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New Clinical Evidence through Five Years: NaturalVue Multifocal

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November 16, 2020

By Sally M. Dillehay, OD, EdD, FAAO
President and Chief Medical Officer, ClinTrialSolutions, LLC

We have yet another reason to be enthusiastic about the new options emerging for pediatric myopia. In September 2020, Visioneering Technologies, Inc. (VTI), maker of the NaturalVue  (etafilcon A) Multifocal 1 Day Contact Lenses, presented at the Global Myopia Symposium positive data through five years showing long-term benefit in myopic children wearing VTI’s NaturalVue Multifocal contact lenses. The importance of the recently presented data is that it shows that in real-world practices, the NaturalVue Multifocal continues to be effective in reducing myopic progression, even through five years (59 months).

The first peer-reviewed and published data with the VTI extended depth of focus, center distance, daily disposable multifocal contact lenses (NaturalVue Multifocal) was from an in-depth retrospective case series analysis in 10 practices throughout the U.S.  The article, “Case Series Analysis of Myopic Progression Control with a Unique Extended Depth of Focus Multifocal Contact Lens,” was published in Eye and Contact Lens Journal: Science and Clinical Practice in 2018.1

Updated Data Show Continued Improvement Through Five Years

These new data add to the previously released data with an increased number of children and practices contributing, longer time points that the children were followed, and data related to the axial length change in a subset of children. The data show that through five years, NaturalVue Multifocal contact lenses continue to help minimize the progression of myopic refractive error in children who are wearing the lenses.  Because not many practitioners had instruments to measure axial length when these children first started wearing the NaturalVue Multifocal, the axial length data goes through three years (35 months) in a smaller sample.

The updated data include 153 children (mean age 12.0 years) followed for 6 to 59 months. The data were consistent at each time point (6 month intervals), demonstrating approximately 0.90D decrease in myopic progression (approximately 90 percent), as compared to the rate of progression of children at these practices prior to wearing NaturalVue Multifocal contact lenses (N=305 eyes). All timepoints were statistically significantly different from baseline (p < 0.00001). Throughout the six through 59 months points in time, the amount of myopia progression in children wearing NaturalVue Multifocal was consistently less than 0.125D.

Within a subset of 36 children, axial length was measured over time. Axial length change from baseline averaged 0.11 + 0.14 mm at one year, 0.20 + 0.20, at two years, and 0.17 + 0.21 at three years. These children showed approximately 0.10mm of axial length growth per year of wearing the NaturalVue Multifocal. These axial length data compare favorably to what would be expected for young children ages 8-12 for normal emmetropization of about 0.10-0.13mm/year.2

We started evaluating this real-world evidence because I was at a conference years ago telling a friend that I was having great results with the lens and seeing very minimal progression of refractive error once the children were wearing NaturalVue Multifocal. A colleague came up and joined the conversation and said, “You must be talking about NaturalVue Multifocal in children, because I’m seeing the same thing.” So, we decided to do a more formal, IRB approved, retrospective cohort analysis of all the children at these practices that had started using the NaturalVue Multifocal as well.

To see five years later that the refractive errors in many of these children are still showing minimal changes over time, and that the axial length growth in those who have been followed over time is essentially the same as we would expect for normal emmetropic growth of the eye, is personally very rewarding. These are young children, and we’ve been able to demonstrate excellent results for slowing down, and in some cases stopping the progression of myopia. In a subset of the data with only 8-12 year-olds, 95 percent of the children showed less than a 0.25D progression of myopia throughout the entire 36-month period.

How Long to Continue Using Intervention to Slow Myopia?

I often get asked as to how long children should continue using interventions aimed at slowing the progression of myopia. A large study out of the University of Waterloo followed 6,400 people and found that the average age when myopia stopped progressing was between 24 and 27 years old.3 I think historically many practitioners think that myopia stops progressing at puberty or around age 14-18.  The COMET study found that at age 15, 50 percent of pediatric myopes were still progressing, and at age 18, 25 percent of myopes were still progressing.4 We can’t predict how any single individual child will respond to any intervention for myopia, but based on averages, we need to keep the children in such interventions likely through their mid-20s.

We all need to be speaking to every myope in our chairs, whether they are children or parents of children, about the very real risks that occur long-term when myopia progresses.5 Just like we speak to patients with family histories of glaucoma or diabetes and other risk factors, we need to do the same for myopia. An analysis of data from 15,000 patients6  demonstrated that each additional 1.00D of myopia is associated with a 25 percent increase in visual impairment.7 With a relationship between increasing myopia and increased frequency of ocular disease and visual impairment becoming more compelling, it is reasonable that reducing myopia should lower the risk for children over the longer term.8

When I started in eye care, myopia was considered “just” a refractive error. But now over time, we realize that it is a leading cause of vision impairment in the U.S.8 The data on multiple interventions is very encouraging that we can change the path of myopic progression for many children.8 Working together, we can all make a difference in the future of these myopic children.

 

 

Sally M. Dillehay, OD, EdD, FAAO, is president and Chief Medical Officer of ClinTrialSolutions, a medical research organization assisting companies with medical device research, clinical trials, submissions to regulatory agencies and medical marketing. Disclosure: Dr. Dillehay is a Consultant to and the former Chief Medical Officer for Visioneering Technologies, Inc.

 

This information may describe uses for multifocal contact lenses that have not been approved or cleared by the FDA for use in the United States.

In the United States, NaturalVue (etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia.

In Europe, Australia, New Zealand, Hong Kong, Singapore, Canada, NaturalVue (etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia, and myopia progression control

References:

  1. Cooper J, O’Connor B, Watanabe R, Fuerst R, Berger S, Eisenberg N, Dillehay SM. Case series analysis of myopic progression control with a unique extended depth of focus multifocal contact lens, Eye & Contact Lens: Science & Clinical Practice: September 2018; 44(5):e16-e24.
  2. Zadnik K, Mutti DO, Mitchell GL, Jones LA, Burr D, Moeschberger ML. Normal eye growth in emmetropic schoolchildren. Optom Vis Sci Nov 2004;81(11):819-828.
  3. Hrynchak PK, Mittelstaedt A, Machan CM, Bunn C, Irving EL. Increase in myopia prevalence in clinic-based populations across a century. Optom Vis Sci 2013 Nov;90(11):1331-1341.
  4. COMET Group. Myopia stabilization and associated factors among participants in the Correction of Myopia Evaluation Trial (COMET). Invest Ophthalmol Vis Sci2013; 54: 7871– 7884.
  5. Bullimore MA & Brennan NA. Myopia control: Why each diopter matters. Optom Vis Sci2019; 96: 463– 465.
  6. Tideman JW, Snabel MC, Tedja MS et al. Association of axial length with risk of uncorrectable visual impairment for europeans with myopia. JAMA Ophthalmol2016; 134:1355– 1363.
  7. Bullimore MA & Ritchey E. Myopia control: An evidence‐based comparison of the benefits and the risks. Optom Vis Sci2019; 96: E‐abstract 190031.
  8. Bullimore MA, & Richdale K. Myopia Control 2020: Where are we and where are we heading? Ophthalmic Physiol Opt 2020;40: 254–270.

MKT-GBL-NVM-AP5 r0; 2021

 

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