TY - JOUR
T1 - First in-human clinical performance of a new non-cavitating handheld lensectomy system in 665 consecutive cataract surgeries
AU - Ianchulev, Tsontcho
AU - Yeu, Elizabeth
AU - Hu, Edward H.
AU - Singh, Paul
AU - Kamthan, Gautam
AU - Li, Gavin
AU - Pantanelli, Seth
AU - Tyson, Farrell
N1 - Publisher Copyright:
© 2024 Lippincott Williams and Wilkins. All rights reserved.
PY - 2024/7/1
Y1 - 2024/7/1
N2 - 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.
AB - 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.
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U2 - 10.1097/j.jcrs.0000000000001446
DO - 10.1097/j.jcrs.0000000000001446
M3 - Article
C2 - 38517982
AN - SCOPUS:85197915434
SN - 0886-3350
VL - 50
SP - 693
EP - 697
JO - Journal of Cataract and Refractive Surgery
JF - Journal of Cataract and Refractive Surgery
IS - 7
ER -