Why did England and France call off myopic surgery?

Category: Medical / Diseases >> Hospitals

Description of the problem:

I want to go to surgery to treat myopia.

But when I watched the "Health" program about this, it said that Europe, England, France and other countries have called off such surgeries, and the so-called experts did not say anything. Why would they call it off?

Ans:

It's because experts think the procedure may have implications for patients' long-term safety

Editor's note: The Sunday Times recently reported that "medical watchdogs are preventing the NHS from carrying out laser eye surgery because of concerns about patients' long-term safety. surgery." Our reporter interviewed experts on this issue in the hope that it will help medical staff and myopic patients to correctly recognize and understand laser eye surgery. However, it should be emphasized that, after all, this type of surgery has a relatively short history, its long-term effects and safety, there is still debate in the academic community, in particular, there is still a purely profit-making and abuse of the technology, therefore, the patient to be careful with the choice of doctors is the first.

Small information

The full name of laser eye surgery is "excimer laser refractive corneal surgery", including excimer laser refractive keratomileusis (PRK), excimer laser subepithelial keratomileusis (LASEK), and excimer laser in situ keratomileusis (LASIK).

①Foreign patients often come to Tongren Hospital to "go back to work"

The Refractive Surgery Department of the Eye Center of Peking Tongren Hospital, which was the first to carry out excimer laser corneal refractive surgery to correct nearsightedness, farsightedness, and astigmatism, has completed more than 10,000 refractive error correction surgeries each year. Zhou Yuehua, Director of Refractive Surgery Department of Peking Tongren Hospital Eye Center, believes that excimer laser corneal refractive surgery is the safest and most effective surgical method to correct myopia at present.

It is understood that the safety, reliability and effectiveness of the surgery has been confirmed in the United States and Japan's relevant medical institutions, excimer laser refractive keratectomy (PRK), excimer laser subepithelial keratomileusis (LASEK), in the United States, has been through the FDA three-phase clinical verification.

Director Zhou Yuehua said, in some European countries, the technical level of these surgeries and Tongren Hospital and other similar hospitals in China, compared to the gap, they are only equivalent to the level of some of our small and medium-sized hospitals. There are often patients from European countries who are unsuccessful in local surgeries and come to Tongren Hospital to ask for another surgery.

Specifically to the United Kingdom, Zhou Yuehua, director of the United Kingdom to carry out this type of surgery started relatively late, equivalent to the level of Tongren Hospital in the 1990s. British doctors are now doing PRK, which is what we did four or five years ago, the safety of this kind of surgery is not comparable to the surgery we are doing now.

Dr. Fan Zhengjun, PhD, of the Excimer Laser Center for Ophthalmology at the Naval General Hospital, spoke about his understanding of the safety of the procedure. He said that if there are no postoperative complications and no infections without regard to visual quality, it can be considered safe. If there are no significant complications after more than a decade, the long-term results of the surgery should generally be considered favorable.

Dr. Fan Zhengjun said, the United Kingdom called off eye laser surgery, nor is it as everyone understands, such surgery will no longer be carried out. Rather, it is due to some of the realities of British society, such as such surgery can not enter the NHS and so on.

② Failure rate can not be as high as 1 / 10

The Reference News reprinted this article also said that the failure rate of such eye surgery is 1 / 10. Talking about this issue, Dr. Fan Zhengjun said, the United States to carry out this type of surgery has been more than 20 years, from the year of the animal experiments to today's clinical surgery, the implementation of more and more hospitals, more and more mature surgery, but also being more The surgery is becoming more mature and is being accepted by more patients. If the failure rate of the surgery is as high as 1 in 10, as mentioned in the article, then the surgery should not have been performed in the first place.

Director Zhou Yuehua said that the safety and effectiveness of this type of surgery is certain, but the success rate of any surgery can not be 100%. Just like wearing contact lenses, wearing framed glasses, there is a danger, this danger leads to blindness will not be less than laser surgery. The infection problem with contact lenses is well known, and trauma caused by cracked lenses in framed glasses is a major cause of blindness. "I don't know what the basis is for the reported failure rate of 1 in 10, but happily the success rate of excimer laser surgery at Tongren Hospital is much higher than in the UK."

