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 Most people think that the British media report on this matter is "one-sided" and "outdated reference", which exaggerates the problems existing in LASIK surgery.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, was highly nearsighted 1000 degrees. At one time, she was forced to leave her glasses that looked 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 65,438+. 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.