Slowing Nearsightedness in Children: A Patient's Guide to the MiSight Contact Lens

Table of Contents

• Key Points
• Understanding Myopia: What It Is and Why It Matters
• The Growing Burden of Myopia in Children
• Current Treatment Options and Gaps
• Meet MiSight: Design, Specifications, and How It Works
• Evidence Behind FDA Approval: The Key Studies
• Clinical Implications: What This Means for Patients
• Study Limitations: What the Research Couldn't Prove
• Recommendations for Patients and Parents
• Frequently Asked Questions
• Source Information

Key Points

• Myopia affects 30% of the world and may reach 50% by 2050; early progression raises risks of severe eye disease.
• MiSight contact lenses are FDA-approved for children aged 8–12 with myopia -0.75 to -4.00D and astigmatism ≤0.75D.
• Clinical trials showed MiSight reduced myopia progression by 39–59% and axial elongation by 36–52% versus controls.
• No serious ocular adverse events occurred in trials; real-world data from 782 children showed corneal ulcer rates comparable to adults.
• Low-dose atropine (60–77%), orthokeratology (37–56%), and MiSight (25–79%) are effective; outdoor time complements treatment.

Understanding Myopia: What It Is and Why It Matters

Myopia, commonly called nearsightedness, is the most common refractive error in adolescents and young adults worldwide. From an optical standpoint, myopia occurs when light rays entering the eye parallel to the optic axis focus in front of the retina instead of directly on it when the eye is at rest. This typically results from the eyeball being too long from front to back, though it can also be caused by an overly curved cornea or a lens with increased optical power. Simply put, close objects appear clear while distant objects look blurry.

Researchers classify myopia in several ways. Axial myopia is caused by excessive elongation of the eyeball — this is the most common type and the one that myopia control treatments target. Refractive myopia results from changes in the structure or position of the eye's image-forming parts (the cornea and lens). Secondary myopia occurs due to a specific identifiable cause such as a drug, corneal disease, or systemic clinical syndrome, and is not a recognized population risk factor for ordinary myopia development.

The diagnostic threshold for myopia, according to Flitcroft and colleagues, is a spherical equivalent refractive error of no greater than −0.50 diopters (D) in either eye. High myopia is defined as a spherical equivalent of no greater than −5.00D in either eye. High or pathologic myopia is also often described as having an axial length (the front-to-back length of the eye) greater than 26–27 millimeters, which is typically associated with abnormal elongation and progressive degeneration of the retina and choroid at the back of the eye.

Pathological myopia has an estimated global prevalence of 0.2–3.8%, though varying definitions used in early studies limit direct comparison of findings across regions. Visual impairment related to pathological myopia has been reported in 0.1–0.5% of European study populations and 0.2–1.4% of Asian study populations.

Myopia is a multifactorial condition that arises from a complex interplay between genetics and environment. The gene–environment interaction is the basis of what experts call "simple" or "school" myopia, where the eye completes its normal developmental process (emmetropisation) but then continues to grow abnormally for reasons not yet fully understood. By contrast, pathological myopia may be present at birth or appear in the first years of life independent of this interaction. It's important to note that myopia control methods, including MiSight, show evidence of efficacy specifically for the former type, not the latter.

Parental myopia is a well-documented risk factor. A meta-analysis by Zhang and colleagues examined the odds of having a child with myopia and found the following:

• One parent with myopia: odds ratio (OR) of 1.53 (95% CI 1.21–1.85) in prospective cohort studies, 1.96 (95% CI 1.53–2.39) in cross-sectional studies, and 2.13 (95% CI 1.79–2.46) in case–control studies.
• Two parents with myopia: odds ratio of 2.10 (95% CI 1.42–2.77) in prospective cohort studies, 2.96 (95% CI 2.21–3.71) in cross-sectional studies, and 2.13 (95% CI 1.79–2.46) in case–control studies.

