First in-human clinical performance of a new non-cavitating handheld lensectomy system in 665 consecutive cataract
Tsontcho Ianchulev1, Elizabeth Yeu, Edward H Hu
1From the Ophthalmology, New York Eye and Ear Infirmary of Mount Sinai, New York, New York (Ianchulev, Kamthan, Li); Refractive Surgery, Virginia Eye Consultants, Norfolk, Virginia (Yeu); Wolfe Eye Clinic, Marshalltown, Iowa (Hu); The Eye Centers of Racine and Kenosha, Racine, Wisconsin (Singh); Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania (Pantanelli); The Cape Coral Eye Center, Cape Coral, Florida (Tyson).
Purpose:
To investigate the intraoperative performance and lens fragmentation efficacy of a non-cavitating handheld lensectomy system in mild, moderate, and severe cataract.
Setting:
Ambulatory surgical centers.
Design:
Retrospective consecutive case series.
Methods:
665 consecutive eyes underwent cataract surgery by 12 surgeons using a new handheld non-cavitating lensectomy system for nuclear fragmentations and extraction. Intraoperative measurements included surgical time, miLOOP pretreatment, and irrigation fluid use.
Results:
Of the 665 eyes, 38 (6%), 468 (70%), 126 (19%), and 33 (5%) were of grade 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 seconds, 100.3 seconds, 132.6 seconds, and 287.9 seconds for grades 1, 2, 3, and 4, respectively ( P < .001). In addition, irrigation and aspiration cortical removal times were 64.1 seconds, 51.1 seconds, 48.5 seconds, and 59.0 seconds, respectively ( P = .14). There was a low rate of capsular tear (3 cases in 665 surgeries, 0.45%) and no other emergent adverse events.
Conclusions:
The miCOR handheld non-cavitating lensectomy system demonstrated nuclear fragmentation and extraction in the absence of intraocular cavitation across all grades of nuclear densities.
