From the end of last year to the present, there has been an unprecedented increase in the domestic media's attention to surgical treatment of myopia, due to a report published in the Sunday Times on Dec. 6 last year, titled "Eye Surgery Too Dangerous for the NHS". According to the report, the UK government's healthcare regulator has prevented excimer laser surgery from being performed on the NHS in light of concerns about the safety of excimer laser surgery, which has recently been associated with reduced visual acuity, corneal strength, infections, and retinal detachment in some patients treated for nearsightedness or farsightedness by "excimer laser in-situ keratomileusis" (LASIK). surgery on the NHS. The report also noted that "the failure rate for eye laser surgery is about 10 percent."
The article caused a great deal of international reaction. Ophthalmologists and medical institutions from all over the world have expressed their opinions, and the vast majority of them believe that the British media's report on this matter has the flaws of "generalization" and "citing outdated information", and has exaggerated the problems of LASIK surgery. Nevertheless, the report, reprinted in the domestic media, still made millions of people in China who have already received excimer laser myopia treatment "thump in their hearts", and left those who are considering such surgical treatments at a loss.
A company's mistake led to the British "national system" said "NO"
Authoritative data in China's total success rate of laser surgery reached more than 95%
It is understood that the British government's health care regulator prevented the NHS from carrying out excimer laser surgery. It is understood that the British government medical regulators prevented the NHS from carrying out excimer laser surgery, mainly because of a British pharmaceutical company called Boots in the implementation of excimer laser surgery for myopic patients, patients have blurred vision, vision impairment and other problems, the company was forced to close its subordinate nine excimer laser centers.
Experts in various countries have argued that the problems that occurred at just one company are not representative of the level and true state of excimer laser surgery worldwide. The 10 percent failure rate referred to in the Sunday Times article, quoted in the journal Ophthalmology, literally refers to the failure rate of eye surgery (eyesurgery), not just excimer laser surgery. The executive director of the American Board for Refractive Surgery Quality Assurance said, "We are an organization that represents the interests of our patients, and if the LASIK failure rate was really that high, we would be the first to point that out." According to statistics, about 1.2 million people in the United States underwent LASIK in 2004, with a complication rate of about 3 percent, including less than 0.5 percent of serious complications requiring surgical management.
Since 1990, the British NHS has been offering LASIK surgery to patients who wear frames or contact lenses to correct their unsatisfactory vision, with about 800 people per year, accounting for only 0.8% of the annual volume of LASIK surgeries in the United Kingdom. As the NHS provides free healthcare, it is in line with international practice to say "NO" to LASIK surgery. However, this does not mean that excimer laser surgery is banned in the United Kingdom, so some of the domestic media on the "United Kingdom called off excimer laser surgery" is not accurate.
The International Academy of Ophthalmology (AOI), the only Chinese academician, chairman of the Chinese Medical Association Ophthalmology Branch, Peking Union Medical College (PUMC) Hospital Director of Ophthalmology, Professor Zhao Jialiang, told the reporter that China's current application of excimer laser surgery to correct myopic patients' eyesight has reached more than 95% of the total success rate.
The PUMC Hospital was the first to carry out the excimer laser myopic treatment in March 1993, and has accumulated tens of thousands of cases of myopic surgery since then. In March 1993, Peking Union Medical College (PUMC) was the first hospital in China to carry out excimer laser myopia treatment.
In December 2004, the International Journal of Ophthalmology published a paper titled "A Review of Refractive Corneal Surgery 26743", authored by Dr. Ying Li of Peking Union Medical College (Peking Union Medical College) Ophthalmology Department and others. The article summarized in a systematic review 26743 patients (44,580 eyes) who underwent excimer laser surgery from May 1993 to May 2003 at the Department of Ophthalmology of Peking Union Medical College. On the basis of strict follow-up and retention of complete information, they applied mathematical models to establish a database for scientific statistical analysis. The results of the study showed that excimer laser refractive corneal surgery was safe and effective, and 98.7% of the patients obtained good vision correction.
Experts point out that there is no absolutely safe surgery in the world
All kinds of myopic surgery should be analyzed and carried out cautiously
Since April or May this year, the news from Shanghai, Beijing and other places show that myopic surgery has appeared to be a "wave of return to work", and the ophthalmology departments of some comprehensive tertiary hospitals are receiving patients every month who request to return to work because of failed surgeries. Monthly consultation due to surgical failure to request re-operation of nearly one hundred patients. According to reports, nearly 70% of the patients who asked for a "return to work" were those who had undergone the earliest invasive myopic surgery, radial keratotomy (RK), more than a decade ago. The RK procedure has been abandoned by most medical institutions because of the high risk of complications.