Yet the rapid rise in myopia prevalence over recent decades cannot be explained by genetics alone. Environmental factors such as excessive close-up work, limited sunlight exposure early in life, and higher levels of education play a significant role. A younger age at myopia onset is the main factor contributing to faster progression during childhood — a factor that remains significant regardless of sex, ethnicity, time spent reading, or parental myopia.

Once myopia starts, it typically continues progressing into the late teens and early adulthood. Progression is greatest between ages 8 and 15 due to continued growth of the eyeball during childhood. The earlier myopia appears, the faster it tends to progress, and the higher the final level of myopia is likely to be. This is why early intervention matters so much.

The Growing Burden of Myopia in Children

Myopia currently affects at least 30% of the world's population, making it the most common refractive error in adolescents and young adults in most parts of the world. Recent meta-analyses suggest that nearly half of the world's population may be myopic by 2050, with as much as 10% having high myopia. The increase in prevalence is especially steep among East Asian populations compared with similarly aged white populations.

The problem goes far beyond needing glasses. As the eyeball elongates, the retinal epithelium, choroid, and sclera (the white outer coat of the eye) stretch and become thinner. This mechanical stress increases the risk of sight-threatening complications, particularly in people with high myopia. Potential complications include:

• Chorioretinal atrophy (thinning and degeneration of the retina and choroid)
• Foveoschisis (splitting of the retinal layers at the center of vision)
• Choroidal neovascularisation (abnormal blood vessel growth under the retina, or CNV)
• Rhegmatogenous retinal detachment (a tear in the retina leading to detachment)
• Myopic maculopathy (damage to the central retina)
• Glaucoma and cataracts

Each of these conditions can lead to visual impairment and even blindness. The greatest myopia-related cause of irreversible vision loss is myopic maculopathy, characterized by stretched blood vessels, peripapillary atrophy, posterior staphyloma, lacquer cracks in Bruch's membrane, geographic atrophy of the retinal pigment epithelium and choroid, subretinal hemorrhages, and CNV. In countries such as Japan, myopic macular degeneration accounts for 12.2% of all visual impairment.

Importantly, the risks are not limited to people with high myopia, nor only to older adults. CNV is a common cause of vision loss in people of working age and frequently results in irreversible central vision loss. The socioeconomic impact is particularly significant in Asian countries, where the prevalence and severity of pathological myopia are rising dramatically.

Research modeling predicts that a myopia control strategy that delays myopia onset or progression by 30–40% could substantially reduce the future risk of high myopia and its associated ocular complications. For example, slowing myopia by just 1 diopter (1D) is estimated to reduce the likelihood of a patient developing myopic maculopathy by 40%. This is why progressive myopia should no longer be viewed as a simple refractive error that spectacles can fix, but rather as a serious ocular disease that can become irreversible — and why slowing myopia progression has become one of the most important goals in current myopia research.

Current Treatment Options and Gaps

Several categories of treatments — optical, pharmacological, environmental/behavioral, and surgical — have been studied to prevent or delay the onset of myopia and to slow its progression. Evidence from multiple meta-analyses shows that increasing time spent outdoors correlates with a decreased prevalence of myopia. Once a child is already myopic, however, progression can be significantly reduced by a range of interventions compared with single-vision spectacles or placebo.

Low-dose atropine eye drops have been shown to be the most effective intervention for slowing myopic progression in children, with efficacy between 60% and 77% across various studies. Atropine was first used for this purpose in the 1920s. While historically, atropine 1% effectively controlled myopia progression, it caused significant side effects including photophobia (light sensitivity), poor near vision, dry mouth, flushing, and allergic reactions. Recent studies have demonstrated that much lower doses — 0.01% and 0.05% eye drops — offer a more favorable safety and efficacy balance. Depending on dose, atropine's efficacy ranges widely from around 0.50D per year reduction to much higher figures.

