Since the end of last year, the domestic media have paid unprecedented attention to the surgical treatment of myopia, which was caused by the report entitled "Ophthalmic surgery is too dangerous for the national medical service system" published by the British Sunday Times on February 6 last year. According to the report, in view of the recent problems such as decreased vision, weakened corneal strength, infection and retinal detachment in some patients with myopia or hyperopia, their safety is worrying, and the medical supervision department of the British government has blocked excimer LASIK surgery in the national medical service system. The report also pointed out: "The failure rate of eye laser surgery is about 10%."
As soon as this article came out, it caused great repercussions in the international arena. Ophthalmologists and medical institutions in various countries have expressed their opinions. Most people think that the British media report on this matter is "one-sided" and "outdated reference", which exaggerates the problems existing in LASIK surgery. Nevertheless, after the report was reprinted by the domestic media, millions of people who received excimer laser myopia treatment in China were still "uneasy", leaving people who were considering this kind of surgical treatment at a loss.
A company's mistake caused Britain's "national system" to say "no"
According to authoritative data, the total success rate of laser surgery in China is over 95%
It is understood that the medical supervision department of the British government has prevented excimer laser surgery in the national medical service system. The main reason is that after a British pharmaceutical company named Boots performed excimer laser surgery for myopia patients, the patients suffered from blurred vision and visual impairment. The company was forced to close nine excimer laser centers.
Experts all over the world believe that the problem of only one company cannot represent the level and real situation of excimer laser surgery in the world. The failure rate of 10% reported in the Sunday Times was quoted from the journal Ophthalmology. Literally, it refers to the failure rate of eye surgery, not just excimer laser surgery. The executive director of the American Refractive Surgery Quality Assurance Committee said: "We are an organization that represents the interests of patients. If the failure rate of LASIK is really that high, we will point it out first. " According to statistics, in 2004, about 6.5438+0.2 million people in the United States underwent LASIK surgery, and the incidence of complications was about 3%, among which the serious complications requiring surgical treatment were below 0.5%.
Since 1990, the NHS has been providing LASIK surgery for those patients who wear glasses or contact lenses to correct their poor eyesight, with about 800 people per year, accounting for only 0.8% of LASIK surgery in the UK every year. Since NHS provides free medical care, it is also in line with international practice to say "no" to LASIK surgery. But this does not mean that excimer laser surgery has been banned in Britain, so some domestic media's statement that "Britain stops excimer laser surgery" is not accurate.
Professor Zhao Jialiang, the only China academician of the International Ophthalmology Association (AOI), chairman of the Ophthalmology Branch of the Chinese Medical Association and director of the Department of Ophthalmology of Peking Union Medical College Hospital, told the reporter that the total success rate of excimer laser surgery in correcting myopia in China has reached over 95%. From June 5438 to March 0993, Peking Union Medical College Hospital took the lead in developing excimer laser myopia treatment in China, and has accumulated tens of thousands of surgical experiences so far.
From June 5438, 2004 to February 2004, the International Journal of Ophthalmology published a paper entitled "Review of 26743 Refractive Corneal Surgery" by Dr. Mars of Peking Union Medical College Ophthalmology. This paper systematically reviewed and summarized 26743 patients (44580 eyes) who underwent excimer laser surgery in Concord Ophthalmology from May 6, 2003 to May 2003. On the basis of strictly tracking and keeping complete data, they used mathematical models to establish a database for scientific statistical analysis. The results show that excimer laser refractive corneal surgery is safe and effective, and 98.7% patients have achieved good vision correction.
Experts point out that there is no absolutely safe operation in the world.
All kinds of myopia operations should be carried out cautiously on the basis of dialectical analysis.
Since April and May this year, news from Shanghai, Beijing and other places shows that there has been a "rework tide" in myopia surgery. The ophthalmology department of some comprehensive 3A hospitals receives nearly 100 patients who require reoperation because of failed surgery every month. It is reported that nearly 70% of the patients who asked for "rework" underwent the earliest invasive surgery for myopia-radial keratotomy (rk) more than ten years ago. RK surgery has been abandoned by most medical institutions because of its high risk of complications.