Dr. Fan Zhengjun said that the criteria for this type of surgery are different for everyone: patients with low myopia require that they be able to remove their glasses and that their naked eye vision be as good as their corrected vision before surgery. If the myopia is high, up to 1,000 degrees, 2,000 degrees, as long as the operation can remove heavy glasses, vision slightly worse, patients can also accept. For the surgeon, the first requirement is that the surgery is safe, meaning there are no complications, and then the purpose of the surgery is achieved. For example, if a patient with 800 degrees of myopia has a corrected visual acuity of 1.0 with eyeglasses before surgery, and the naked eye visual acuity is only 0.8 after surgery, the patient may not be satisfied. In fact, after the operation, as long as the addition of a very low degree of lens, visual acuity can easily reach 1.0 or even higher. The doctor, however, believes that this has achieved the purpose of the operation, can completely remove the glasses.

Dr. Fan Zhengjun frankly admitted that this type of surgery is only one of the methods of correcting refractive error, and as with wearing frames and contact lenses, it is not the fundamental method of treatment of myopia. Because there is no reliable cure for myopia, this method of vision correction can still be accepted by patients who do not want to wear glasses.

③ Ophthalmologist ≠ refractive surgery expert

Director Zhou Yuehua expressed concern that a large number of hospitals in China are now carrying out eye laser surgery without regard to conditions and level. He pointed out that the gap between the overall level of medical care in China is very large, and the good level can be said to be the world's advanced level, or even better than that of foreign countries, such as our refractive surgery, while the poor is much worse. He said that the success of this type of surgery, the key to the implementation of the operation depends on the person, because any machine itself will not do surgery.

Director Zhou repeatedly emphasized that medical treatment is not a commodity and should not be advertised in a big way, nor should it be hyped in the media. He believes that some celebrities are insiders and experts in their own fields of specialization, but when it comes to the medical field, it can be said that they know nothing, and even endorse products that are only third-rate products. Such advertisements are detrimental to the image of celebrities and mislead consumers, which he personally disapproves of. For example, in some advertisements, everyone claims to be an expert, how can this be? Ophthalmologists are not the same as refractive surgery experts, because you do not have specialized training in refractive surgery.

Dr. Fan Zhengjun of the Excimer Laser Center at the Naval General Hospital shares this view. He said that the operation itself is very simple, but the requirements of the doctor is very high, the choice of indications before the operation, the doctor is required to have a very deep, comprehensive ophthalmology medical background, to understand the refractive, cornea, as well as the fundus and other ophthalmology comprehensive knowledge. The surgeon performing the surgery should ideally be qualified as at least a senior attending physician.

④ The purpose of the surgery is not exactly "remove glasses"

The refractive surgery department of Tongren Hospital Eye Center has published a booklet for patients who want to have surgery, called "Do you want to remove glasses? The booklet is an in-depth introduction to the indications and contraindications of laser eye surgery, a comparison of various surgical procedures, as well as pre-operative preparation, intra-operative cooperation, post-operative attention and more than a dozen other items. One of the most important is how to prepare for surgery, including how to face the effect of surgery.

Zhou Yuehua, director of laser surgery, emphasized that the purpose of laser surgery is not entirely to remove glasses. He told reporters that their grasp of the indications is relatively strict, and not every patient who comes to the clinic for surgery, mainly depending on what the patient wants to achieve a purpose.

He explained to the reporter, eye laser surgery can not guarantee 100% patient satisfaction. For example, some people's corneas are thin, the effect of surgery is certainly not as good as a thicker cornea - like a 2-meter tall person to use 1 meter of cloth to make clothes, which is obviously unrealistic. However, if a person with a thinner cornea insists on having the surgery, it depends on the effect he requires. If he is highly myopic with a myopia of 2,000 degrees, which may affect the quality of life, aesthetics and self-confidence, he may be satisfied with just a guarantee of wearing a slightly thinner eyeglasses with a thickness of 500 degrees after the surgery. However, a patient with 600-degree myopia may demand that his glasses must be removed, and he must also ensure that his naked-eye vision is the same as his preoperative corrected vision. Therefore, doctors in the refractive surgery department of Tongren Hospital Eye Center have to fully communicate with patients before surgery to understand the psychology of each patient and see what kind of treatment he wants to achieve.