Other interventions with proven efficacy are summarized below, compared against single-vision spectacles as a control:

• High efficacy (greater than 0.50D/year reduction): Atropine 1%, 0.5%, 0.1%, 0.05%, 0.025%, and 0.01%; Pirenzepine 2%.
• Moderate efficacy (0.25 to 0.50D/year reduction): Orthokeratology (corneal reshaping lenses); peripheral defocus contact lenses; peripheral defocus ophthalmic (spectacle) lenses.
• Low efficacy (0 to 0.25D/year reduction): Bifocal or progressive addition spectacles; increased outdoor activities.

These figures come from a network meta-analysis of 30 randomized controlled trials. In terms of how these compare numerically: orthokeratology shows efficacy between 37% and 56%, peripheral defocus-modifying contact lenses between 25% and 79%, and bifocal or progressive addition spectacle lenses average about 19% efficacy.

Promising recent results have also been published for defocus incorporated multiple segments (DIMS) spectacle lenses. In a 2-year study of children aged 8 to 13 with myopia between −1.00 and −5.00D and astigmatism no greater than 1.50D, axial elongation was 0.21 ± 0.02 mm in the DIMS group versus 0.55 ± 0.02 mm in the control group wearing monofocal lenses. Myopia progressed 52% less in diopters and 62% less in ocular axial growth in the study group. A multicenter clinical trial began in China this year to compare DIMS lenses with progressive addition lenses (PALs), aiming to recruit 600 Chinese children aged 6 to 12 for a 3-year follow-up.

Understanding why these treatments work requires a brief explanation of the peripheral defocus theory. Many animal and human studies support the hypothesis that hyperopic defocus (blur) in the peripheral retina drives central axial myopia. When the peripheral retina receives a signal that images are focusing behind it, this appears to stimulate axial elongation, making the eye longer and more myopic. Conversely, inducing myopic defocus (images focusing in front of the peripheral retina) appears to slow eye growth. Orthokeratology works by reshaping the cornea overnight with specially designed rigid gas permeable lenses, inducing relative myopic shifts in peripheral refractive errors to slow progression. Soft multifocal contact lenses and DIMS spectacles work on similar principles.

Multifocal soft contact lenses (MFSCL) fall into three design categories: bifocal concentric lenses (which use a central correction zone surrounded by rings of plus power), peripheral gradient lenses (which produce progressively increasing peripheral myopic defocus toward the lens edge), and extended depth of focus (EDOF) lenses (which improve image quality at and in front of the retina while degrading images behind the retina to prevent axial elongation). MiSight belongs to the first group — bifocal concentric or "dual focus" lenses.

The protective effect of sunlight on eye growth also deserves mention. Research suggests that dopamine levels — which rise with bright light exposure — slow the elongation of the eyeball, while low dopamine levels are associated with longer eyes and myopia. Therefore, spending more time outdoors could complement any other myopia control treatment.

Meet MiSight: Design, Specifications, and How It Works

MiSight 1-day (manufactured by CooperVision) is a daily replacement hydrophilic (water-containing) soft contact lens made of a material called Omafilcon A. It is designed to be worn during the day and discarded after each removal. The lens is clinically proven and FDA-approved for two purposes: correcting myopia and slowing its progression in children with non-diseased eyes who are aged 8 to 12 at the start of treatment, with a refraction of −0.75 to −4.00D (spherical equivalent) and no more than 0.75D of astigmatism. These approval parameters are based on clinical studies in which participants were between the ages of 8 and 12 at initial fitting.

Key specifications of the MiSight lens include:

• Diameter/base curve: 14.2 mm / 8.7 mm
• Water content: 60%
• Center thickness (at −3.00D): 0.09 mm
• Oxygen permeability (Dk/t): 36.6
• Use regime: Daily wear
• Replacement schedule: Daily (one lens per eye per day)
• Power range: −0.25 to −6.00 diopters in 0.25 steps
• Packaging: 30 lenses per box
• Tint: Light blue (for visibility during handling)

The optical design is what sets MiSight apart from ordinary contact lenses. The lens contains a large central correction zone of 3.36 mm diameter, surrounded by concentric rings of alternating distance and near powers. Together, these zones create two focal planes. The correction zones fix the child's refractive error, while the treatment zones produce 2.00 diopters of simultaneous myopic retinal defocus during both distance and near viewing. In plain terms, while the child sees clearly through the central zone, the surrounding rings send a signal to the peripheral retina that discourages the eye from growing longer. The central correction area is deliberately sized to maintain good distance visual acuity, while the near-power rings act as treatment zones to prevent myopic progression by imposing myopic defocus on the peripheral retina as a stimulus to slow eye growth.

