The State of Myopia Management

We are living in the most exciting time to be implementing myopia management in our everyday practices. Not only do we have an FDA-approved daily disposable soft contact lens option, but several other treatment options are on the way that we will be able to add to our arsenal to expand our scope of practice even further. In addition, new evidence-based lifestyle recommendations have surfaced,^1-4 which we can use to supplement our medical myopia control options.

This article explores the newest trends and topics in myopia management.

LIFESTYLE RECOMMENDATIONS

Outdoor Activity

Spending time outdoors has been recognized for years to prevent or delay myopia onset, but the details surrounding what constitutes outdoor time have been ambiguous until recently. The current recommendation is now at least 2 hours per day, but the more time outdoors the better; in fact, children who spent less than 13 hours/week outdoors had significantly higher risk of incident myopia.¹ While outdoors, children should avoid doing any near work and, instead engage in activities that stimulate their distance vision, such as playing sports.

The exact level of light intensity necessary to have an effect on incident myopia is yet to be determined, but traditionally, light intensity more than 1,000 lux is considered sufficient to constitute outdoor time. Thus, even being outdoors on a cloudy day is better than being indoors, in terms of myopia control.

Sleep

Sleep is a key factor in children’s overall health, but it has been recently described as a modifiable behavioral risk factor affecting both myopia onset and progression. According to two recent studies, there is an increased risk of myopia in children who sleep less than 5 to 7 hours per night compared with those who sleep more than 9 hours per night.^2,3 In addition, results from a trial conducted in China found that children who had a bedtime of 9:30 pm or later were much more likely to be myopic at baseline, develop myopia during the 2-year trial, and have more significant myopic progression.⁴ These results suggest that children who have an earlier bedtime and sleep longer are less likely to become myopic and to progress at a slower rate if they do develop myopia.

FDA-APPROVED CONTACT LENS

MiSight 1 day (CooperVision) is the first FDA-approved soft contact lens proven to slow the progression of myopia in children from 8 to 12 years of age at the initiation of treatment. At 3 years, the trial evaluating this lens concluded that children wearing MiSight 1 day experienced on average a 59% reduction in refractive progression and a 52% reduction in axial elongation compared with the control group.⁵ Most recently, the company released 7-year data showing that, despite being switched into a single-vision lens for the final year, there was no evidence of a rebound effect after cessation of treatment.⁶ In addition, 23% of children who wore MiSight 1 day lenses for the full 6 years showed essentially no myopia progression (ie, < 0.25D) throughout the trial.⁷

Although MiSight 1 day is the only FDA-approved contact lens option for myopia control, there are several other highly effective lens designs available for off-label use, such as orthokeratology lenses and center-distance soft multifocal contact lenses.

NOVEL TREATMENTS IN DEVELOPMENT

Light Therapy

Although true outdoor time is ideal, there are challenges that may prevent children and their families from spending 2 or more hours per day outside, such as inclement weather, lack of proper supervision, and time constraints. As a result, researchers have proposed an indoor therapy using repeated low-level red light that could potentially mirror the positive effects of outdoor time.⁸ In a sham device-controlled, randomized, double-blind clinical trial in China, researchers used a device that emits 650 nm of red light directly to the retina. The therapy was administered at home under parental supervision twice daily, 5 days per week. Each session lasted 3 minutes, with the sessions separated by a minimum of 4 hours. The preliminary results of this study are promising, with a significant decrease in axial elongation and myopia progression after 6 months and no structural effects on the retina.⁸

Pharmaceutical Therapy

Low-dose atropine has been used for decades as an effective off-label form of myopia control. Studies such as Low-concentration Atropine for Myopia Progression (LAMP)⁹ and Atropine for the Treatment of Childhood Myopia¹⁰ have been invaluable in determining the appropriate dosing and concentration of this nonselective muscarinic antagonist for clinical use.

The Childhood Atropine for Myopia Progression (CHAMP) trial is moving us one step closer to having an FDA-approved formulation (NVK002, Vyluma).¹¹ This is a three-arm, randomized, double-masked, placebo-controlled clinical trial testing several atropine formulations that are shelf stable at room temperature, preservative-free, and dosed once daily at night.

With sites in the United States and Europe, the trial includes patients from 3 to 17 years of age from a variety of ethnic backgrounds who have myopia between -0.50 DS and -6.00 DS and no more than -1.50 D of astigmatism. The trial is in phase 3 and has determined that low dose formulations of 0.01% and 0.02% are safe with few adverse events. In addition, 0.01% atropine was found to be efficacious in slowing myopia progression, as evidenced by spherical equivalent refractive error and axial length measurements when compared with placebo after 3 years.^12,13 If approved, this drop would be the first pharmaceutical agent approved for the treatment of childhood myopia progression.

Spectacle Options

Myopia control spectacles are perhaps the most anticipated addition to our myopia management toolbox. These would provide a complete package of options for our patients and would especially help those who are both contact lens and eye drop averse. Although they are already available in many other countries, they are not yet available here in the United States. There are three leading design options in development: MiyoSmart (Hoya Vision), Stellest (Essilor), and SightGlass (SightGlass Vision).

MiyoSmart spectacle lenses use Defocus Incorporated Multiple Segments technology developed in collaboration with the Hong Kong Polytechnic University and is considered to have a dual focus design.¹⁴ The lens consists of a central optical zone for distance correction with approximately 400 plus powered (+3.50) lenslets equally distributed in a honeycomb pattern throughout the midperipheral zone. This design provides clear distance vision, while simultaneously creating myopic defocus on the peripheral retina.

Stellest lenses incorporate Highly Aspherical Lenslet Target technology, with the lens consisting of a single vision optical zone surrounded by 11 rings of aspheric lenslets of varying powers to create a volume of myopic defocus.¹⁵

SightGlass uses Diffusion Optics Technology to reduce contrast. This lens design is based on the theory that high levels of contrast on the retina cause axial elongation, whereas low levels slow elongation. The lens consists of a clear central aperture surrounded by thousands of dots, reducing peripheral retina contrast by at least 30% when compared to central contrast.¹⁶

OPPORTUNITIES ABOUND

The future of myopia management is exciting. Practitioners are better equipped now than ever to adopt myopia management as standard of care and to have a positive influence on the lives and vision of our patients.