RK surgery was once "popular" in southern cities. According to Professor Wu, deputy director of the Department of Ophthalmology, Southern Hospital of Southern Medical University, RK surgery was invented by experts from the former Soviet Union in the 1940s. The former Soviet Union and Japan did more, and China in the late 1980s and early 1990s. RK surgery is based on the shallow understanding of the anatomical structure and physiological function of human cornea in the medical field. The doctor needs to cut the cornea radially around the cornea by himself. "The impact of this operation on the human eye can be said to be catastrophic." Wu Dui said: Because the cornea is cut too deeply in RK surgery, it is easy to cause corneal perforation and infection during surgery, and the eyeball of the patient may be "torn" by external force after surgery. What is particularly frightening is the "innovation" of Japanese doctors in RK surgery. They do not operate from the corneal epithelial surface, but "move the knife" from the corneal endothelial surface, which will never regenerate, causing many patients to pay a heavy price for being blind forever. Fortunately, China followed the method of the former Soviet Union, and RK surgery has basically been replaced by excimer laser surgery.
Experts pointed out that with the continuous updating of surgical equipment and examination instruments, and the continuous improvement of surgical methods and skills, the safety of excimer laser surgery has been greatly improved compared with the "RK era".
Excimer laser is an invisible ultraviolet beam produced by mixing argon fluoride, which belongs to cold laser. This kind of light beam can split several layers of corneal molecular bonds and vaporize the cell tissue, but it has no effect on the surrounding tissue. Excimer laser treatment of myopia is to use this efficient beam to change the curvature of the corneal surface, thereby reducing the refractive power of the cornea and achieving the purpose of accurately correcting myopia.
At present, a new operation called "individualized cutting" has begun to appear, that is, "LASIK surgery guided by wavefront aberration". By connecting the analysis system of the eye aberrometer with the excimer laser treatment system, the doctor can completely correct the aberration of the human eye, so that the naked eye vision after operation may approach or reach the limit vision of the human eye 3.0, which represents the latest development trend of myopia laser surgery.
Professor Zhao Jialiang pointed out that there is no absolutely safe operation in the world. Excimer laser surgery has a history of 10 years since its birth. At present, this kind of surgery is widely carried out all over the world, and thousands of people have recovered their clear vision. This alone has fully explained the advantages of excimer laser in the treatment of myopia. At the same time, excimer laser surgery, like any other surgery, has certain risks. More importantly, because the operation is performed on the normal cornea, it is the icing on the cake and unnecessary. Therefore, medical institutions should dialectically analyze all kinds of myopia operations and carry them out cautiously according to their own conditions. Before operation, patients should also have a more comprehensive understanding of the risks of such operations. Only by carefully selecting hospitals and doctors can we ensure safety.
The core conclusion of Professor Mars's "Analysis of Long-term Clinical Effect of Refractive Surgery" is that different surgical methods have their indications, LASIK surgery is suitable for most patients, low myopia can choose multiple surgical methods, and patients with thin cornea can choose LASIK; Perfect preoperative examination, skilled surgical skills, strict aseptic operation and reasonable postoperative medication are important means to avoid serious complications.
The market is huge, and there are 600 excimer laser therapeutic devices running in China.
The Ministry of Health issued more than 65,438+0,000 "employment certificates".
Millie, a 33-year-old employee of a company in Beijing, is highly nearsighted 1000 degrees. At one time, she was forced to leave glasses that were better than the bottom of a beer bottle and could not move. This spring, she made up her mind to bid farewell to the "bottom of beer bottle" that followed her for decades, so she went to the ophthalmology department of Peking Union Medical College Hospital for LASIK surgery. The moment she took off the blindfold, she was shocked: the black eyebrows of the nurse opposite were so clear that even the fine lines on her head could be counted one by one! The sky outside the window is so blue and bright ... She grabbed her husband's neck excitedly and said "super cool", which made everyone in the room laugh.
At the relevant meeting held by the World Health Organization in 20001year, experts from various countries discussed the treatment of "ametropia" (including myopia, hyperopia and astigmatism), and everyone suggested that "correcting" ametropia "should be an important task in preventing blindness".
