Laser myopia and amblyopia treatment equipment faces the strictest supervision

As summer approaches, myopia prevention and control treatment has become a hot topic of concern for parents.

According to the regulations of the National Medical Products Administration, starting from July 1, 2024, laser myopia and amblyopia treatment equipment products that have not obtained a Class III medical device registration certificate shall not be produced or sold.

The reporter learned that currently, no laser myopia and amblyopia treatment device has obtained a Class III medical device registration certificate, and there is no scientific evidence to support its efficacy.

Some laser myopia and amblyopia treatment devices are commonly referred to as "feeding devices" in the market.

As a second-class medical device regulatory product, the "feeding device" has been on the market in China for more than ten years, but its effectiveness and safety have always been controversial.

The "feeding device" is a type of semiconductor laser.

The principle of the "feeding device" is to shine light into the eyes in a specific way, effectively supplementing the illumination time of adolescent eyes in a short period of time.

Some studies suggest that the use of a "feeding device" may improve retinal blood circulation, promote dopamine secretion in the retina, thicken the choroid and enhance the elasticity of scleral fibers, thereby inhibiting the occurrence and development of myopia.

In 2008, Aierxing Medical Technology Co., Ltd.'s "Feeding Device" became the earliest product to be launched, and many domestic manufacturers also produced it.

The average price of a "feeding device" is around 5000 yuan, and some portable instruments even sell for over 10000 yuan.

Due to the promotion of its effectiveness in preventing and controlling myopia, many parents want to use it for their children.

Many businesses are competing to produce, and there are also some chaos in the "feeding device" market, such as exaggerating the efficacy of laser myopia and amblyopia treatment devices, non-laser myopia and amblyopia treatment devices claiming to be able to treat myopia under the "laser" brand, and some "three-no" products (no formal manufacturer, no approval number, no quality guarantee).

The most important aspect of medical device products is their safety and effectiveness, and the effectiveness and safety of the "feeding device" have been controversial since its launch.

According to the "Expert Consensus on Repeated Low Intensity Red Light Irradiation Assisted Treatment of Myopia in Children and Adolescents (2022)" published in the Chinese Journal of Ophthalmology, research and application of Repeated Low Intensity Red Light (RLRL) irradiation assisted treatment of myopia in children and adolescents have been carried out in many parts of China.

Preliminary clinical research results show that RLRL eye irradiation can inhibit the rapid growth of myopia in children and adolescents.

However, due to the lack of relevant unified standards, non-standard applications occur from time to time, which also increases the potential risk of adverse reactions.

Sheng Xunlun, a member of the Ophthalmology Branch of the Chinese Medical Association, said that the "feeding device" cannot reduce the degree; if the usage time is not controlled properly, it can also cause damage to the macula of the fundus.

Zhang Yu, Deputy Chief Physician of the Eye Health Department at Gansu Maternal and Child Health Hospital, said that the commonly seen "feeding device" in the market uses red light instead of natural light to increase choroidal blood flow and prevent excessive axial growth.

However, the effectiveness and safety of long-term repeated low intensity red light irradiation still need further research.

According to reports, a 12-year-old girl in Hunan used an Aierxing "feeding device" laser radiation to treat myopia, but a few months later, she caused retinal macular light damage.

Therefore, on June 30th last year, the National Medical Products Administration issued a notice to classify laser myopia and amblyopia treatment equipment as a third-category medical device for management.

Starting from July 1, 2024, products that have not obtained the registration certificate for Class III medical devices are not allowed to be produced or sold.

According to the degree of risk, medical devices are classified into three categories for management in China. The third category of medical devices adopts the strictest supervision.

Medical device registrants need to submit registration application materials to the National Medical Products Administration, including product technology and performance requirements, energy safety research, animal trial research, clinical evaluation data, etc.

In September 2023, the Medical Device Technology Evaluation Center of the National Medical Products Administration released the "Key Points for Technical Evaluation of Myopia/Amblyopia Laser Therapy Devices (Draft for Comments)".

The document points out that there is currently no scientific and rigorous evidence to support the mechanism of laser assisted treatment for amblyopia/myopia.

According to international and domestic laser usage principles, all laser products cannot be stared at or gazed at for a long time, and currently the relevant laser safety standards are mainly based on situations where adults are considered, without taking children's usage into account.

"Laser irradiation products are high-risk products in the treatment of myopia/amblyopia and require extreme caution. Prolonged gaze at the laser may induce radiation-induced cataracts, degeneration of retinal tertiary neurons and pigment epithelial cells, and light damage to the macular area. Once damage is caused, it is difficult to recover through other treatment methods," the document stated.

The inclusion of laser myopia and amblyopia treatment equipment in the third category of medical device management means that supervision is becoming stricter, and market chaos is expected to be rectified.

On July 1st, the reporter learned from the database of the Medical Device Technical Evaluation Center of the National Medical Products Administration that as of now, no myopia/amblyopia laser treatment device has obtained a Class III medical device license.

The Gansu Provincial Drug Administration reminds parents to be extra careful when choosing eye protection products for their children to avoid being deceived.

Eye patches are suitable for relieving mild eye fatigue and discomfort caused by excessive use of the eyes. Vision training equipment is suitable for the recovery training or relief of visual fatigue in adolescents with pseudomyopia.

These products are easily exaggerated as being able to treat myopia. There is no "miracle tool", "miracle medicine", or "miracle doctor" for preventing and controlling myopia.

Do not easily believe the claims or guarantees of efficacy made by merchants when promoting products or vision correction services, such as "best efficacy", "guaranteed treatment", or "cure". (Reporters Liang Jun, Ma Sha, Zeng Liangliang, intern Zhi Yueyan)

Source: Economic Reference Report