July 2018

CATARACT

Research highlight
First-in-human randomized controlled study compares phaco with miLOOP and phaco alone


by Liz Hillman EyeWorld Senior Staff Writer


Researchers evaluated the efficacy of miLOOP in dense, mature cataract cases compared to traditional phacoemulsification.
Source: Sean Ianchulev, MD

Microinterventional nucleus disassembly with miLOOP resulted in significantly less phaco energy in moderate to advanced cataract

It has been a year since miLOOP (Iantech, Reno, Nevada), an instrument with a superelastic, nitinol microfilament that wraps around a cataract for centripetal endocapsular nuclear disassembly, was introduced.
Susan MacDonald, MD, associate professor, Tufts University School of Medicine, Boston, said she uses it as her “go-to instrument” for difficult cases, including small pupils, zonular instability, hard cataracts, and even soft premium lens cataracts.
“It has improved my surgical time and my technique. This device makes a cases easier, and I use less phaco energy, which ultimately results in a better outcome for the patient,” Dr. MacDonald said.
Dr. MacDonald was one of the investigators on the first-in-human randomized, prospective clinical trial to compare phacoemulsification alone vs. phaco and prefragmentation of dense cataracts with miLOOP, published in the British Journal of Ophthalmology.1
One hundred and one eyes with grade 3–4+ nuclear cataracts were randomized to either undergo torsional phacoemulsification or prefragmentation with miLOOP followed by torsional phacoemulsification. The mean cumulative dispersed energy was 53% higher in the phaco alone group, while endothelial cell loss was similar between the two groups, Ianchulev et al. wrote.
“We’re showing that in the hands of great surgeons, very experienced choppers, and with the top-of-the-line, latest equipment with torsional ultrasound, you can dramatically reduce heat and energy delivered to the eye by using the
miLOOP,” said Sean Ianchulev, MD, professor of ophthalmology, New York Eye and Ear Infirmary, Icahn School of Medicine, New York, and co-founder of the miLOOP technology and Iantech. “Unlike femto and lasers that do prepare the lens … [miLOOP] is a simple, hand-held instrument that uses no energy to prepare the lens to segment it and make phaco easier.”
Though time of the surgical cases was not recorded as an outcome measure, Dr. Ianchulev said the use of miLOOP did not lengthen the procedure. Dr. MacDonald, who said she uses miLOOP for complicated cases outside of this study, said it makes the procedure more efficient, safer, and ultimately faster.
In addition to this paper, Dr. Ianchulev noted that Iantech introduced biLOOP, a two-filament multiloop for nuclear fragmentation, at the 2018 ASCRS•ASOA Annual Meeting. There were almost a dozen peer-reviewed paper presentations at the ASCRS•ASOA Annual Meeting on miLOOP; two were awarded Best Paper of Session awards. These included one that looked at nuclear disassembly with miLOOP in 4–4+ cataracts and another that discussed outcomes of “minicap,” manual small incision cataract surgery (MSICS) with a 5.0 mm incision made possible due to nuclear disassembly with miLOOP.
As executive director of Eye Corps, a nonprofit organization, Dr. MacDonald said she is teaching and using the instrument while working in Tanzania, where almost all of the cataracts she’s seeing are grades 3 and above.
“I’m using miLOOP exclusively when I’m operating,” she said, noting later that a completely phaco-free procedure can be done with MSICS and miLOOP, bringing the fragments through a smaller incision than with typical MSICS.
She also said she finds it useful in small pupil cases.
“I have found it helpful because those cases tend to be the ones where if you don’t get a good chop in the beginning, you end up bowling them out, and it becomes a stressful situation where you’re trying to grab that epinuclear bowl under the pupil and bring it in,” Dr. MacDonald said. “If you can divide the lens into four quadrants and remove those four quadrants with phaco, that small pupil case becomes a simple case.”
Overall, Dr. MacDonald said she thinks learning to use miLOOP is intuitive, which for her, at the start, was the sticking point. “What’s different for me is that with most tools I’ve used in surgery, I’ve had to learn how to efficiently manipulate them. I’ve realized with this tool, I don’t have to develop a technique, but just follow the directions. All I have to do is place the miLOOP in under the anterior capsule and push the button to fully expand it. Once it is fully expanded, I gently sweep the miLOOP between the capsule and the nucleus by rotating my wrist and keeping the instrument centered in the eye. Trusting the instrument was part of my learning curve—understanding that it would follow the directions and it would just work.”
William Wiley, MD, assistant clinical professor of ophthalmology, University Hospitals/Case Western University, Cleveland, who was not involved in the British Journal of Ophthalmology study but did present research on miLOOP at the ASCRS•ASOA Annual Meeting, said he has been using miLOOP for more than a year and is figuring out what cases to use it on—the majority of cases, including routine, or just more complicated situations.
“I can make an argument for either strategy, and we’ve been doing an evaluation to see if we should use it on every case,” he said. At the very least, Dr. Wiley said he sees value in using it in cases of small pupils, thicker or dense cataracts that the femtosecond laser can’t soften, cases where the patient might not be able to afford to upgrade but would benefit from decreased use of phaco energy, and as a rescue tool in chop cases where the first crack proves difficult.
He has done research (not yet published) that found use of miLOOP to prechop the lens reduces the amount of time the phaco handpiece is in the eye and that the I/A tip is in the eye by 20% and 30%, respectively.
“miLOOP takes 20–30 seconds to bisect the nucleus, but you gain a lot of that back by having less phaco and less I/A in the eye, overall decreasing the risk of complications,” Dr. Wiley said.
Dr. MacDonald said she looks forward to larger studies involving miLOOP that evaluate its effect on efficiency in the OR, case times, and surgical times, as well as endothelial cell counts compared to traditional cataract surgery.
In the future, Dr. Wiley thinks miLOOP will be a tool that some surgeons find indispensable in certain situations. Just like some surgeons find iris expansion rings a must-have in certain situations, so too Dr. Wiley said they’ll consider miLOOP.
“I think there will be cases where almost every surgeon will have the opportunity to benefit from it,” Dr. Wiley said.

Reference

1. Ianchulev T, et al. Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomized controlled study. Br J Ophthalmol. 2018 Apr. Epub ahead of print.

Editors’ note: The physicians have financial interests with Iantech.

Contact information

Ianchulev
: tianchul@privatemedicalequity.com
MacDonald: susanmacdonaldeyecorps@gmail.com
Wiley: wiley@cle2020.com

First-in-human randomized controlled study compares phaco with miLOOP and phaco alone First-in-human randomized controlled study compares phaco with miLOOP and phaco alone
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