Professor Zhao Jialiang said that myopia is a major public health problem in China. 1998 under the unified arrangement of the world health organization, he and his colleagues went to the suburbs of Beijing to investigate the myopia prevalence rate of school-age children aged 5- 15. The results showed that boys and girls had almost no myopia at the age of 5, and the prevalence of myopia in girls increased after the age of 8, reaching 55% at the age of 15, while in boys it increased after the age of 10, reaching 65438+. According to the person in charge of Guangdong Optometry Association, the association recently completed an eight-year vision survey of 2.96 million students in Guangzhou. The results show that the prevalence of myopia in senior high school students, junior high school students and primary school students in Guangzhou is 80%, 60% and 30% respectively. What is even more worrying is that nearly 20% children in kindergartens have poor eyesight. Compared with three or five years ago, the growth rate of students' myopia rate exceeded 10% ... The extremely large myopia population has formed a market with great potential for myopia correction due to factors such as going to school, recruiting, and pursuing a higher quality of life like Millie.
According to the latest statistics, there are as many as 600 excimer laser therapy machines in operation in China. Hospitals in large and medium-sized cities, even county hospitals. In 2004, more than 500,000 patients underwent surgery, which exceeded the number of patients undergoing cataract surgery, and the resulting market competition was inevitably "white-hot". In order to attract patients, some small hospitals with weak technical strength, equipment (some even introduced foreign obsolete equipment) and unsatisfactory environment compete to lower prices, and some even "make money at a loss" at a price lower than the cost. If the price is low, the standard is bound to be low and the quality is low, not to mention the doctor's "hand tide" and the operation process is not standardized. For example, surgical instruments that should be used once, such as corneal blades, should be used after Zhang San's use, and conjunctival lavage fluid should be used by one person, but in a small hospital, a bottle of conjunctival lavage fluid needs four or five patients, and disinfection is not in place, which is very easy to be infected ... May 265438+
Many experts emphasize that excimer laser surgery is a complex system engineering. Only by relying on an experienced surgeon and an advanced laser surgical equipment, it is impossible to achieve the ideal surgical effect. Preoperative examination, surgical design, intraoperative operation, patient cooperation, postoperative medication, nursing and follow-up are all closely related to the surgical effect. Therefore, it is necessary to improve the entry threshold, standardize the operation and strengthen administrative supervision.
Mars is currently the head of excimer laser surgery in Cornology Group of China Ophthalmology Society, and a member of the national qualification examination expert group of large medical equipment users in the National Medical Examination Center of the Ministry of Health. According to her introduction, in order to strengthen the supervision of the access and use of large-scale medical equipment, including excimer laser machines, as early as 1998, the Ministry of Health entrusted the Chinese Medical Association to start implementing a national-level continuing medical education project called "pre-job training for users of large-scale medical equipment", and only those who passed the examination after training were awarded qualification certificates. So far, more than 1000 ophthalmologists with medical licenses have obtained the qualification to use excimer laser therapy machines. Training is held once a year. At first, less than 100 people signed up. Last year, nearly 600 people signed up. Mars said that on the one hand, it proves that excimer laser surgery is really "hot", on the other hand, it also shows that the standardized management of excimer laser surgery is getting more and more attention.
Myopia surgery cannot "cure" myopia.
Experts call for further strengthening advertising supervision.
Last year, at least 500,000 people in China underwent excimer myopia surgery. Does this mean that "there are 500,000 nearsighted people in China"? The expert's answer is no.
Professor Zhao Jialiang pointed out that all the methods for treating myopia at this stage belong to "symptomatic" treatment, not "causal" treatment, and excimer laser surgery can only "correct vision" but not "radically" myopia. Every patient who has undergone or will undergo excimer laser surgery should know that surgery can only make you take off your glasses, but it can't change the essence of your myopia. For a simple example, if the preoperative myopia is 1 0,000 degrees and the postoperative naked eye vision is 1.0, you don't need to wear glasses. Although it looks like a normal person on the surface, your intraocular structure and retina are still in the primitive state of high myopia. All possible complications of high myopia, such as glaucoma and retinal detachment, may occur. Don't neglect eye hygiene because you don't need to wear glasses.
