PMID- 38517982 OWN - NLM STAT- Publisher LR - 20240322 IS - 1873-4502 (Electronic) IS - 0886-3350 (Linking) DP - 2024 Mar 22 TI - First in-human clinical performance of a novel non-cavitating hand-held lensectomy system in 665 consecutive cataract surgeries. LID - 10.1097/j.jcrs.0000000000001446 [doi] 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 novel handheld non-cavitating lensectomy system for nuclear fragmentations and extraction. Intraoperative measurements included surgical time, miLOOP pre-treatment, and irrigation fluid use. RESULTS: 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). CONCLUSION: The miCOR handheld non-cavitating lensectomy system demonstrated nuclear fragmentation and extraction in the absence of intraocular cavitation across all grades of nuclear densities. CI - Copyright (c) 2024 Published by Wolters Kluwer on behalf of ASCRS and ESCRS. FAU - Ianchulev, Sean AU - Ianchulev S AD - Ophthalmology, New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA. FAU - Yeu, Elizabeth AU - Yeu E AUID- ORCID: 0000-0002-3453-3062 AD - Refractive Surgery, Virginia Eye Consultants, Norfolk, Virginia, USA. FAU - Hu, Edward H AU - Hu EH AD - Wolfe Eye Clinic, Marshalltown, IA, USA. FAU - Singh, Paul AU - Singh P AD - The Eye Centers of Racine and Kenosha, Racine, Wisconsin. FAU - Kamthan, Gautam AU - Kamthan G AUID- ORCID: 0000-0002-7904-3307 AD - Ophthalmology, New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA. FAU - Li, Gavin AU - Li G AUID- ORCID: 0000-0002-4318-7966 AD - Ophthalmology, New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA. FAU - Pantanelli, Seth AU - Pantanelli S AUID- ORCID: 0000-0003-4992-9606 AD - Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania, USA. FAU - Tyson, Farrell AU - Tyson F AD - The Cape Coral Eye Center (Tyson), Cape Coral, Florida, USA. LA - eng PT - Journal Article DEP - 20240322 PL - United States TA - J Cataract Refract Surg JT - Journal of cataract and refractive surgery JID - 8604171 SB - IM EDAT- 2024/03/22 18:44 MHDA- 2024/03/22 18:44 CRDT- 2024/03/22 14:13 PHST- 2024/01/24 00:00 [received] PHST- 2024/03/14 00:00 [accepted] PHST- 2024/03/22 18:44 [medline] PHST- 2024/03/22 18:44 [pubmed] PHST- 2024/03/22 14:13 [entrez] AID - 02158034-990000000-00396 [pii] AID - 10.1097/j.jcrs.0000000000001446 [doi] PST - aheadofprint SO - J Cataract Refract Surg. 2024 Mar 22. doi: 10.1097/j.jcrs.0000000000001446.