Almost every medical institution admits that summer and winter vacations, art exams, military or civil service exams are the “mini-peak” of the keratoplasty business, but very few institutions will elaborate on the post-review and wearing safety, not to mention the risk of malpractice.
”The first choice for higher education, job recruitment, medical examinations and reluctance to do surgery”, “Wear them overnight and the next day you can take off your glasses; take them off in your sleep” …… These exaggerated ads recommend exactly one These hyperbolic advertisements recommend a lens similar in appearance to contact lenses – the Orthokeratology Lens.
It is becoming popular with teens and test prep brigades. Almost every medical institution acknowledges that there is a “mini-peak” in their keratoplasty business during summer and winter vacations, art exams, military enlistment or civil service exams.
The doctors at the Harbin Aier Eye Hospital know the steps for the civil service exams and reassured the Southern Weekend reporter who came to inquire, “It’s still early, you come two months in advance to check, then wear the first night, the next day you can see very clearly.” According to the hospital website, 2,500 patients have been fitted since 2009.
Shandong Weifang Eagle Vision membrane shaping center of the prescription staff revealed to the Southern Weekend reporter, (after the prescription) 95% of the physical examination passed, recently there are 20 to 30 medical examination waiting to wear. The Hefei Precious Eye Hospital even opened up a green channel for high school candidates, civil servants and conscripts to remove glasses, giving priority to medical treatment.
Behind the hot market is the high price of keratoplasty lenses ranging from 5,000-10,000 yuan per pair, and the use of only two years or less. According to industry estimates, since 2012, the keratoplasty market has added about 150,000-200,000 new users each year, and is still rising at an annual growth rate of 30%-50%.
As one of the most sophisticated organs in the human body, the eye is like a camera. The anterior cornea and lens are equivalent to a convex lens, refracting and focusing light from the outside world to the inside of the eye. The retina is equivalent to the camera’s negative. The optic nerve cells distributed on the retina are stimulated by light and transmit this signal to the brain, and the person can see the object.
Through different distance adjustments, the human eye changes its refractive index to keep the picture clear. However, for some people, the refractive index of the eye becomes larger or the anterior-posterior axis becomes longer, and the focus of the external image falls in front of the retina, so that they can only see the near scene, and for the slightly distant scenery, they can only see a blurred image. The so-called “myopia” is formed.
The keratoplasty lens changes the refractive index by flattening the curvature of the cornea within a certain range, thus reducing the amount of myopia.
”In fact, it is a special design, the lens is placed on the surface of the cornea, the space gap filled by tears, closed eyes through the eyelid pressure, so that the corneal epithelium redistribution, that is, the middle of the cornea thinning, the two sides of the cornea thickening.” Chen Yueguo, professor and attending physician at Peking University Eye Center, explained.
Clinical trials both at home and abroad have shown that if worn properly, the annual growth with keratoplasty lenses can be controlled to within 8-25 degrees, while wearing regular frames can increase by 75-100 degrees.
”It is a reversible, non-surgical physical orthopedic treatment and the best tool available to stop the progression of myopia.” Chu Renyuan, professor of ophthalmology at the Eye, Ear, Nose and Throat Hospital of Fudan University and director of the Ministry of Health Key Laboratory for Myopia, said.
However, Chu Renyuan worry is, originally an advanced, serious ophthalmology technology, in the market driven has evolved into the magic glasses to cure myopia.
”Every 7 children tested only 1 suitable”
In fact, keratomileusis is not new. As early as 1998, it entered the country under another name, “OK lenses”. At that time, the country did not have strict approval and management regulations, which led to the occurrence of eye damage and disability due to improper wearing by consumers in Heilongjiang, Liaoning, Sichuan, Hunan, Henan, Zhejiang and other places.
The most sensational case is that in 2000, a Dalian high school student with glasses led to a grade 8 disability (30% disability rate), and his mother ran for six years for identification. “It was all going haywire back then, and cold boiling water could be used as a disinfectant. Two dozen people are blind, but also to CCTV.” Chu Renyuan still remember the scene.
Around 2007, the keratoplasty lens back to legal status, re-enter the Chinese market. Now has developed to the fourth generation of products, the State Food and Drug Administration will be included in the “level three medical devices”, that is, the country’s highest risk level of medical equipment management scope.
”This is a serious medical practice.” Chu Renyuan repeatedly stressed.
But in reality may not be so serious. Southern Weekend reporter contacted 22 hospitals or specialized medical institutions, including public hospitals, private hospitals and optometric centers, etc., found that the fitting of corneal plastic lenses is very hot, some institutions have over the number of prescription, publicity content does not match the actual, the treatment process is not standardized and other problems.
Among them, only one eye hospital in Chongqing explicitly refused to give more than 600 degrees of vision dispensing request. The attitude of other medical institutions is, “it is recommended to do a fundus examination first, and then see if it is suitable. 600 degrees or more can also wear, really can not wear it is recommended to do laser surgery”.