In addition, excimer laser surgery is not suitable for everyone. Not suitable for the following patients:/kloc-nearsighted children under 0/8 years old (because their refractive system is underdeveloped); The degree of myopia is unstable, and there is still a trend of deepening year by year in recent years; Active eye diseases (such as inflammation, glaucoma, severe dry eye); The central thickness of cornea is less than 450 microns; Patients with other serious eye diseases (such as keratoconus) or autoimmune diseases, scar constitution and severe diabetes. In addition, excimer laser surgery is not the first choice to correct myopia if the myopia degree is above 1600 degrees.
"Visual quality is a higher-level concept than vision." Dr. Yu Zhiqiang from the Eye Excimer Laser Center of the Otolaryngology Hospital affiliated to Fudan University said. It requires not only normal vision above 1.0, but also clarity, comfort and stability. In addition to the positive diopter, it also involves aberration, contrast sensitivity, night vision, tear film stability and other factors. At present, excimer laser technology can only improve the naked eye vision, but not the visual quality. On the contrary, surgery may also lead to a decline in visual quality. For example, vision loss at night. In the early period after excimer laser surgery, some myopia patients with 300 degrees or above usually complain that their eyesight at night is not as good as that during the day, or that their eyesight drops in rainy days. In fact, this is a difficult problem that excimer laser surgery has not yet overcome. The main reason is that surgery reduces the sensitivity of visual contrast and increases the aberration of patients.
Understand the above truth, people can enhance their "immunity" to all kinds of exaggerated advertisements in society.
It is reported that due to different sources of equipment and other reasons, there is still a lack of national unified technical specifications and standards for excimer laser surgery. At the beginning of this year, led by Wenzhou Medical College, Peking Union Medical College Hospital, Guangzhou Zhongshan Eye Center, Eye, Otolaryngology Hospital affiliated to Fudan University and other medical units 10 participated in the national tenth five-year plan project "Improving the safety and effectiveness of refractive corneal surgery". This large-scale study will further explore the factors affecting visual quality; This paper discusses how to meet the requirements of clarity, comfort and durability in optometry under the principles of safety, effectiveness, accuracy, stability and minimal damage.
Many experts said in an interview with reporters that strengthening industry guidance is the most important and operable entry point for standardizing excimer laser surgery at this stage. Through academic exchanges, scientific and technological research and organization and coordination, we will come up with guiding opinions applicable to the whole country.
On may 2 1 ~ 22, the national high-level seminar on excimer laser surgery held in Beijing focused on the issue of "preoperative" and emphasized the word "strict". First, patients must be strictly selected to exclude autoimmune diseases, such as diabetes, high intraocular pressure, glaucoma, corneal inflammation and so on. The second is to strictly control the access of doctors. Even if they pass the training of the Ministry of Health (entrusted by the Chinese Medical Association) and pass the examination and get the post certificate, they may not be able to go to the operating table. Measures similar to the "annual inspection" of automobile drivers should be taken to strengthen the supervision and management of doctors who have been on duty. Mars said that the preoperative guidance or suggestions of excimer laser will be issued shortly after this meeting. Next, we will ask questions step by step during and after the operation.
The title is Divide and Rule.
Professor Zhao Jialiang revealed that the national norms and standards for excimer laser surgery will be expected to be introduced this year.
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At present, there are three kinds of excimer laser surgery in China-
Excimer laser in situ keratomileusis. First, a corneal flap was formed on the corneal surface with a microkeratome, then the intermediate corneal stroma was cut with excimer laser, and then the corneal flap was reset. This method preserves corneal epithelium and anterior elastic layer, so it is most in line with corneal anatomy and physiology. The patient's pain was mild and his vision recovered quickly (12 hours). The disadvantage is that he needs expensive and precise instruments and equipment, which requires high technical level of doctors and operating environment, and the operation cost is high.
