A Prospective Single-Center Clinical Trial Comparing Short-Term Outcomes of a Novel Non-Cavitating Handheld Lensectomy Device versus Phacoemulsification.

PURPOSE: To compare the short-term outcomes of a non-cavitating lensectomy device (MICOR) to phacoemulsification.

PATIENTS AND

METHODS

This was a two-arm prospective open-label clinical trial. Patients with visually significant cataracts at a single academic center between March and December 2023 were consecutively enrolled to undergo cataract surgery using either MICOR or phacoemulsification for nuclear fragmentation and lens removal. Adverse events (AE), lensectomy time, fluid use, and ultrasound energy use were assessed intraoperatively. Visual acuity, refraction, and AE were assessed on postoperative day one.

RESULTS

A total of 34 eyes of 23 patients were included in the MICOR arm and 50 eyes of 32 patients in the phacoemulsification arm. No difference (p = 0.727) in logMAR best corrected distance visual acuity was observed postoperatively between MICOR (0.14 ± 0.25) and phacoemulsification (0.16 ± 0.33), nor was any difference observed in AE rates [3% versus 8%, respectively (p = 0.644)]. Lens removal time was faster with MICOR [209 vs 255 s (p = 0.003)], including for grade 2 cataracts [203 vs 237 s (p = 0.008)]. Irrigation volume was less for MICOR [33 vs 62 mL (p < 0.001)], including for grade 2 [34 vs 60 mL (p < 0.001)] and 3 cataracts [36 vs 60 mL (p = 0.004)]. Mean cumulative dissipated energy for phacoemulsification was 8.7.

CONCLUSION

Compared to phacoemulsification, MICOR has similar visual outcomes and adverse event rates while requiring less time, irrigation fluid, and ultrasound energy, suggesting MICOR is a viable alternative to phacoemulsification.