RK surgery was once "popular" in southern cities. According to Professor Wu Guijun, deputy director of ophthalmology at Nanfang Hospital of Southern Medical University, RK surgery was invented in the 1940s by experts from the former Soviet Union, the former Soviet Union and Japan to do more, in the late 1980s and early 1990s in China. RK surgery is built on the basis of the medical profession's understanding of the human corneal anatomy and physiological function is still relatively shallow, to be by the doctor with their own sense of touch in the peripheral part of the cornea to cut the cornea in a radial pattern, the cornea will be cut. RK surgery is based on the medical community's rudimentary understanding of the human cornea's anatomy and physiological function, and involves the surgeon cutting the cornea radially in the periphery of the cornea with his own sense of touch. Wu Guijun said, RK surgery due to the cornea cut too deep, the cornea is easy to perforate, infection, the patient's eye may be due to external forces and "split in half" after the operation. Especially terrible, is the Japanese doctors on the RK surgery "innovation", they do not cut from the cornea epithelial side, but from the endothelial side of the cornea is not able to regenerate the side of the "knife", resulting in a lot of patients to pay the heavy price of losing their eyesight forever. The good news is that China is following the Soviet method, and RK surgery has largely been replaced by excimer laser surgery.
Experts pointed out that with the continuous updating of surgical equipment and examination instruments, surgical methods and techniques of continuous improvement, the safety of the current excimer laser surgery has been greatly improved compared with the "RK era".
Excimer laser is a fluorinated argon gas mixed to produce an ultraviolet beam invisible to the human eye, is a cold laser. This beam can split several layers of corneal molecular bonds, so that the cellular tissue vaporization, but no effect on the surrounding tissue. Excimer laser treatment of myopia is to use this high-efficiency beam to change the corneal surface curvature of the eye, thus reducing the refractive power of the cornea, to achieve the purpose of accurate correction of myopia.
At present, a new procedure called "individualized cutting" has begun to appear, namely "wavefront aberrometry-guided LASIK surgery". The doctor connects the eyeball aberrometer analysis system with the excimer laser treatment system, which can comprehensively correct the aberration of the human eye, making it possible for the postoperative naked-eye vision to approach or reach the limit of 3.0 human eye vision, representing the latest development trend of myopic laser surgery.
Professor Zhao Jialiang pointed out that there is no absolutely safe surgery in the world. Excimer laser surgery has a history of more than 10 years since its inception, and such surgeries are now widely performed all over the world, with thousands of people regaining clear vision as a result. From this point alone, it is clear that excimer laser has advantages in the treatment of myopia. At the same time, excimer laser surgery, like any other surgery, carries certain risks. More importantly, as the surgery is performed on the normal cornea, it is a kind of "icing on the cake" surgery and is not indispensable. Therefore, medical institutions should analyze all kinds of myopic surgeries and carry them out prudently according to their own conditions. Patients should also have a more comprehensive understanding of the risks associated with this type of surgery before undergoing the procedure, and should choose their hospitals and doctors carefully so that they can ensure their safety.
The core conclusion of the "Concordia Refractive Surgery Long-Term Clinical Outcome Analysis" conducted by Prof. Ying Li and others is that different surgical methods have their own range of indications, with LASIK suitable for the majority of patients, and a variety of surgical options available for low myopia, and LASEK for patients with thin corneas. examination, skillful surgical techniques, strict aseptic operation, and reasonable postoperative medication are important means to avoid serious complications.
The market is huge and there are 600 excimer laser treatment machines in operation
The Ministry of Health has issued more than 1,000 "induction certificates"
Millie is 33 years old this year and is a company employee in Beijing, with more than 1,000 degrees of high myopia, which used to keep her away from the race over the "bottom of a beer bottle". In the spring of this year, she was determined to say "bye bye" to the "bottom of the beer bottle" that had been following her for decades, so she went to the Department of Ophthalmology of Peking Union Medical College Hospital to undergo LASIK surgery. The moment she took off the blindfold, she was stunned: the black eyebrows of the nurse lady opposite her, the fine lines on her head were so clear that she could count them one by one! The sky outside the window is so blue, so bright ...... she was so excited that a handful of buildings hold her husband's neck, a "super cool", the room amused all the people.
In 2001, the World Health Organization held a meeting of experts from various countries to discuss the treatment of "refractive error" (including myopia, hyperopia and astigmatism), we proposed: "to correct 'refractive error' as an important prevention of blindness. ' as an important task in preventing blindness."