LASEK: excimer laser keratomileusis. Use corneal epithelial trephine to cut out epithelial flap. After the epithelial flap is opened, it is ground in situ by excimer laser, so as to change the diopter of cornea and correct myopia astigmatism. Then the epithelial flap is reset, which avoids the risk of poor flap making during LASIK operation and is suitable for patients with moderate and low myopia with thin cornea. The disadvantage is slow vision recovery, occasional corneal subepithelial opacity, and glucocorticoid drip for more than two months after operation.
PRK: excimer laser photorefractive keratectomy. It uses the characteristics of excimer laser to directly cut the corneal optical zone. The operating equipment and operation are relatively simple and the cost is relatively low. However, the patient's postoperative eye pain was severe, lasting more than 10 days. Long-term drip of glucocorticoid after operation may lead to glucocorticoid-induced glaucoma. Therefore, this operation has gradually lost its market in China.
Several situations of postoperative service
1, patients with exophthalmos or atrophy of eyeball: patients with exophthalmos or depression caused by wearing glasses and myopia will have a great impact on their own image once they take off their glasses, so it is necessary to treat exophthalmos.
2. Patients with myopia or myopic astigmatism after surgery. Some myopia patients suffer from astigmatism or myopia after operation due to imperfect or incomplete operation, which seriously affects their vision. At this time, it is very necessary to choose conservative therapy. However, theoretical analysis shows that if it is difficult to achieve the ideal effect with conservative treatment, only regular astigmatism can be completely cured.
3. Suffering from myopia after operation. Some myopia patients have myopia after operation due to a large number of close-up eyes, and the degree is generally light, which is not suitable for further surgery. Conservative treatment has become the first choice.
4. Although, in theory, preoperative conservative treatment is the best choice for moderate and high myopia, it is very necessary to prevent myopia complications through conservative treatment for patients who have undergone surgery and have complications.
5. Suffering from hyperopia after operation. According to the theory of use and waste, this situation depends on self-adjustment, glasses fitting or re-operation, and the diopter of the eye is adjusted within a certain range.
Investigation on the adaptability of myopia surgery and its postoperative prevention and treatment
Myopia develops step by step, or the diopter of the human eye is constantly developing and changing, but this process is slow and difficult to be detected. Generally speaking, some people will be relatively stable for a long time, while others can't. Because of the great differences in major (or related work), living habits and eye habits, and the great differences in refractive status of eyes, some people's myopia will gradually develop, especially for those who use more eyes recently, the prevention and treatment of myopia is always a problem that needs attention.
Why is people's vision basically stable after they are twenty years old? First of all, before the age of 20, most of the respondents were primary and secondary school students or college students. This kind of people are easy to find out, and myopia is progressing rapidly because of the pressure of entering a higher school. However, after the age of 20, after graduating from middle school or university, the personnel are diverted and not so concentrated, so there is no accurate statistics. Secondly, after the age of 20, people's physical development has basically stopped or slowed down, and their height has reached the height of adults. The pressure of entering a higher school has disappeared or eased, and reading and writing have been able to keep a long distance, such as more than one foot. Even under the same study burden and time, the progress of myopia will slow down. Third, after the age of 20, the living environment is relatively certain, and the degree of myopia of most people is greatly reduced, so the problem of myopia is not important or disappears, so it is not concerned or paid less attention. But this is not always the case. According to a survey, even people over 35, such as typists, writers, painters and people who often surf the Internet and play computer games, will suffer from myopia or get worse because they often look at things at close range. Fourth, after the age of 20, people's growth and development are slow, and their eyes' adaptability and plasticity are reduced, so they remain relatively stable, so their eyesight remains relatively stable.
Therefore, even if the operation effect is ideal, don't think that everything will be fine after the operation. This idea is unrealistic. Regardless of the operation or not, we must do the following:
1) keeping the eye stable: the theory that the eyes will adapt according to environmental changes. Generally speaking, there is no need to prevent eye fatigue from affecting work, life or study. However, we should make appropriate adjustments, arrange our lives reasonably and take good care of the health of our eyes. It is necessary for patients who often surf the Internet to spend less time on the Internet and do more outdoor activities.