The Shanghai XiShi optical fitter told the Southern Weekend reporter, “high myopia fitting is more difficult, but the main reference to corneal parameters. If the parameters are suitable, the maximum fitting can be up to 1200 degrees.”
In 2013, the State Food and Drug Administration (hereinafter referred to as “FDA”) issued a document showing that “at present, China has approved the listing of corneal plastic lenses for the correction of myopia up to 600 degrees. diopter of up to 600 degrees.”
In fact, the scope of application of keratoplasty lenses is very strict: the general requirement is that the age of more than 8 weeks old and under 18 years old; myopia is best within 500 degrees; corneal astigmatism should be less than 150 degrees; corneal curvature between 41.00 degrees – 46.00 degrees; the best corrected visual acuity in one eye is more than 1.0, eye pressure is normal; in addition, high corneal eccentricity and a suitable corneal thickness.
”We have only 1 suitable for every 7 children to test.” Chu Renyuan’s Fudan University Hospital also receives a large number of patients.
It is understood that most of the corneal plastic lenses on the market are imported brands, including the United States Euclid, the United States E & E, Japan Alpha, South Korea Lucid and more than a dozen, because of high customs clearance fees, imported products will be more expensive than domestic, “tariffs will be almost 300 yuan / piece”. The manager in charge of the sales of the dream David Chen said, this is the only one approved by the General Administration of Food and Drug in the domestic production of corneal plastic lens enterprises.
Southern weekend reporter interview found that E & E brand corneal plastic lens medical device registration certificate as early as August 16, 2013 has expired, but still on sale.
Follow-up services are difficult to put in place, and the risk of malpractice is covered up
In fact, wearing the right keratoplasty lens is only the first step. The real key is the follow-up and safety of the fitting.
According to the former State Drug Administration’s “Supervision and Administration of Corneal Plastic Lens Operation and Fitting Regulations”, hospitals must establish files on all wearers and keep fitting records and review records to ensure product traceability for a period of 5 years. Follow-up review within the first 6 months at least 7 times, after 6 months regular review, the review includes: refraction, visual acuity, mobility, central positioning, comfort, fluorescein staining, corneal topography, intraocular pressure.
Unfortunately, several patients who had been fitted during the Southern Weekend reporter’s interview did not have a follow-up experience for various reasons.
”This is not an optician dispensing glasses. It must be carried out professionally and strictly in accordance with medical steps. Otherwise, wait until another ten years of eye problems are too terrible.” Chu Renyuan’s worries are not unreasonable, although it is already the fourth generation of products, but adverse reactions can not be completely avoided.
”The biggest concern is the infection and inflammation of the cornea, especially corneal infection.” Dr. Chen Yueguo reminded that patients must have regular checkups and undergo strict care and disinfection maintenance. Because each pair of keratoplasty lenses is individually customized, if the match is not good, too tight or too loose, not only will it not work as a treatment, but will lead to corneal damage. It is known that the percentage of complications with keratoplasty lenses is about 0.3 to 0.5%. This number is 3,000-5,000 per million wearers.
One of the more serious cases occurred in Kunming, where Ms. Wang’s daughter Xiao Ting was prescribed a pair of keratoplasty lenses for her myopia on July 28, 2009, and signed a wearing agreement when she picked up the lenses on August 17. At that time, Xiao Ting had 450 degrees of myopia and 50 degrees of astigmatism in her right eye and 450 degrees of myopia in her left eye. Six months later, the parents complained to Madrigal, saying that Xiao Ting had serious eye problems and her myopia had risen to 1000 degrees. The company, on the other hand, claimed that the patient seriously violated the review requirement on the agreement because she did not go to the company for review and protein removal as required, and did not go to the local hospital for regular checkups as reminded by the company.
The State Food and Drug Administration has also issued a special notice to warn of potential risks: due to environmental and individual differences, there is still a risk of eye diseases such as corneal endothelial cell reduction and macropapillary conjunctivitis even with correct use of keratoplasty lenses. If the fitting is not done as required, it is more likely to lead to increased eye discharge, eye congestion, excessive tears, visual changes, foreign body sensation and other abnormalities, which will increase the risk of eye diseases such as corneal ulcers, keratitis, corneal infiltration, corneal erosion, corneal epithelial damage, corneal floaters, iritis, corneal neovascularization, etc. If treatment is delayed, permanent visual impairment may also occur.
More easily ignored by outsiders is the fact that this is not a treatment for myopia glasses, it is effective in controlling myopia, but the correction effect is reversible. “Without wearing vision will return to the original condition. Our country often marketizes science and over-rides science and technology with marketization.” Zhang Jinsong, director of ophthalmology at the First Affiliated Hospital of Zhengzhou University, lamented.