Evidence Behind FDA Approval: The Key Studies

The FDA's approval of MiSight was based on efficacy data from a randomized clinical trial conducted in four different countries, plus real-world evidence. Two pivotal clinical trials quantified the effectiveness of MiSight for slowing juvenile-onset myopia progression. In both trials, the primary effectiveness outcomes were changes in cycloplegic spherical equivalent refractive error (measured with eye drops that temporarily paralyze the focusing muscles) and axial length.

The 2-Year Spanish Trial. This study (ClinicalTrials.gov Identifier NCT01917110) compared myopia progression in children randomized to MiSight contact lenses versus single-vision (SV) spectacles over a 2-year period. Children aged 8 to 12 with myopia (−0.75 to −4.00D sphere) and astigmatism (less than 1.00D cylinder) were assigned to either the MiSight group or the control group. Results were published in 2018. A total of 46 children were assigned to the MiSight group and 33 to the single-vision spectacle group, with 74 children completing the trial overall.

After 2 years of follow-up, both myopia progression and axial length growth progressed significantly more slowly in the MiSight group than in the control group. Specifically, MiSight produced 39.32% lower myopia progression and 36.04% lower axial growth of the eye compared to spectacle use over 2 years.

The 3-Year Multicenter Trial. Chamberlain and colleagues conducted a 3-year randomized controlled trial at four investigational sites in Portugal, the United Kingdom, Singapore, and Canada. This study also demonstrated that MiSight contact lenses were effective in slowing myopia progression in children compared with control groups. After 3 years of follow-up, myopia progressed more slowly in the MiSight group (0.45D versus 0.74D, p<0.001), and there was less axial elongation compared to the single-vision control group (0.28 mm versus 0.44 mm, p<0.001). In other words, MiSight showed less refractive error change by 0.73D and less axial elongation by 0.32 mm at 36 months compared with single-vision control contact lenses.

A particularly encouraging finding from the Chamberlain trial was that children who had worn single-vision 1-day contact lenses for the first 3 years and then switched to MiSight for a subsequent period showed less myopia progression, indicating that MiSight is also effective when beginning myopia management at an older age.

Safety Data. Across the clinical trials by Ruiz-Pomeda and Chamberlain, there were no serious ocular adverse events in any of the study groups. These results show that proper use of MiSight contact lenses can be a safe option for myopia correction in children. The MASS study emphasized that treatment success requires a combination of proper lens fitting, good adherence to routine follow-up visits, and timely treatment of any complications.

To further estimate the rate of vision-threatening corneal infections (corneal ulcers) among children and adolescents who wear soft contact lenses daily, the FDA also reviewed real-world data from a retrospective analysis of medical records from 782 children aged 8 to 12 years old at seven community eye care clinics. The results showed a rate of corneal ulcers comparable to the rate seen among adult daily soft contact lens wearers — reassuring evidence that daily disposable lenses in this age group do not appear to carry an elevated risk of serious infection.

Clinical Implications: What This Means for Patients

The evidence reviewed here carries several important messages for parents and eye care professionals. First, myopia in childhood is not just a nuisance that requires glasses — it is a progressive condition that can lead to serious, potentially irreversible eye disease later in life. The earlier myopia begins, the faster it typically progresses, and the greater the final risk of complications like myopic maculopathy, retinal detachment, glaucoma, and cataracts.