Professor Zhao Jialiang said myopia is a big public ****health problem facing our country. 1998 under the unified arrangement of the World Health Organization, he and his colleagues went to the suburbs of Beijing to carry out a survey on the prevalence of myopia among school-age children aged 5 to 15 years old, and found that at the age of 5 years old myopia in boys and girls is extremely low, and the prevalence of myopia among girls goes up after the age of 8 years old and reaches 55% by the age of 15 years old, and that myopia increases after the age of 10 years old and reaches 55% by the age of 15 years old in boys. The prevalence of myopia in boys increased after the age of 10 and reached 37% at the age of 15. According to the person in charge of the Guangdong Optometric Association, the Association has recently completed an eight-year vision survey of 2.96 million students in Guangzhou, and the results show that the prevalence of myopia among high school, middle school, and primary school students in Guangzhou is 80%, 60%, and 30% respectively. More worryingly, nearly 20 percent of children in kindergartens also have poor vision. Compared with three to five years ago, the prevalence of myopia among students has increased by more than 10 percent....... The extremely large myopic population has a huge potential for myopia treatment due to factors such as schooling, employment, recruitment, conscription, and the pursuit of a higher quality of life, like Millie.
Latest statistics show that there are as many as 600 excimer laser treatment machines in operation across the country. All over the country's large and medium-sized city hospitals, and even county-level hospitals. 2004 to accept the operation of more than 500,000 patients, has exceeded the cataract surgery patients, resulting in the market competition will inevitably "white-hot". Some technical strength is weak, equipment (some even the introduction of foreign elimination equipment), the environment is not satisfactory small hospitals in order to pull patients, competing prices, and some even below the cost of the price of "losing money to make money". Along with the low price, is bound to be low standard, low quality, doctors "hand tide" and not to mention, the operation process is not standardized, such as the original should be a one-time use of surgical instruments, such as corneal blades, Zhang San used Li Si then use, and such as conjunctival rinse, should be used by one person with a bottle, but the small hospitals a bottle of four or five patients, disinfection is not in place! The information provided by the National Refractive Surgery High-level Symposium held in Beijing on May 21-22 this year also shows that most of the problems arising from excimer laser surgery are concentrated in small and medium-sized hospitals.
Many experts have emphasized that excimer laser surgery is a complex systematic project. It is by no means possible to achieve ideal surgical results by relying only on an experienced surgeon and an advanced laser surgery equipment. Preoperative examination, surgical design, intraoperative operation, patient cooperation, postoperative medication and care, follow-up, etc., each link is closely related to the surgical effect. Therefore, it is necessary to raise the threshold of entry, standardize surgical operations and strengthen administrative supervision.
Li Ying is currently the Chinese Society of Ophthalmology cornea group of excimer laser surgery in the field of head of the Ministry of Health National Medical Examination Center of the national large-scale medical equipment users of the qualification examination of the expert group. According to her introduction, in order to strengthen the access to large-scale medical equipment, including excimer laser and the use of supervision, the Ministry of Health as early as 1998, commissioned by the Chinese Medical Association to start the implementation of the name of the "large-scale medical equipment users pre-service training" of the national continuing medical education program, after the training by the examination is issued to those who passed the qualification certificate. So far, more than 1,000 ophthalmologists with a medical license have obtained the qualification of using excimer laser. The training is held once a year, from the initial less than 100 people each time to enroll, to last year at once reported nearly 600 people. Li Ying said, on the one hand, this confirms that excimer laser surgery is indeed "fire", on the other hand, it also shows that the standardized management of excimer laser surgery more and more attention.
Myopia surgery can't be a "cure" for myopia
Experts call for further strengthening of advertisement regulation
Last year, at least 500,000 people underwent excimer myopia surgery nationwide. Does this mean that China has lost half a million myopia patients? The experts' answer is no.
Professor Zhao Jialiang pointed out that at this stage, all the treatments for myopia are "symptomatic" treatments, not "cause-specific" treatments, and excimer laser surgery can only "correct vision", but not "correct the cause of myopia. Excimer laser surgery can only "correct vision", but not "cure" myopia. Every patient who has undergone or is about to undergo excimer laser surgery should be clear: the surgery can only allow you to remove glasses, and cannot change the nature of your myopia. Take a simple example: if the preoperative myopia of 1000 degrees, after the operation naked eye vision of 1.0, without glasses, although the surface looks and normal people, but your intraocular structure, the retina is still the original state of high myopia, all the high myopia may occur complications, such as glaucoma, retinal detachment, etc., are likely to occur, do not need to wear glasses because of eye hygiene and ignore the protection of the eye, and the eye, the eye, the eye, the eye, the eye. Ignore the protection of your eyes.
And excimer laser surgery is not for everyone. The following conditions are not suitable for patients: children and young people under 18 years of age with myopia (because of the refractive system has not been developed); myopia is not stable, in recent years there is still a tendency to deepen year by year; eye active lesions (such as inflammation, glaucoma, severe dry eye, etc.); cornea central thickness of less than 450 microns; other serious eye diseases (such as cornea cone, etc.) or autoimmune diseases, Scarring and severe diabetes. In addition, for those with myopia of 1600 degrees or more, excimer laser surgery is not the preferred method of myopia correction.