⑤ Experts call for: raise the threshold of the qualification of the surgery

The experts said in an interview with the reporter that the training of doctors and the management of hospitals should be strengthened. Cao Gang, who is working on the national excimer myopia laser treatment induction certificate assessment in Yanqing, Beijing, is a staff member of the Chinese Medical Association's Large Medical Equipment Continuing Education Department. He told the reporter on the phone that they organize such a training assessment once a year. This year, the number of applicants is higher than in previous years, there are more than 800 people. They provide: 3 years of ophthalmology clinical experience, with a physician's license to practice medicine, you can go to the local provincial and municipal medical association registration. If the technician qualification enrollment, as long as there is a year of clinical work experience.

What kind of hospital can carry out such surgery? Cao Gang said, around the requirements in this regard is not the same, but there must be a large medical equipment configuration license, the relevant departments to allow hospitals to import the appropriate equipment, hospitals should have a license to practice medicine. In Shanghai, the requirements are more stringent, the second A hospital, no large medical equipment configuration license does not allow the import of such equipment, while in Beijing and other places, the threshold is relatively low. Now, there are about 1,500 hospitals in the country with equipment for this type of surgery.

Cao Gang said, now the most terrible is that some unscrupulous traders, buy the domestic large hospitals or foreign medical institutions out of the equipment, repair and packaging, and then sold to the local small hospitals. He said, for example, some vendors spend 200,000 yuan to buy obsolete equipment, maintenance costs 500,000 yuan, they went so far as to sell the price of 2 million yuan to the hospital. Some small hospitals can not afford to buy, they will also take the instrument as an investment, surgery profit sharing and other cooperative ways to sell. In this way, it is difficult to guarantee the safety and success of the operation.

Zhou Yuehua, director of the Ministry of Health, is a member of the national large-scale medical equipment excimer laser induction training expert group. He said that every year there are many doctors who come to Tongren Hospital for further training and learning refractive surgery, and experts from Tongren Hospital also go to various places to guide the surgery. He emphasized that the training must be rigorous, and not long ago two Korean doctors tried to qualify and failed their exams. Director Zhou called for the key is *** functional departments to formulate relevant policies in a timely manner to raise the threshold of qualifications for the implementation of surgery, at the same time, to strengthen the industry self-discipline.

UK calls off eye laser surgery (news link)

According to "Reference News" reprinted from the British "Sunday Times" reported: due to concerns about the long-term safety of patients, the British *** medical watchdog is preventing the National Health Service (NHS) from carrying out eye laser surgery.

A year-long evaluation of laser eye surgery by the National Institute for Diagnostic and Standardized Medicine concluded that the "available evidence" on the safety of the procedure was insufficient to support its rollout on the NHS.

At least 100,000 people in the UK spend between £2,000 and £3,000 a year on laser eye surgery to correct nearsightedness, lured by the lure of "getting rid of their glasses". A number of companies have promoted their eye surgery with extensive publicity about its effectiveness and safety.

But a draft report from the National Institute for Diagnostic and Standardized Care said, "There are concerns about the long-term safety of the procedure, and the available evidence is insufficient to support the performance of this type of surgery without specific consent (from the NHS)."

The report said that while there is evidence that laser surgery can help people with mild myopia improve their vision, there is no conclusive evidence to support the safety of the procedure as claimed by many companies.

The institute noted that because glasses can safely correct myopia, "other treatments must be absolutely safe to be appropriate."

Last year, the journal Ophthalmology said that the failure rate for such eye surgery was 1 in 10, not 1 in 1,000 as most advertisements claim.

Health Times (December 16, 2004, page 3)