Red Light Therapy for Myopia in Children: Safety Concerns and What the Latest Research Reveals

Red light therapy is gaining global attention as a non‑surgical intervention to slow the progression of myopia in children. This approach, which uses specific wavelengths of red light in repeated low‑level therapy sessions, has shown promising results in slowing myopia progression in clinical studies, especially in Asia. However, there is growing concern about whether the devices on the market are truly safe for young eyes. A new laboratory evaluation published in JAMA Ophthalmology examines the safety of four commercially available red light therapy devices for myopia and raises important questions for clinicians, parents, and regulators. This blog explores the latest findings, explains what they mean for device safety, and offers balanced context for families considering this therapy. Source: JAMA Ophthalmology (online February 5, 2026, doi:10.1001/jamaophthalmol.2025.5660).

Why Red Light Therapy Is Being Used for Myopia
Myopia, or nearsightedness, is a condition in which the eye grows too long from front to back, causing distant objects to appear blurry. In recent years, repeated low‑level red light therapy has been promoted as a way to slow this progression in children. Some clinical trials, especially in East Asia, have reported reductions in the rate of myopia progression of up to 60–75 percent over one year with regular use. Mechanisms under investigation include changes in choroidal thickness and blood flow. Based on these promising clinical outcomes, multiple red light therapy devices have entered the market and gained regulatory approval in various countries.

Despite promising results, questions remain about how these devices work, where in the eye the effects occur, and, most importantly, whether they are safe for repeated use in growing children’s eyes.

The Research: What Was Studied
In a recent laboratory evaluation, researchers tested four commercially available red light therapy instruments to determine how much light they emit and whether they meet established safety standards. The study used American National Standards Institute (ANSI) guidelines for laser and eye safety to evaluate each device. ANSI sets limits on how much optical energy can safely enter the eye before it poses a risk of injury. These limits are defined for different types of light sources and exposure durations. The devices examined were:

• Sky‑n1201 – A laser‑based point source device sold for myopia therapy.
• Future Vision – Another laser‑based point source instrument.
• EyeRising – A widely used semiconductor laser device.
• AirDoc – An LED (light‑emitting diode)‑based instrument with a diffuse light source.

Laboratory measurements were made using precision instruments to quantify radiometric power and calculate estimated retinal irradiance for different pupil diameters. The study then compared the time each device would take to reach safety limits defined by ANSI.

Key Safety Standards Used in the Evaluation
ANSI defines safety groups and classifications for optical instruments:

• Group 1 Safety Limits: Devices that do not exceed maximum permissible exposure (MPE) thresholds within normal viewing or treatment durations.
• Laser Classifications: Ranging from Class 1 (safe under all conditions of normal use) to higher classes that carry greater risk.

These standards are used worldwide to assess the risk of retinal injury from light exposure.

What the Results Showed
The study found important differences between the devices:

• EyeRising and Sky‑n1201: Both laser‑based point source devices reached safety limits in a fraction of the recommended treatment time. For example, EyeRising exceeded the ANSI group 1 safety limit in just 1.4 seconds for a 7‑mm pupil diameter, far below the typical 180‑second treatment session. Sky‑n1201 reached safety thresholds in 2.8 seconds under the same conditions. These findings indicate that these devices emit coherent laser light at intensities that could exceed safety guidelines during normal therapy use. Under ANSI standards, EyeRising and Sky‑n1201 were classified as Class 2M laser devices, meaning they pose a potential hazard if used as recommended without strict controls.

• Future Vision: This point source device reached safety limits only after very long exposures (around 253 seconds or more). While still producing a laser beam, it remained within ANSI Class 1 limits for typical exposures, indicating a lower risk compared to the other lasers tested.

• AirDoc: As an LED‑based instrument with diffuse light, AirDoc produced irradiance levels that did not approach ANSI safety limits for standard treatment durations. Its time to reach group 1 limits was extremely long (over 22,000 seconds), and it was classified as a group 1 ophthalmic instrument, considered safe to view for extended periods. However, this device has not yet been studied in clinical trials for myopia control, so its effectiveness is unknown.

Why These Findings Matter
These results highlight several issues related to the safety of red light therapy devices for myopia:

1. Laser‑Based Devices May Exceed Safety Limits: Devices that produce coherent laser light could expose the retina to irradiance levels above accepted safety thresholds in much shorter time frames than the recommended treatment duration. This increases the theoretical risk of retinal injury.
2. Retinal Injury Has Been Reported in Clinical Use: There have been case reports of retinal structural damage and changes in photoreceptor density following repeated red laser therapy, particularly in children using the EyeRising device. Such findings illustrate that high‑resolution imaging and long‑term follow‑up studies are crucial for detecting subtle or progressive retinal effects that standard clinical exams may miss.
3. Regulatory Shifts Reflect Safety Concerns: In China, where red laser therapy for myopia was first widely adopted, regulators reclassified repeated laser‑based red light devices as high‑risk medical devices (Class III), requiring more rigorous testing before use. Red light therapy was also excluded from the latest national guidelines for myopia control.
4. LED Devices May Offer a Safer Profile: Diffuse LED‑based instruments like AirDoc did not exceed ANSI safety thresholds in laboratory conditions. While this suggests a safer optical profile, their clinical effectiveness has not yet been established.

Clinical and Public Health Implications
Families and clinicians considering red light therapy for myopia should be aware of the complex balance between potential benefits and risks. While the treatment has shown promise in slowing myopia progression, safety cannot be assumed based on clinical outcomes alone. Laboratory evaluations using established standards like ANSI Z136.1 and ANSI Z80.36 provide valuable insight into the physical properties of these devices and the potential for retinal exposure beyond safe limits.

It is also important to note that current safety classifications do not differentiate between adults and children. Because children’s eyes are still developing and may be more sensitive to optical energy, safety considerations should be even more cautious in pediatric populations. Long‑term follow‑up, advanced imaging, and functional testing are essential to detect subtle changes that might not be immediately visible through standard eye exams.

Limitations of the Research
This study was conducted in a controlled laboratory environment and does not directly measure how human eyes respond in real‑world clinical settings. Factors such as eye movement, pupil dynamics, ocular media absorption, and retinal adaptation were not part of the evaluation. Furthermore, only four devices were tested, and other red light therapy products may exist with different safety profiles.

Disclaimer
This blog post is for informational purposes only and does not constitute medical advice. If you are considering red light therapy for myopia management, discuss the potential risks and benefits with a qualified eye care professional. Device safety and effectiveness can vary, and individual treatment decisions should be made based on professional guidance and current scientific evidence.

Conclusion
Red light therapy represents a novel and potentially impactful approach to slowing myopia progression in children. However, recent laboratory research raises significant safety concerns for some laser‑based devices on the market. While LED‑based instruments may offer a safer alternative, their efficacy has not been established. Before red light therapy becomes widely recommended for pediatric use, independent safety validation, long‑term clinical studies, and robust regulatory oversight are essential. Families and clinicians must weigh potential vision benefits against the possibility of retinal injury and choose interventions grounded in both safety and effectiveness.

Source: Ostrin LA, Schill AW. Safety Evaluation of 4 Red Light Therapy Devices for Myopia. JAMA Ophthalmol. Published online February 5, 2026.