Second, effective interventions now exist. Low-dose atropine has shown the highest efficacy (60–77%), followed by orthokeratology (37–56%), peripheral defocus contact lenses like MiSight (25–79% depending on the study), and bifocal or progressive spectacles (around 19%). MiSight offers a unique advantage: it is a soft daily disposable lens, which eliminates cleaning and disinfecting routines, provides a fresh sterile lens every day, and may be easier for children to adapt to than rigid gas permeable orthokeratology lenses worn overnight.

Third, the benefits extend beyond the childhood years. Because the greatest myopia progression occurs between ages 8 and 15, intervening during this window has the potential to reduce a child's final myopia by a meaningful amount. As noted earlier, slowing myopia by just 1D is estimated to cut the risk of myopic maculopathy by 40%. The modeling data suggest that a strategy that delays myopia by 30–40% could substantially reduce the risk of high myopia and its associated complications in adulthood.

For families considering MiSight, the FDA approval parameters matter. The lens is specifically approved for children aged 8 to 12 at the start of treatment, with myopia between −0.75 and −4.00D and astigmatism no greater than 0.75D. Children outside these parameters, or those with eye diseases, would not be candidates based on the current evidence.

Study Limitations: What the Research Couldn't Prove

This article is a narrative review of existing evidence, not a new clinical trial. As with all research, there are important limitations to keep in mind when interpreting the findings.

The definition of myopia and high myopia varies across studies, which limits direct comparison of prevalence figures and treatment outcomes. Pathological myopia prevalence estimates, in particular, are complicated by inconsistent definitions used in earlier epidemiological work.

The clinical trials supporting MiSight followed children for 2 to 3 years. We do not yet have long-term data on whether the slowing effect persists into the late teens, whether children "catch up" with accelerated progression after discontinuing the lenses, or what the ultimate final refraction will be years after treatment ends. The studies also involved relatively small sample sizes in some groups (for instance, 46 children in the MiSight group of the Spanish trial), and the results may not generalize to all ethnicities or geographic regions, especially given evidence that myopia prevalence and progression patterns differ between East Asian and white populations.

It is also important to note that the peripheral defocus theory, while strongly supported by animal and human studies, remains a theory. The exact mechanisms by which peripheral defocus influences axial elongation are still being worked out.

Finally, this review focuses on efficacy and safety within clinical trial settings. Real-world success depends on proper lens fitting, consistent wear, good hygiene, and regular follow-up care. Not every child will be a suitable candidate, and parental supervision of lens handling is essential.

Recommendations for Patients and Parents

If your child has been diagnosed with myopia, or if you are concerned about the risk of myopia development, here are practical steps to consider based on the evidence reviewed:

1. Schedule a comprehensive eye examination. Early detection matters. An eye care professional can measure your child's refractive error, axial length, and overall eye health, and determine whether myopia control treatment is appropriate.
2. Discuss myopia control options with your eye doctor. Ask specifically about low-dose atropine eye drops, orthokeratology, peripheral defocus contact lenses like MiSight, DIMS spectacle lenses, and progressive addition spectacles. Each option has different efficacy, safety, cost, and lifestyle considerations.
3. If considering MiSight, verify candidacy. The FDA-approved indication covers children aged 8 to 12 at the start of treatment, with myopia of −0.75 to −4.00D and astigmatism of 0.75D or less. Children outside this range may still benefit from other myopia control strategies.
4. Prioritize outdoor time. Increasing daily outdoor activity is one of the few interventions shown to reduce the risk of myopia onset, and it can complement other treatments. Aim for at least 1–2 hours of outdoor time per day when possible.
5. Reduce excessive near work when practical. Encouraging regular breaks from close-up activities like reading and screen use is a sensible precaution, even though the evidence is less definitive than for outdoor time.
6. Follow up consistently. Myopia control is a long-term strategy. Regular follow-up visits allow your eye care professional to monitor progression, adjust treatment, and manage any complications early. The MASS study specifically highlighted that proper lens fitting, adherence to follow-up schedules, and timely treatment of complications are critical to success.
7. Understand the safety profile. The clinical trials reported no serious ocular adverse events with MiSight, and real-world FDA data from 782 children showed a rate of corneal ulcers comparable to adult daily soft contact lens wearers. Daily disposable lenses reduce but do not eliminate infection risk — good hygiene and prompt attention to redness, pain, or blurred vision are essential.

