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 (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses.
DESIGN, SETTING, AND PARTICIPANTSA double-masked randomized clinical trial that took place at 2 optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with −0.75 D to −5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between
The evidence-basis based on existing myopia control trials along with the supporting academic literature were reviewed; this informed recommendations on the outcomes suggested from clinical trials aimed at slowing myopia progression to show the effectiveness of treatments and the impact on patients. These outcomes were classified as primary (refractive error and/or axial length), secondary (patient reported outcomes and treatment compliance), and exploratory (peripheral refraction, accommodative changes, ocular alignment, pupil size, outdoor activity/ lighting levels, anterior and posterior segment imaging, and tissue biomechanics). The currently available instrumentation, which the literature has shown to best achieve the primary and secondary outcomes, was reviewed and critiqued. Issues relating to study design and patient selection were also identified. These findings and consensus from the International Myopia Institute members led to final recommendations to inform future instrumentation development and to guide clinical trial protocols.
CRT results in reduced low-contrast BCVA as a result of increased higher-order aberrations. Higher-order aberrations appear to be relatively stable after CRT. Spherical aberration appears to drive additional low-contrast BCVA losses as pupil size increases.
The statistically significant, but clinically small, PAL effect suggests that treatments aimed at reducing foveal defocus may not be as effective as previously thought in myopic children with high accommodative lag. Finding no evidence of treatment loss after discontinuing PAL wear supports hyperopic defocus-based theories such as accommodative lag; however, not finding an association between accommodative lag and myopia progression is inconsistent with the PAL effect being due to decreased foveal blur during near work. (Clinical Trials.gov number, NCT00335049.).
PALs caused a myopic shift in peripheral defocus. Superior myopic defocus was associated with less central myopia progression. These data support the continued investigation of optical designs that result in peripheral myopic defocus as a potential way to slow myopia progression. (ClinicalTrials.gov number, NCT00335049.).
These methods of grading meibography images demonstrate good within-reader reliability and fair between-reader reliability. Responsiveness to change will need to be addressed in future studies.
Significance
The Bifocal LensesIn Nearsighted Kids (BLINK) study is the first soft multifocal contact lens myopia control study to compare add powers and measure peripheral refractive error in the vertical meridian, so it will provide important information about the potential mechanism of myopia control.
Purpose
The BLINK study is a National Eye Institute-sponsored, double-masked, randomized clinical trial to investigate the effects of soft multifocal contact lenses on myopia progression. This article describes the subjects' baseline characteristics and study methods.
Methods
Subjects were 7 to 11 years old, had −0.75 to −5.00 spherical component and less than 1.00 diopter (D) astigmatism, and had 20/25 or better logMAR distance visual acuity with manifest refraction in each eye and with +2.50-D add soft bifocal contact lenses on both eyes. Children were randomly assigned to wear Biofinity single-vision, Biofinity Multifocal “D” with a +1.50-D add power, or Biofinity Multifocal “D” with a +2.50-D add power contact lenses.
Results
We examined 443 subjects at the baseline visits, and 294 (66.4%) subjects were enrolled. Of the enrolled subjects, 177 (60.2%) were female, and 200 (68%) were white. The mean (± SD) age was 10.3 ±1.2 years, and 117 (39.8%) of the eligible subjects were younger than 10 years. The mean spherical equivalent refractive error, measured by cycloplegic autorefraction was −2.39 ± 1.00 D. The best-corrected binocular logMAR visual acuity with glasses was +0.01 ± 0.06 (20/21) at distance and −0.03 ± 0.08 (20/18) at near.
Conclusions
The BLINK study subjects are similar to patients who would routinely be eligible for myopia control in practice, so the results will provide clinical information about soft bifocal contact lens myopia control as well as information about the mechanism of the treatment effect, if one occurs.
Contact lenses significantly improved the quality of life, as reported by children and teens using the PREP, and there was not a difference in improvement between children and teens. Contact lens wear dramatically improves how children and teens feel about their appearance and participation in activities, leading to greater satisfaction with their refractive error correction. The improvement in quality of life after contact lens wear indicates that children should be offered contact lenses as a treatment for refractive error as routinely as teens.
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