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Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study
  1. Tsontcho Ianchulev1,
  2. David F Chang2,
  3. Edward Koo2,
  4. Susan MacDonald3,
  5. Ernesto Calvo4,
  6. Farrell Toby Tyson5,
  7. Andrea Vasquez4,
  8. Iqbal Ike K Ahmed6,7
  1. 1 New York Eye and Ear Infirmary, Icahn School of Medicine at Mount Sinai, New York, NY 1183, USA
  2. 2 Department of Ophthalmology, UCSF School of Medicine, San Francisco, California, USA
  3. 3 Department of Ophthalmology, Tufts School of Medicine, Boston, Massachusetts, USA
  4. 4 Clínica de Ojos Orillac-Calvo, Panama City, Panama
  5. 5 Cape Coral Eye Center, Cape Coral, Florida, USA
  6. 6 Department of Ophthalmology, University of Toronto, Toronto, Ontario, Canada
  7. 7 Trillium Health Partners and Credit Valley Eye Care, Mississauga, Ontario, Canada
  1. Correspondence to Dr Tsontcho Ianchulev, New York Eye and Ear Infirmary, Icahn School of Medicine, New York 1183, USA; tianchul{at}yahoo.com

Abstract

Aim To assess the safety and efficacy of microinterventional endocapsular nuclear fragmentation in moderate to severe cataracts.

Methods This was a prospective single-masked multisurgeon interventional randomised controlled trial (ClinicalTrials.gov NCT02843594) where 101 eyes of 101 subjects with grade 3‒4+ nuclear cataracts were randomised to torsional phacoemulsification alone (controls) or torsional phacoemulsification with adjunctive endocapsular nuclear fragmentation using a manual microinterventional nitinol filament loop device (miLOOP group). Outcome measures were phacoemulsification efficiency as measured by ultrasound energy (cumulative dispersed energy (CDE) units) and fluidics requirements (total irrigation fluid used) as well as incidence of intraoperative and postoperative complications.

Results Only high-grade advanced cataracts were enrolled with more than 85% of eyes with baseline best corrected visual acuity (BCVA) of 20/200 or worse in either group. Mean CDE was 53% higher in controls (32.8±24.9 vs 21.4±13.1 with miLOOP assistance) (p=0.004). Endothelial cell loss after surgery was low and similar between groups (7‒8%, p=0.561) One-month BCVA averaged 20/27 Snellen in miLOOP eyes and 20/24 in controls. No direct complications were caused by the miLOOP. In two cases, capsular tears occurred during IOL implantation and in all remaining cases during phacoemulsification, with none occurring during the miLOOP nucleus disassembly part of the procedure.

Conclusions Microinterventional endocapsular fragmentation with the manual, disposable miLOOP device achieved consistent, ultrasound-free, full-thickness nucleus disassembly and significantly improved overall phaco efficiency in advanced cataracts.

Trial registration number NCT02843594

  • Treatment Surgery
  • Optics and Refraction
  • Lens and zonules
  • Pathology
  • Clinical Trial

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0

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Footnotes

  • Contributors Conception and design of the study (TI, EC); data collection (TI, EC); analysis and interpretation (TI, DFC, EK, SM, EC, FTT, AV, IIKA); writing of the article (TI, DFC, EK, SM, EC, FTT, AV, IIKA); critical revision of the article (TI, DFC, EK, SM, EC, FTT, AV, IIKA); final approval of the article (TI, DFC, EK, SM, EC, FTT, AV, IIKA); obtained funding (TI); literature search (TI, EC); administrative, technical or logistic support (AV).

  • Funding This study was funded by IanTech, the device manufacturer.

  • Competing interests TI is the CEO of IanTech. DFC is a consultant for IanTech and has an ownership interest in the company. EK, EC and FTT have financial interests in IanTech. SM is a consultant for IanTech and Perfect Lens. AV received study funding from IanTech. IIKA has a consultancy (C), or received speaker fees (S) or research funding (R) from: Abbott Medical Optics (AMO), C,S,R; Acucela, C; Aerie Pharmaceuticals, C,R; Alcon, C,S,R; Allergan, C,S,R; ArcScan, C; Bausch and Lomb, C; Carl Zeiss Meditec, C,S,R; Centervue, C; Clarity Medical Systems, C; ElutiMed, C; Envisia Therapeutics, C; Equinox, C; Eyelight, C; ForSight Labs, C; Glaukos, C,R; Gore, C; IanTech, C; InjectSense, C; InnFocus, C; Iridex, C; iStar, C; Ivantis, C,R; KeLoTec, C; LayerBio, C; Leica Microsystems, C; New World Medical, C,R; Omega Ophthalmics, C; Ono Pharma, C; PolyActiva, C; Sanoculis, C; Santen, C; Science Based Health, C; SOLX, C; Stroma, C; TrueVision, C.

  • Patient consent Obtained.

  • Ethics Approval The study protocol was approved by the Institutional Review Board of the Clínica de Ojos Orillac-Calvo, Panama City, Panama.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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