Myopia in childhood is a serious, progressive condition with lifelong implications — but it is also a condition we can now do something about. The MiSight contact lens, along with other evidence-based treatments, offers families a genuine opportunity to slow their child's myopia progression, reduce the final level of myopia, and lower the future risk of sight-threatening complications. Discussing these options with an eye care professional is the first step toward protecting your child's vision for decades to come.

Frequently Asked Questions

What is myopia (nearsightedness) and why is it a concern for children?

Myopia occurs when light focuses in front of the retina, making distant objects blurry, often because the eyeball is too long. In children, early-onset myopia tends to progress quickly, increasing future risks of sight-threatening conditions like retinal detachment, glaucoma, and myopic maculopathy.

How does the MiSight contact lens work to slow myopia progression?

MiSight is a daily disposable soft lens with concentric rings that create two focal planes: one corrects vision, the other delivers 2.00 diopters of myopic defocus to the peripheral retina. This signal discourages the eyeball from elongating, slowing myopia progression while maintaining clear central vision.

Which children are eligible for MiSight based on FDA approval?

MiSight is FDA-approved for children aged 8 to 12 at the start of treatment who have non-diseased eyes, myopia between -0.75 and -4.00 diopters, and astigmatism no greater than 0.75 diopters. Children outside these parameters should discuss other myopia control options with an eye care professional.

Is MiSight safe for children? What are the risks?

In clinical trials, no serious ocular adverse events occurred with MiSight. Real-world FDA data from 782 children found a rate of corneal ulcers similar to adult daily soft contact lens wearers. Daily disposable lenses reduce infection risk but do not eliminate it; proper hygiene and prompt attention to redness, pain, or blurred vision are essential.

How does MiSight compare to other myopia treatments like atropine drops?

Low-dose atropine eye drops show the highest efficacy (60–77%) for slowing myopia progression. Orthokeratology shows 37–56%, peripheral defocus contact lenses like MiSight show 25–79%, and bifocal spectacles average about 19%. MiSight offers the convenience of a daily disposable lens without the cleaning required for orthokeratology.

What should parents do if they are considering MiSight for their child?

First, schedule a comprehensive eye exam to confirm myopia and assess axial length. Ask your eye doctor about all myopia control options, including MiSight, atropine, orthokeratology, and DIMS spectacles. If MiSight is appropriate, ensure proper fitting, consistent wear, and regular follow-up visits. Also encourage daily outdoor time of 1–2 hours.

When should a parent seek a second opinion about starting MiSight contact lenses for a child's nearsightedness?

Seek a second opinion if your child is outside the approved age range of 8 to 12, has myopia outside −0.75 to −4.00D, or has astigmatism above 0.75D, because the evidence supports MiSight only within those parameters. Also consider a second opinion if your doctor presents MiSight as the only option and does not discuss alternatives such as low-dose atropine drops, orthokeratology, or DIMS spectacles, which have different efficacy. A second opinion can help you weigh the trade-offs. Diagnostic Detectives Network provides independent expert second opinions.

Source Information

Original Article: "Slowing the Progression of Myopia in Children with the MiSight Contact Lens: A Narrative Review of the Evidence"

Authors: Alicia Ruiz-Pomeda, César Villa-Collar

Journal: Ophthalmology and Therapy (Ophthalmol Ther), 2020, Volume 9, pages 783–795

DOI: https://doi.org/10.1007/s40123-020-00298-y

Published: September 11, 2020 (received August 25, 2020)

Funding/Disclosures: The original article is published under the Creative Commons Attribution license (The Author(s) 2020).

Note: This patient-friendly article is based on peer-reviewed research published in a reputable medical journal. It is intended for educational purposes and does not constitute medical advice. Always consult a qualified eye care professional for guidance on your child's specific needs.