Prospective Study for NaturalVue® Multifocal Demonstrates Decreased Refractive Error Change in Fast-Progressing Myopic Children
Thomas Aller, OD, recognized as a global expert in the field of myopia, presented updated findings from a prospective clinical trial of NaturalVue® (etafilcon A) 1 Day Multifocal Contact Lenses at a Briefing for Media and Industry Leaders at the American Academy of Optometry (AAO) Conference in San Antonio November 9. The NaturalVue portfolio of products were developed by Visioneering Technologies, Inc. (ASX: VTI), a global company dedicated to improving vision.
Dr. Aller, who is a practicing optometrist and Visiting Scholar at the UC Berkeley School of Optometry, highlighted how VTI’s unique center distance, extended depth of focus multifocal lens design continues to show promise in managing myopia in children.
In October 2017, the first long-term data were published on the use of the NaturalVue Multifocal to decrease the progression of myopic refractive error in children. Published in the peer-reviewed journal, Eye & Contact Lens, the study was a retrospective case series analysis from 10 practice locations following children for 6-25 months after wearing NaturalVue Multifocal.1 These data demonstrated a 96% decrease in the rate of myopic progression among 32 children, ages 6-19. Additional retrospective case series data from 27 children at 3 practice locations were presented at the Global Specialty Lens Symposia in January 2018.2
Starting in 2017, Dr. Aller spearheaded a prospective, registered clinical trial (NCT03358862) with the objective of identifying change in refractive error as well as axial length growth in myopic children wearing NaturalVue Multifocal. To date, 24 children have completed at least one 6 month follow up visit, and 19 children have worn the lens for at least one full year or longer. The average age of this sample population was 10.8 + 2.7 years old with most of the children (50%) having some Asian ethnicity.
Prior to wearing NaturalVue Multifocal, the children were progressing in their myopic refractive error -1.28 + 0.79D per year. Overall, the children demonstrated a statistically significant (P<0.01) average of 1.04D (81%) per year decrease in myopic refractive error change. Using published estimates of axial length change based on the prior year’s refractive error (1 mm=3.00 D)3, these children would have been predicted to have shown an increase in axial length of 0.43 + 0.26 mm in the year prior to wearing NaturalVue MF. With NaturalVue MF, the 19 children who have worn the lens for at least one year demonstrated an axial length change of 0.20 + 0.19 mm in one year, a favorable difference to what would have been expected given their high rate of refractive error change observed prior to wearing NaturalVue MF. These preliminary data are encouraging with respect to the potential reduction of axial length growth.
With Dr. Aller’s data, the 3 cohorts of children had an average follow up period of 12 months, with some reaching 36 months in 2018. On average, 97% of these children showed a decrease in the amount of refractive error change, with an average decrease of 0.93D/year.
“Identifying better ways to manage myopia has become a top priority for vision care experts worldwide. The prevalence of myopia is increasing among children globally at alarming rates,” said Dr. Aller.
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. 44(5):e16-e24, September 2018
2 O’Connor, B, Jeruss J, Aller T, Dillehay SM. Myopia Management with A Unique Extended Depth of Focus Contact Lens: A Case Series Analysis. Paper presented at Global Specialty Lens Symposia. January, 2018.
3 Lam AK, Chan R, Pang PC. The repeatability and accuracy of axial length and anterior chamber depth measurements from the IOLMaster. Ophthalmic Physiol Opt. 2001;21(6):477-483.
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