It's because experts believe the procedure may have implications for the long-term safety of patients
Editor's note: Reference News recently reprinted a report from the UK's Sunday Times stating that "Government healthcare watchdogs are blocking the NHS from carrying out laser eye surgery because of concerns about the long-term safety of patients ". Our reporter interviewed experts on this issue in the hope that it will help medical staff and myopic patients to correctly recognize and understand eye laser surgery. However, it should be emphasized that this type of surgery, after all, to carry out a relatively short history of its long-term effects and safety, the academic community, there is still debate, in particular, there is still 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 keratectomy", including excimer laser refractive keratectomy (PRK), excimer laser subepithelial keratomileusis (LASEK) and excimer laser in situ keratomileusis (LASIK).
①Foreign patients often come to Tongren Hospital to return to work
The Refractive Surgery Department of Peking Tongren Hospital Eye Center, which was the first to carry out excimer laser refractive surgery to correct nearsightedness, farsightedness and astigmatism in China, has completed more than 10,000 refractive surgeries annually. According to Zhou Yuehua, director of the refractive surgery department of Peking Tongren Hospital Eye Center, 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 Phase III clinical verification.
Director Zhou Yuehua said, in some European countries, the technical level of such surgeries and Tongren Hospital and other similar hospitals in China, there is still a gap, they are only equivalent to the level of some of China's small and medium-sized hospitals. There are often patients from European countries who come to Tongren Hospital and ask for another operation because their local operation is not successful.
Specifically in the UK, Director Zhou Yuehua said that the UK started this type of surgery relatively late, equivalent to the level of Tongren Hospital in the 1990s. The PRK that British doctors are doing now is what we did four or five years ago, and the safety of this type of surgery can't be compared with what we are doing now.
Dr. Fan Zhengjun, PhD, of the Excimer Laser Center for Ophthalmology at the Naval General Hospital, talked about his understanding of the safety of the procedure. He said that if there are no complications or infections after the surgery without considering the quality of vision, 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 that the UK's call for a halt to eye laser surgery is not, as is commonly understood, that such surgeries will no longer be performed. Rather, it was due to some practicalities of British society, such as the inability of such surgery to enter the NHS.
②Failure rate is not likely to be as high as 1/10
The article, reprinted in the Reference News, also said that the failure rate of this type of eye surgery is 1/10. Speaking of this issue, Dr. Fan Zhengjun said that the United States to carry out this type of surgery has been more than 20 years, from the year of the animal testing to today's clinical surgery, the hospitals are more and more mature surgery is more and more mature, and is also being accepted by more patients. 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 never have been performed in the first place.
Director Zhou Yuehua said the safety and efficacy of this type of surgery is certain, but the success rate of any surgery cannot be 100 percent. Just like wearing contact lenses, wearing framed glasses, there is a danger, and 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 the basis for the reported failure rate of 1 in 10, but it is encouraging to note that the success rate of excimer laser surgery at Tongren Hospital is much higher than in the UK."
Dr. Fan Zhengjun said that everyone has different standards for this type of surgery: 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, on the other hand, believes that this has achieved the purpose of the surgery and 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 like wearing frames and contact lenses, it is not the fundamental method of treating 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.
③Ophthalmologist ≠ Refractive Surgery Specialist
Director Zhou Yuehua expressed his concern that a large number of hospitals in China are now carrying out eye laser surgery without regard to conditions and standards. He pointed out that the gap between the overall level of medical care in China is very large, the good level can be said to be the world's advanced level, or even better than the foreign ones, such as our refractive surgery, while the poor ones are much worse. He said the success of such surgeries depends critically on the person who performs the surgery, because any machine itself will not do the 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 up by the media. He argued 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. 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? An ophthalmologist is not the same as a refractive surgery specialist because you don't 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 doctor's requirements are 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.
④The purpose of the surgery is not exactly to "remove glasses"
The refractive surgery department of Tongren Hospital's eye center has produced a pamphlet called "Do You Want to Remove Your 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 the patient for the surgery, including how to face the effect of the surgery.
Director Zhou Yuehua 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 will have to undergo the surgery, mainly depending on what the patient wants to achieve a purpose.
He explained to the reporter that eye laser surgery can not guarantee 100 percent 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.
⑤Experts call for: raising the threshold of qualification for surgery
Experts have said in interviews with reporters 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. For technician qualification enrollment, one year of clinical experience is sufficient.
What kind of hospitals can carry out such surgeries? Cao Gang said that the requirements in this regard are different everywhere, 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, about 1,500 hospitals nationwide have equipment for this type of surgery.
Cao Gang said the scariest thing now is that some unscrupulous traders buy equipment that has been phased out by large domestic hospitals or foreign medical institutions, repair and package it, and then sell it to small local hospitals. He said, for example, some vendors spend 200,000 yuan to buy obsolete equipment, maintenance cost 500,000 yuan, they went so far as to sell to the hospital at 2 million yuan. 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 rate of surgery.
Director Zhou Yuehua is a member of the Ministry of Health's national large-scale medical equipment excimer laser induction training expert group. He said that many doctors come to Tongren Hospital every year for further training and refractive surgery, and experts from Tongren Hospital also travel to various places to guide the surgery. He emphasized that the training must be rigorous. Not long ago, two Korean doctors tried to qualify and failed their exams. Director Zhou called for the key is the government functionaries to formulate relevant policies in a timely manner to raise the threshold of qualification to perform the surgery, and at the same time, to strengthen the industry's self-regulation.
Britain calls off eye laser surgery (news link)
According to a report by the Sunday Times, which was reprinted in Reference News: the British government's medical watchdog is preventing the National Health Service (NHS) from performing eye laser surgery because of concerns about the long-term safety of patients.
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 been heavily advertising the effectiveness and safety of their eye surgery in order to market it.
But a draft report by 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 was evidence that laser surgery could help people with mild myopia improve their vision, there was no conclusive evidence that could prove 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 suitable for use."
Last year, the journal Ophthalmology said the failure rate for such eye surgeries was 1 in 10, not 1 in 1,000 as most advertisements claim.