Britain, the United States are arguing about the safety of laser vision correction surgery

The laser vision correction surgery (LASIK surgery) since the 90s of last century began to spread to many countries in the world from Europe and the United States, has regained clear and bright vision for many myopia patients around the world. However, there have been controversies surrounding the safety and side effects of LASIK surgery. Recently, Cai Ruifang, an adjunct professor of ophthalmology at Taipei Medical University who first introduced the surgery in Taiwan, suddenly announced that he will not perform this operation in the future. He said that after long-term observations, many patients who underwent surgery in the past had their visual acuity decreased after more than a decade, and the analysis may be related to inflammation of the corneal flap after surgery.

In Europe and the United States, the industry has long disputed the pros and cons of LASIK surgery. Because of the relatively new technology used and the lack of long-term follow-up studies, the long-term efficacy and safety of the operation are lacking. Multinational medical regulatory agencies have clearly stipulated that patients must fully understand the risks that may exist before surgery.

- Topic text: Wang Xiyi

United States

700,000 people per year

Laser surgery

In the early 1990s, the United States Food and Drug Administration (FDA) began reviewing LASIK devices.

In 1995, the FDA approved the first laser vision correction surgical system. By 1998, the FDA approved the LASIK laser therapeutic apparatus for mass production.

With the gradual decline in prices (thousands of dollars from the beginning of surgery for each eye down to more than a thousand dollars), a large number of LASIK surgical treatment center began operations, a large number of people enthusiastically accept surgery.

In the United States, LASIK surgery has become almost a financial "gold mine."

As of 2008, 12 million people in the United States have undergone LASIK surgery. The price of each eye ranges from 1,500 to 2,000 U.S. dollars.

Today, an average of 700,000 people in the United States receive LASIK every year.

dispute:

Is there any sequelae?

Due to the short history of LASIK surgery, there is no international long-term follow-up study report on this technology and evaluation of long-term efficacy after surgery. Some medical professionals are concerned that although many people are undergoing LASIK surgery, the data on complications caused by surgery are seriously insufficient, which leads to a lack of understanding of the risks of LASIK surgery.

Critics: Many patients have dry eye, dizziness and other side effects after surgery

Dr. Maurice Wexler was the head of the FDA's diagnostic and surgical equipment department from 1996 to 2000, and the LASIK surgical equipment was approved by him for use. Since last year, Dr. Wexler began to admit that the FDA's standards are not strict enough, and LASIK surgery may present a serious safety risk.

Statistics show that between 1998 and 2006, the FDA received 140 complaints about laser vision correction surgery. Since 2008, more and more patients have been dissatisfied with the results after receiving LASIK. Many even find Dr. Wexler’s complaints directly. For this reason, the FDA has to re-evaluate the long-term effects of LASIK surgery.

After investigation, many patients suffer from severe sequelae such as dry eye, dizziness, photosensitivity, night blindness, ghosting, and dilated cornea after undergoing LASIK.

Dr. Wexler believes that the complications caused by LASIK surgery "have become a major public health problem."

In an interview last September, Wexler said in an interview that “half of the patients undergoing LASIK have sequelae.” This statement was refuted by a well-known US LASIK surgical committee member and found that there was no scientific evidence.

In the United Kingdom, in 2004, the National Institute of Excellence Clinical Research (NICE), an independent medical regulator, stated that LASIK is effective for people with moderate or mild myopia, but currently there is very little evidence that this procedure is suitable for a wide range of Application and long-term safety.

Supporters: The proportion of long-term sequelae does not exceed 0.1%

NICE's survey found that patients with moderate or mild myopia have normal visual acuity of 63% to 79% after receiving LASIK surgery, but only 26% to 36% of patients have deep myopia or hyperopia.

Prof. NICE professor Bruce Campbell said that myopia can be treated with the risk-free method of wearing glasses. The potential risk of any surgery is worthy of attention.

However, Christopher Neve, chairman of the British Eye Laser Surgery Association, retorted: “From the year 1990 to 2004, approximately 280,000 people in the UK received LASIK surgery and it is estimated that the proportion of long-term sequelae does not exceed 0.1%.”

Supervision

Surgery risk

Preoperative must understand

The United States and the United Kingdom impose strict requirements on LASIK surgery.

American law states that "only doctors trained in laser correction surgery can perform such surgery if they have experience in medical management and corneal surgery."

The American Vision Correction Board recommends that patients be fully examined before surgery, understand the benefits and risks of surgery, understand the postoperative recovery process, and be prepared physically and psychologically.

In 2005, the British Parliament held a hearing on the safety of LASIK surgery. Experts at the meeting called for the strengthening of the supervision of eye clinics implementing LASIK surgery. It is proposed that the supervision be directly under the responsibility of the British Department of Health.

The British Consumers Association also recommends that patients should ask whether the doctor who performed the surgery before surgery is a specialist who is registered with the Comprehensive Medical Committee, whether he has received formal training, and has extensive experience in refractive surgery.

Glossary

Laser vision correction

Laser vision correction, or LASIK (laser-assisted in situ keratomileusis), is an operation that changes the curvature of the cornea through a laser to improve vision.

LASIK was performed by an ophthalmologist and was considered to be more suitable for general patients than other similar surgeries. The recovery time required for LASIK is shorter, and the patient feels less pain. It can correct vision problems such as nearsightedness, farsightedness, and astigmatism. It can make the patient's vision almost completely normal, and was considered to be nearly perfect. Author: Wang Xiyi

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