"Visual quality is a higher level concept than visual acuity." Dr. Yu Zhiqiang of the Excimer Laser Center at the Eye, Ear, Nose and Throat Hospital of Fudan University said. It requires not only normal vision of 1.0 or higher, but also clarity, comfort, and stability, which involves factors such as aberration, contrast sensitivity, night vision, and tear film stability, in addition to a refractive error that is orthokeratology. The current excimer laser technology can only improve the naked eye vision, but can not improve the quality of vision, on the contrary, the surgery may also lead to a decrease in the quality of vision. Such as night vision decline. A part of myopic patients with more than 300 degrees usually complain that their vision at night is not as good as that in daytime, or they have vision loss when encountering cloudy and rainy days in the early period after excimer laser surgery. In fact, this is a difficult problem that excimer laser surgery has not yet overcome, the main reason is that the surgery makes the patient's visual contrast sensitivity decreased and the aberration increased.
Understanding the above reasoning, people will be able to enhance their immunity to the exaggerated advertisements in the society.
It is reported that, due to different sources of equipment and other reasons, the current excimer laser surgery treatment is still a lack of unified national technical specifications and standards. At the beginning of this year, led by the Wenzhou Medical College, Peking Union Medical College Hospital, Guangzhou Zhongshan Ophthalmic Center, Fudan University Eye, Ear, Nose and Throat Hospital and other more than 10 medical units *** with the participation of the national "Tenth Five-Year" research project "to improve the safety and effectiveness of refractive corneal surgery "The study has been officially launched. This large-scale research will further explore the factors affecting the quality of vision; explore how to comply with the safety, effectiveness, accuracy, stability, the principle of minimal damage based on the same optics to achieve clear, comfortable, long-lasting requirements.
Many experts said in an interview with reporters, strengthening industry guidance, is the most important at this stage to regulate excimer laser surgery, but also operable a strong entry point. It is necessary to come up with nationally applicable guiding opinions through academic exchanges, scientific and technological research and organizational coordination.
The National High-Level Symposium on Excimer Laser Surgery, held in Beijing on May 21-22, focused on the issue of "preoperative" and emphasized the two "strict" words, one is to strictly select patients, and make sure that those who suffer from diabetes and other autoimmune diseases, high intraocular pressure, glaucoma and other diseases. First, strict patient selection, must be those who suffer from diabetes and other autoimmune diseases, high intraocular pressure, glaucoma, corneal inflammation and other patients are excluded; Second, strict doctor entry level, even through the Ministry of Health (commissioned by the Chinese Medical Association) for training, the examination to get a certificate of competence, but also may not let all on the operating table. By taking measures similar to the car driver "annual inspection", to strengthen the supervision and management of doctors who have been on the job. Li Ying said that this meeting will soon be launched before the excimer laser preoperative guidance or recommendations. Next, it will also gradually on intraoperative, postoperative and other series of problems
"each break".
Professor Zhao Jialiang revealed that the national norms and standards for excimer laser surgery are expected to be introduced within the year.
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Currently, there are three kinds of excimer laser surgeries carried out in China -
LASIK: "laser excimer in situ keratomileusis". LASIK is to form a corneal flap on the corneal surface with a microkeratome, and then cut the intermediate corneal stroma with an excimer laser, and then reset the flap afterward. This method preserves the corneal epithelium and the anterior elastic lamina, and is therefore most consistent with the anatomy and physiology of the cornea. The patient's pain is mild and vision recovery is fast (within 12 hours). The disadvantages are that it requires expensive and sophisticated instruments and equipment, high requirements for the surgeon's technical level and the surgical environment, and high surgical fees.
LASEK: excimer laser corneal epithelial resurfacing. It is a corneal epithelial ring drill to cut out an epithelial flap, lift the epithelial flap with an excimer laser in situ grinding, in order to change the refractive error of the cornea so as to achieve the purpose of correcting myopia and astigmatism, and then reset the epithelial flap, avoiding the danger of poor flap production that may occur in the production of corneal flaps in the LASIK surgery, which is suitable for patients with low and moderate myopia who have a thin cornea. The disadvantages are slower recovery of vision, occasional subepithelial clouding of the cornea, and the need to use glucocorticoids for more than two months after surgery.
PRK: excimer laser refractive keratectomy. It is the use of excimer laser characteristics directly on the cornea optical zone cutting. Surgical equipment and operation is relatively simple, low cost, but the patient's postoperative eye pain is severe, and lasts more than 10 days, the need for long-term postoperative glucocorticoid drops, there is a risk of glucocorticoid glaucoma, so this surgery in the country has gradually lost the market.