First in-human clinical performance of a novel non-cavitating hand-held lensectomy system in 665 consecutive cataract surgeries.

Abstract

To investigate the intraoperative performance and lens fragmentation efficacy of a non-cavitating handheld lensectomy system in mild, moderate, and severe cataract. Ambulatory surgical centers. Retrospective consecutive case series. 665 consecutive eyes underwent cataract surgery by 12 surgeons using a novel handheld non-cavitating lensectomy system for nuclear fragmentations and extraction. Intraoperative measurements included surgical time, miLOOP pre-treatment, and irrigation fluid use. Of the 665 eyes, 38 (6%), 468 (70%), 126 (19%) and 33 (5%) were Grades 1, 2, 3 and 4 nuclear densities, respectively, as graded by the surgeon intraoperatively. Successful nuclear fragmentation, lens extraction and cortical removal were achieved in all eyes. Total nucleus fragmentation and extraction times were 70.1, 100.3, 132.6 and 287.9 seconds for grades 1,2,3 and 4 respectively (p < 0.001). Additionally, irrigation and aspiration (I/A) cortical removal times were 64.1, 51.1, 48.5 and 59.0 seconds respectively (p = 0.14). There was a low rate of capsular tear (3 cases in 665 surgeries, 0.45%) and no other emergent adverse events (AEs). The miCOR handheld non-cavitating lensectomy system demonstrated nuclear fragmentation and extraction in the absence of intraocular cavitation across all grades of nuclear densities.