditional unassisted surgery of advanced high-grade cataracts, while maintaining similarly acceptable postoperative complication rates and BCVA functional outcomes.