PMID- 35942081
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231105
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 16
DP  - 2022
TI  - Comparative Study of Safety Outcomes Following Nucleus Disassembly with and 
      without the miLOOP Lens Fragmentation Device During Cataract Surgery.
PG  - 2391-2401
LID - 10.2147/OPTH.S370290 [doi]
AB  - PURPOSE: To determine the effect of a microinterventional lens prefragmentation 
      wire loop device (miLOOP((R)); Carl Zeiss Meditec AG, Oberkochen, Germany), on 
      adverse events (AEs), cumulative dispersed energy (CDE), and vision outcomes when 
      used before phacoemulsification of high-grade mature cataracts. SETTING: Three 
      ambulatory surgical centers in the Peoria, IL region. DESIGN: Retrospective 
      comparative consecutive case series; single-surgeon. METHODS: Patient outcomes 
      were compared before and after introduction of miLOOP-assisted lens fragmentation 
      prior to phacoemulsification during cataract surgeries performed 2016‒2020. The 
      primary outcome was intraoperative AE rate/type. Secondary outcomes included 
      ultrasound cumulative dispersed energy (CDE) administered during 
      phacoemulsification, postoperative AEs, and best-corrected visual acuity (BCVA). 
      RESULTS: Data from 765 subjects (mean age 72.9 years; 1025 eyes) comprised 524 
      conventional lens disassembly (Control) eyes and 501 Device eyes. One hundred 
      percent of the cataracts in both groups were advanced WHO Grade 3+ nuclei. 
      Significantly fewer intraoperative AEs occurred in the Device group versus 
      Controls (2.2% and 6.3% of eyes, respectively; p=0.0011). Postoperative AE rates 
      were comparable between groups (Controls=2.9%, Device=3.5%). Mean CDE from 
      ultrasound was significantly reduced by 21% when the microfilament loop device 
      was used for nuclear disassembly (9.6+/-5.2 CDE units) versus Controls (11.6+/-6.4 
      CDE units; p<0.0001). Median postoperative BCVA was 20/25 Snellen (0.091 logMAR) 
      in both groups. More than 70% of both Control and Device eyes had postoperative 
      BCVA better than 20/30 Snellen. CONCLUSION: Microinterventional lens 
      fragmentation was associated with lower ultrasound energy use and improved 
      intraoperative safety than traditional unassisted surgery of advanced high-grade 
      cataracts, while maintaining similarly acceptable postoperative complication 
      rates and BCVA functional outcomes.
CI  - (c) 2022 Hu et al.
FAU - Hu, Edward H
AU  - Hu EH
AD  - Wolfe Eye Clinic, Marshalltown, IA, USA.
FAU - Buie, Therese
AU  - Buie T
AD  - Illinois Eye Center, Peoria, IL, USA.
FAU - Jensen, Rishma J
AU  - Jensen RJ
AD  - Illinois Eye Center, Peoria, IL, USA.
FAU - Wu, David
AU  - Wu D
AUID- ORCID: 0000-0002-1763-9674
AD  - University of Illinois at Chicago, Chicago, IL, USA.
FAU - Pamnani, Ravinder D
AU  - Pamnani RD
AD  - Byers Center for Biodesign, Stanford University, Stanford, CA, USA.
LA  - eng
PT  - Journal Article
DEP - 20220802
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC9356701
OTO - NOTNLM
OT  - adverse events
OT  - cumulative dispersed energy
OT  - lens disassembly
OT  - microinterventional surgery
OT  - phacoemulsification cataract surgery
OT  - safety
COIS- EHH reports grants from Zeiss, during the conduct of the study, and has received 
      consulting fees from Carl Zeiss Meditec Cataract Technology, Inc. RDP reports 
      personal fees from Carl Zeiss Meditec AG, during the conduct of the study; 
      personal fees from Iantrek, Inc., outside the submitted work; and has received 
      consulting fees from Carl Zeiss Meditec Cataract Technology, Inc. The authors 
      report no other potential conflicts of interest in relation to this work, 
      financial or otherwise.
EDAT- 2022/08/10 06:00
MHDA- 2022/08/10 06:01
PMCR- 2022/08/02
CRDT- 2022/08/09 02:01
PHST- 2022/04/11 00:00 [received]
PHST- 2022/07/15 00:00 [accepted]
PHST- 2022/08/09 02:01 [entrez]
PHST- 2022/08/10 06:00 [pubmed]
PHST- 2022/08/10 06:01 [medline]
PHST- 2022/08/02 00:00 [pmc-release]
AID - 370290 [pii]
AID - 10.2147/OPTH.S370290 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2022 Aug 2;16:2391-2401. doi: 10.2147/OPTH.S370290. eCollection 
      2022.