Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study

Tsontcho Ianchulev, David F Chang, Edward Koo, Susan MacDonald, Ernesto Calvo, Farrell Toby Tyson, Andrea Vasquez, Iqbal Ike K Ahmed, Tsontcho Ianchulev, David F Chang, Edward Koo, Susan MacDonald, Ernesto Calvo, Farrell Toby Tyson, Andrea Vasquez, Iqbal Ike K Ahmed

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.

Keywords: Clinical Trial; Lens and zonules; Optics and Refraction; Pathology; Treatment Surgery.

Conflict of interest statement

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.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The miLOOP device (A) is a handheld single-use unit with a sliding actuator button that controls expansion and constriction (B) of a cutting loop constructed of a single 300 µm diameter nitinol microfilament.
Figure 2
Figure 2
miLOOP expansion in the coronal hydrodissection plane prior to nuclear encirclement, endocapsular rotation and first nuclear bisection.
Figure 3
Figure 3
Miyake-Apple view of the microinterventional loop in a sagittal endocapsular position prior to initiating a full-thickness nuclear cut (A) and midway through the bisection (B). Panel (C) shows the dissection plane of the cleanly bisected nucleus (human cadaver study).

References

    1. DeBry P, Olson RJ, Crandall AS. Comparison of energy required for phaco-chop and divide and conquer phacoemulsification. J Cataract Refract Surg 1998;24:689–92. 10.1016/S0886-3350(98)80267-8
    1. Ram J, Wesendahl TA, Auffarth GU, et al. . Evaluation of in situ fracture versus phaco chop techniques. J Cataract Refract Surg 1998;24:1464–8. 10.1016/S0886-3350(98)80167-3
    1. Wong T, Hingorani M, Lee V. Phacoemulsification time and power requirements in phaco chop and divide and conquer nucleofractis techniques. J Cataract Refract Surg 2000;26:1374–8. 10.1016/S0886-3350(00)00538-1
    1. Pirazzoli G, D'Eliseo D, Ziosi M, et al. . Effects of phacoemulsification time on the corneal endothelium using phacofracture and phaco chop techniques. J Cataract Refract Surg 1996;22:967–9. 10.1016/S0886-3350(96)80200-8
    1. Park J, Yum HR, Kim MS, et al. . Comparison of phaco-chop, divide-and-conquer, and stop-and-chop phaco techniques in microincision coaxial cataract surgery. J Cataract Refract Surg 2013;39:1463–9. 10.1016/j.jcrs.2013.04.033
    1. Demong TT, Chacon-Andrade HE, Demong PM. Modified Akahoshi phaco prechop plus phaco chop technique: a prospective study of 418 eyes. Clinical and Surg Ophthalmol 2005;23:246–50.
    1. Hatch KM, Schultz T, Talamo JH, et al. . Femtosecond laser-assisted compared with standard cataract surgery for removal of advanced cataracts. J Cataract Refract Surg 2015;41:1833–8. 10.1016/j.jcrs.2015.10.040
    1. Chen X, Yu Y, Song X, et al. . Clinical outcomes of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery for hard nuclear cataracts. J Cataract Refract Surg 2017;43:486–91. 10.1016/j.jcrs.2017.01.010
    1. Chang DF. Does femtosecond laser-assisted cataract surgery improve corneal endothelial safety? The debate and conundrum. J Cataract Refract Surg 2017;43:440–2. 10.1016/j.jcrs.2017.04.019
    1. Kamoi K, Mochizuki M. Phaco forward-chop technique for managing posterior nuclear plate of hard cataract. J Cataract Refract Surg 2010;36:9–12. 10.1016/j.jcrs.2009.07.047
    1. Singh R, Vasavada AR, Janaswamy G. Phacoemulsification of brunescent and black cataracts. J Cataract Refract Surg 2001;27:1762–9. 10.1016/S0886-3350(01)00839-2
    1. Mahdy MA, Eid MZ, Mohammed MA, et al. . Relationship between endothelial cell loss and microcoaxial phacoemulsification parameters in noncomplicated cataract surgery. Clin Ophthalmol 2012;6:503–10. 10.2147/OPTH.S29865
    1. Manning S, Barry P, Henry Y, et al. . Femtosecond laser-assisted cataract surgery versus standard phacoemulsification cataract surgery: study from the European Registry of Quality Outcomes for Cataract and Refractive Surgery. J Cataract Refract Surg 2016;42:1779–90. 10.1016/j.jcrs.2016.10.013
    1. Vasavada AR, Raj SM, Patel U, et al. . Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial. Ophthalmic Surg Lasers Imaging 2010;41:109–14. 10.3928/15428877-20091230-20
    1. Jaycock P, Johnston RL, Taylor H, et al. . The Cataract National Dataset electronic multi-centre audit of 55,567 operations: updating benchmark standards of care in the United Kingdom and internationally. Eye 2009;23:38–49. 10.1038/sj.eye.6703015
    1. Yi DH, Sullivan BR. Phacoemulsification with indocyanine green versus manual expression extracapsular cataract extraction for advanced cataract. J Cataract Refract Surg 2002;28:2165–9.
    1. Ermisş SS, Oztürk F, Inan UU. Comparing the efficacy and safety of phacoemulsification in white mature and other types of senile cataracts. Br J Ophthalmol 2003;87:1356–9. 10.1136/bjo.87.11.1356
    1. Bayramlar H, Hepsen IF, Yilmaz H. Mature cataracts increase risk of capsular complications in manual small-incision cataract surgery of pseudoexfoliative eyes. Can J Ophthalmol 2007;42:46–50. 10.3129/can.j.ophthalmol.06-085
    1. Venkatesh R, Tan CS, Sengupta S, et al. . Phacoemulsification versus manual small-incision cataract surgery for white cataract. J Cataract Refract Surg 2010;36:1849–54. 10.1016/j.jcrs.2010.05.025
    1. Cook C, Carrara H, Myer L. Phaco-emulsification versus manual small-incision cataract surgery in South Africa. S Afr Med J 2012;102:537–40. 10.7196/SAMJ.5393

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する