2) There is also a situation where there are too few near eyes and people who use too many far eyes will have presbyopia. If myopia is not enough to offset the natural resilience of the eyes, then eye fatigue and presbyopia are prone to occur at close range.
3) For people with high degree of surgery, because the eyeball structure of these people has not changed, myopia complications will further develop if a large number of eyes are used at close range. Therefore, in order to prevent the occurrence and development of complications, it is best to make eyes old, but it is best not to aggravate myopia.
It is also a common choice to see a doctor if there is a problem, but reasonable conditioning and usual prevention are very necessary. Eyes are your own before the game, and it is an eternal topic to care for your eyes and pay attention to their health. In this way, we need to discuss and deal with problems, and the countermeasures are:
1, preoperative service:
Theoretically, myopia of several hundred degrees or higher is best solved by non-surgical methods. However, considering the long treatment period and the patient's cooperation and patience, it is more appropriate to perform surgery after eye treatment and efforts to reduce refractive power, so there is no worries about surgery (assuming the operation effect is ideal).
2. Treatment of exophthalmos and severe myopia: The newly researched instrument can easily solve this problem, which should be the first consideration for patients undergoing surgery.
3. Undercorrection in myopia surgery: that is, the change of diopter during surgery is not in place, and there are still some myopia degrees. At this time, the treatment with instruments will have two effects: one is to treat myopia, and the other is to treat exophthalmos and beauty. Because the treatment of low myopia is not difficult, the non-surgical treatment effect of astigmatism caused by surgery is weak.
Why did Britain stop eye laser surgery?
According to the report of China Chinese Medicine News, the United Kingdom stopped eye laser surgery.
"According to overseas media reports, due to concerns about the long-term safety of patients, the British government medical regulatory authorities are preventing the National Health Service (NHS) from performing eye laser surgery.
The National Institute of Standardization of Diagnosis and Treatment conducted a one-year evaluation of eye laser surgery. The evaluation result shows that the "existing evidence" about the safety of this kind of surgery is not enough to support the promotion of this kind of surgery in the national medical service system.
Under the temptation of "taking off glasses", at least 654.38 million people in Britain spend 2-3,000 pounds on eye laser surgery every year to correct myopia. In order to promote their eye surgery, some companies have made a lot of publicity about its effect and safety.
However, a draft report of the National Institute of Standardized Diagnosis and Treatment said: "There are concerns about the long-term safety of the operation, and the existing evidence is not enough to support the operation without the special consent of the national medical service system."
The report said that although there is evidence that laser surgery can help people with mild myopia improve their vision, there is no conclusive evidence to prove the safety of surgery claimed by many companies.
The institute pointed out that because wearing glasses can safely correct myopia, "other treatment methods must be absolutely safe to be suitable for use."
Last year, the American Journal of Ophthalmology said that the failure rate of this kind of ophthalmic surgery was110, instead of1/000 as stated in most advertisements.
It can be seen from the above reports that "there are concerns about the long-term safety of the operation" and "the existing evidence is not enough to support the operation"-the final understanding is that the reason for stopping is not the operation itself, but the concern about possible problems after several years of operation. Because it is only in recent years that large-scale laser surgery for myopia has been carried out, the short-term effect of the surgery can be evaluated, but the long-term effect has not been confirmed, and it will take at least 30 years or even longer to prove whether the myopia surgery is successful. We haven't conducted such a long-term experiment. In other words, patients who have undergone laser surgery are experimenters. Therefore, we must be cautious about myopia surgery-
1, if you think that there is no myopia when the laser is swept away, it seems that this problem is simplified.
2. The so-called one thousandth is actually a problem with the operation itself. In fact, quite a few people have fatigue or presbyopia. Is this a surgical problem? According to Tongren Online, it seems that 25% people have similar problems.
3. Two, three or even longer presbyopia after the operation should also be the sequela of the operation (not successful), at least according to British standards.
It can be seen from this report that the highest goal of others is not to pursue the so-called economic interests, but to pursue the attitude of scientific truth and benefit human health.