September 1, 2020
By Dwight Akerman, OD, MBA, FAAO, FBCLA
A study published in the August edition of the Journal of the American Medical Association (JAMA) aimed to determine whether CooperVision Biofinity “D” silicone hydrogel monthly replacement multifocal contact lenses slow myopia progression in children and whether high add power (+2.50D) slows myopia progression more than medium (+1.50D) add power lenses. Although these contact lenses were approved for wear by the U.S. Food and Drug Administration (FDA) without age restriction, they did not have a specific FDA indication for myopia control and were prescribed off label.
A total of 294 consecutive eligible children ages 7 to 11 years old were enrolled. The primary outcome was the three-year change in cycloplegic spherical equivalent autorefraction.
The 43 percent slowing of myopia progression and 36 percent slowing of axial length reported in this study for the +2.50D high add power were in the middle of the ranges previously reported in other randomized controlled studies of multifocal soft lenses. A consensus paper by the International Myopia Institute stated that a 40 percent slowing of myopia progression was clinically meaningful. The +1.50D medium add power demonstrated a 15 percent slowing of myopia progression and a 12 percent slowing of axial length progression.
Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over three years compared with medium add power multifocal and single vision contact lenses. The researchers raise the interesting point that “…the dose-response result exhibited in this study only examined up to a +2.50D add power. Speculation remains about whether add powers outside of the standard range may provide better myopia control.”
Abstract
Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial
Jeffrey J.Walline, OD, PhD; Maria K. Walker, OD, PhD; Donald O. Mutti, OD, PhD; Lisa A. Jones-Jordan, PhD; Loraine T. Sinnott, PhD; Amber Gaume Giannoni, OD; Katherine M. Bickle, OD, MS; Krystal L. Schulle, OD; Alex Nixon, OD, MS; Gilbert E. Pierce, OD, PhD; David A. Berntsen, OD, PhD; for the BLINK Study Group
Importance: Slowing myopia progression could decrease the risk of sight-threatening complications.
Objective: To determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50D) slows myopia progression more than medium (+1.50D) add power lenses.
Design, Setting, and Participants: A double-masked randomized clinical trial that took place at two optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with −0.75D to −5.00D of spherical component myopia and less than 1.00D astigmatism were enrolled between September 22, 2014, and June 20, 2016. Follow-up was completed June 24, 2019.
Interventions: Participants were randomly assigned to wear high add power (n = 98), medium add power (n = 98), or single-vision (n = 98) contact lenses.
Main Outcomes and Measures: The primary outcome was the three-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. There were 11 secondary end points, four of which were analyzed for this study, including three-year eye growth.
Results: Among 294 randomized participants, 292 (99 percent) were included in the analyses (mean [SD] age, 10.3 [1.2] years; 177 [60.2 percent] were female; mean [SD] spherical equivalent refractive error, −2.39 [1.00]D). Adjusted three-year myopia progression was −0.60D for high add power, −0.89D for medium add power, and −1.05D for single-vision contact lenses. The difference in progression was 0.46D (95 percent CI, 0.29-0.63) for high add power vs. single vision, 0.30D (95 percent CI, 0.13-0.47) for high add vs. medium add power, and 0.16D (95 percent CI, −0.01 to 0.33) for medium add power vs. single vision. Of the four secondary end points, there were no statistically significant differences between the groups for three of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was −0.23 mm (95 percent CI, −0.30 to −0.17) for high add power vs. single vision, −0.16 mm (95 percent CI, −0.23 to −0.09) for high add vs. medium add power, and −0.07 mm (95 percent CI, −0.14 to −0.01) for medium add power vs. single vision.
Conclusions and Relevance: Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over three years compared with medium add power multifocal and single vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences.
Trial Registration: ClinicalTrials.gov Identifier: NCT02255474
Walline, J. J.; Walker, M. K.; Mutti, D. O.; Jones-Jordan, L. A.; Sinnott, L. T.; Giannoni, A. G.; … & Berntsen, D. A. (2020). Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial. JAMA, 324(6), 571-580.
