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Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study
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  • Published on:
    Response to letter
    • Tsontcho Ianchule, MD MPH, Ophthalmic Surgeon, Professor of Ophthalmology, New York Eye and Ear Infirmary of Mount Sinai Mount Sinai Hospital System

    We thank the authors for their careful perusal of our study report and thoughtful observations. We agree that as demonstrated by the large population study1,2 referenced by us and by them, the rate of complications with cataract surgery is non-homogenous and increases dramatically with advanced stage cataracts – as much as 200%+ increase in rate of PCT in cases with high grade cataract, pseudoexfoliation and other comorbidities. In fact, with the co-existence of multiple factors, the compound rate can be even higher.

    Our pilot study was in patients with advanced cataracts and multiple co-existing ocular pathologies and given the small sample size we are not surprised that the study point estimate for the PCT rate may be on the higher end of the overall range demonstrated by the larger population study. In addition, the randomized control design of the clinical trial further validates a PCT rate which was similar for both treatment and control groups. Certainly, an informed reader would appreciate that such a small trial is underpowered to be conclusive regarding the small difference between the two groups so no claims should be made about the slightly better rate of PCT and lower trend demonstrated in the miLOOP group.

    What is important to appreciate from both the population study and our pilot data is that the rate of PCT is not the same for all cataract surgeries and there is a multiplier effect in certain subgroups and subpopulations. Our authorship team...

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    Conflict of Interest:
    patent holder, inventor and founder of the milOOP technology
  • Published on:
    Concerns regarding complication rates of recent prospective investigation
    • David Fleischman, Assistant Professor, Ophthalmology University of North Carolina at Chapel Hill
    • Other Contributors:
      • Andrzej Grzybowski, Chair of Ophthalmology

    We are interested in the work of Ianchulev et al in their recent interventional randomized controlled trial.[1] What piqued our interest was the rate of posterior capsular tears (PCT). 4/53 (7.5%) patients in the miLOOP+phaco group experienced PCT, and 5/48 (10.4%) phaco-alone controls with PCT. These rates are much higher than standard phacoemulsification reports. The authors refer to a large study that identified advanced cataracts increased risk of PCT at comparable levels.[2] That same group published investigations expounding upon this.[3-4] Advanced cataracts were specifically identified as brunescent/white cataracts, contrasting Grade 3-4 in the miLOOP study (curiously described as LOCSIII classification in the manuscript).

    Using the risk calculation,[3] the range of composite adjusted odds ratio (aOR) for the miLOOP study was 49.93 (25-28% risk) to an aOR of 0.87 (<1% surgical risk). The average patient from the miLOOP investigation had an aOR of 4.43, thus <5% PCT risk.

    Our concerns: First, the authors state that “There was a trend towards a lower rate of capsular tear during the phaco portion with miLOOP-assisted phaco (7.5%) compared to standard phaco (10.4%).” Given the numbers representing these percentages this is an inappropriate description of this relationship.

    Let us assume that a control group presented with a PCT rate similar to that reported in literature: <5%. Here, miLOOP-phaco PCT rate would be higher than the control...

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    Conflict of Interest:
    None declared.