Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2019 Feb;103(2):176-180.
doi: 10.1136/bjophthalmol-2017-311766. Epub 2018 Apr 18.

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

Tsontcho Ianchulev  1 , David F Chang  2 , Edward Koo  2 , Susan MacDonald  3 , Ernesto Calvo  4 , Farrell Toby Tyson  5 , Andrea Vasquez  4 , Iqbal Ike K Ahmed  6   7
Affiliations
Randomized Controlled Trial

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

Tsontcho Ianchulev et al. Br J Ophthalmol. 2019 Feb.

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.

PubMed Disclaimer

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.

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).
See this image and copyright information in PMC

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 - DOI - PubMed
    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 - DOI - PubMed
    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 - DOI - PubMed
    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 - DOI - PubMed
    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 - DOI - PubMed

Publication types

Associated data