Soft dual focus contact lenses significantly cut the rate of myopia progression in kids over the long-term versus other types of lenses, researcher reported.
In the BLINK trial in almost 300 children, commercially available center-distance soft multifocal contact lenses with a high add power slowed myopia progression by 0.45 D and eye growth by 0.23 mm compared with single-vision contact lenses, and slowed myopia progression by 0.29 D and eye growth by 0.16 mm compared with medium add power multifocal contact lenses over 3 years, according to Jeffrey J. Walline, OD, PhD, of The Ohio State University College of Optometry in Columbus, and co-authors.
“The high add power did not clinically alter the ability to see or result in a greater number of adverse events,” they wrote in JAMA.
Walline’s group explained that in American children, myopia typically begins between ages 8 and 10 years, with progression into the mid-teen years. “Myopia is associated with sight-threatening ocular sequelae, such as cataracts, retinal detachment, glaucoma, and choroidal atrophy. Effective myopia control measures should therefore be implemented to reduce the risks associated with increasing myopia prevalence and high societal costs,” they stated.
BLINK built on conclusions from other trials that were smaller with shorter follow-up, noted Neil M. Bressler, MD, of Johns Hopkins University School of Medicine in Baltimore, in an editorial accompanying the study.
But there is little evidence from BLINK and other studies that soft multifocal contact lenses prevent pathologic myopia, he said.
“Furthermore, with follow-up only to 3 years [in BLINK], whether the effects will persist through adulthood to reduce the development of pathologic myopia or whether discontinuation of the high add power lenses results in loss of the effects are unknown,” Bressler pointed out.
He praised BLINK for its contribution to the field of pediatric myopia research, but said he remains cautious about soft contact lens correction as a standard of care, explaining that “the answers to questions regarding longer-term effects on reducing the risk of axial elongation and pathologic myopia seem warranted before soft contact lens correction to reduce myopia progression becomes standard care.”
The trial took place at two optometry schools in Columbus, and Houston, and enrolled 294 consecutive eligible children (mean age 10.3 years; 60.2% female), with −0.75 D to −5.00 D of spherical component myopia (mean −2.39) and less than 1.0 D astigmatism from 2014 through 2016. Follow-up was completed in June 2019.
The authors sought to determine if soft multifocal contact lenses could slow myopia progression in children, and whether high add power (+2.50 D) slowed myopia progression more than medium (+1.50 D) add power lenses.
The children were randomly assigned in three groups of 98 participants each to wear high add power, medium add power, or single-vision (control group) contact lenses.
The primary outcome of BLINK was a 3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. Secondary outcomes included axial elongation, visual acuity, adverse events, and adherence.
Of the original cohort, 292 were included in the analyses, with 287 completing the 3-year visit.
The investigators found the adjusted 3-year myopia progression was −0.60 D for high add power, −0.89 D for medium add power, and −1.05 D for single-vision contact lenses.
The difference in progression was 0.46 D (95% CI 0.29-0.63) for high add power versus single vision, 0.30 D (95% CI 0.13-00.47) for high add versus medium add power, and 0.16 D (95% CI −0.01 to 0.33) for medium add power versus single visions, they reported.
They also noted that the percentage of participants who progressed −1.00 D or more during the study was 16.8% (95% CI 9.9%-25.9%) for the high add power group, 36.5% (95% CI 26.9%-46.9%) for the medium add power group, and 51% (95% CI 40.6%-61.4%) for the single-vision group.
In four secondary endpoints, the authors said they found no statistically significant differences for visual acuity, adverse events, and adherence. However, for axial elongation, the 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.
Finally, the difference in eye growth was:
- −0.23 mm for high add power versus single vision (95% CI −0.30 to −0.17).
- −0.16 mm for high add versus medium add power (95% CI −0.23 to −0.09).
- −0.07 mm for medium add power versus single vision (95% CI, −0.14 to −0.01).
Study limitations included an adjusted myopic progression −1.05 D in the control group, which the authors noted is slower than the 3-year progression of other single-vision contact lens or spectacle wearers in the U.S. But they said this may have been because only 9% of the BLINK participants reported Asian ethnicity and Asian children progress faster.
Also, the contact lenses in BLINK were not individually adjusted for the amount of myopic defocus and the duration of BLINK did not allow measurement of the participants’ ultimate myopia. The dose-response result only examined up to a +2.50 D add power, the authors stated.
Treatment with high add power multifocal contact lenses compared with medium add power multifocal and single-vision contact lenses reduced the rate of myopia progression over 3 years.
More data are needed on longer-term effects on reducing the risk of axial elongation and pathologic myopia before soft contact lens correction to reduce myopia progression becomes standard care.
Shalmali Pal, Contributing Writer, BreakingMED™
Bausch+ Lomb provided contact lens solutions for the study.
Walline reported support from the NIH, Bausch + Lomb, and the National Eye Institute (NEI) as well as a relationship with SightGlass. Co-authors reported support from, and/or relationships with, NEI, Bausch+ Lomb, Welch Allyn, Visioneering Technologies and Contact Lens Spectrum.
Bressler reported support from Bayer, Biogen, F. Hoffman-LaRoche, Novartis, Regeneron, and Samsung Bioepis to Johns Hopkins University.
Cat ID: 240
Topic ID: 92,240,730,138,139,192,240