The curative effect is no different from the same foreign products
Chinese-made intraocular lens is "a bright spot"
◎Reporter Chen Xi
The first domestically developed hydrophilic aspherical foldable intraocular lens has been certified by the European Union in February 2020, and on March 10 this year it obtained the Class III medical device registration certificate issued by the National Medical Products Administration.
The results of a 4-year clinical trial led by Beijing Tongren Hospital of Capital Medical University and jointly completed by 7 hospitals including the Eye Hospital of the Chinese Academy of Chinese Medical Sciences showed that the efficacy of the product is no different from that of the same imported products abroad, and the vision of patients can reach ideal Effect.
Recently, 67-year-old well-known actor Brigitte Lin revealed that she had undergone cataract surgery.
According to statistics from the Ophthalmology Branch of the Chinese Medical Association, in 2020, the number of people aged 45 to 89 in China suffering from cataracts will reach approximately 132 million, and the number of blind people due to cataracts in this population is expected to reach 13.32 million.
Surgery is the only way to cure cataract, and intraocular lens is an indispensable medical optical device for the treatment of cataract, and it is also the most important biological material with the highest output value in the ophthalmology field.
On July 8, at the 21st National Conference on Cataract and Refractive Surgery, Tianjin Century Kangtai Biomedical Engineering Co., Ltd. (hereinafter referred to as Century Kangtai) demonstrated its first domestically developed hydrophilic aspheric foldable intraocular lens .
The launch of this new domestic intraocular lens product provides more options for the treatment of cataract patients.
Implantation of intraocular lens is the main way to treat cataract
"Almost 100% of elderly people over 80 have cataracts." Professor Li Xiaorong, dean of the Eye Hospital of Tianjin Medical University, introduced that at birth, the lens of the human eye is clear and transparent, so you can see things very clearly.
Since the main component of the lens is protein, as we age, the protein gradually ages, becomes cloudy and loses elasticity, resulting in blurred vision.
Cataract is not a patent for the elderly, trauma, poisoning, diabetes and other metabolic diseases may cause cataracts.
In addition, other ophthalmological diseases, such as glaucoma, retinal detachment, uveitis... will be involved in the metabolism of the lens, leading to the occurrence or premature occurrence of cataracts.
"Cataract removal surgery combined with intraocular lens implantation is the main treatment for cataracts." Li Xiaorong introduced that the technology of cataract surgery is now very mature. The phacoemulsification operation is used to remove the cloudy lens and then implant a transparent intraocular lens. The most commonly used method.
After the opaque lens is removed, if the intraocular lens is not implanted, more serious refractive errors will occur, which will seriously affect the life of the patient.
As an implantable device, the intraocular lens is permanently fixed inside the eye, it will not fall off or need to be cleaned, and the patient will hardly feel anything.
More importantly, there is no repulsive tissue at the implanted lens site, and the intraocular lens will not be rejected by human tissues like other implantable materials, so it can be used for a long time.
With the intensification of population aging and the upgrade of diagnosis and treatment consumption, the performance, safety and effectiveness of intraocular lenses have also been paid more and more attention.
"Nowadays, the iterative process of intraocular lenses is accelerating." Mingrui Zhang, the R&D project manager of Century Kangtai, introduced that from the perspective of optical design, intraocular lenses have experienced the development of spherical intraocular lenses, aspheric intraocular lenses and functional intraocular lenses; in terms of materials, they are further divided into Rigid intraocular lens and foldable intraocular lens.
"The iterative upgrade of the intraocular lens has the direct benefit of the patient, that is, the surgical incision is getting smaller, the postoperative effect is getting better and better, and it can reduce the hindrance." Li Xiaorong explained that the foldable intraocular lens can be Fold to 2-3 mm, so that the lens can be implanted with only a small wound during the operation; compared with the aspherical intraocular lens, when the pupil becomes larger, the aspherical intraocular lens will not look like The edge vision of spherical intraocular lens will be distorted, resulting in unreal vision; functional intraocular lens can correct for some vision problems, such as astigmatism, etc., trifocal and multifocal intraocular lens can make patients far, middle and near" All the distances are clearly seen.
"In terms of materials, current intraocular lenses focus on the selection of hydrophilic materials. The hydrophilic intraocular lens materials are soft, non-sticky, and have good biocompatibility, and they are easy to operate when implanted in the eye." Li Xiaorong introduced, hydrophilic. The intraocular lens can reduce cell adhesion, thereby reducing the occurrence of aftermath, and is more biocompatible.
Domestic intraocular lenses continue to improve performance and quality
Although foldable intraocular lenses have become the mainstream of cataract surgical implantation, 30% of cataract patients in China still use hard intraocular lenses, mainly because the price of hard intraocular lenses is lower.
But because it is not foldable, the surgical incision will more than double to 6 mm.
Most of the foldable intraocular lenses used by the remaining 70% of patients currently rely on foreign imports.
As of the end of 2020, the number of domestic cataract surgery patients has reached 4 million, but domestic intraocular lenses account for less than 20%.
Li Xiaorong introduced that my country’s intraocular lens market was almost monopolized by foreign brands in the past, but in recent years, the quality of new domestic intraocular lenses has fully reached the imported level, and some parameters are even better than imported products.
The hydrophilic aspherical foldable intraocular lens released this time is the third intraocular lens independently developed by Century Kangtai. The product includes 7 models and 4 sizes, covering two loop types. Among them, the hollow loop foldable intraocular lens is domestic The first product that can realize the suspension function.
"Compared with spherical lenses, the aspherical design of this intraocular lens can improve the vision of patients in low light and night environments; the zero spherical aberration design avoids overcorrection of spherical aberration caused by individual differences in corneal spherical aberration, and is suitable for all corneal shapes. At the same time, it can effectively reduce the impact of lens eccentricity and tilt on the imaging quality; preserve the positive spherical aberration of the cornea, increase the depth of focus of the human eye, improve the intermediate vision, and meet the requirements of ergonomics." Professor Liu Yongji from the Institute of Modern Optics, Nankai University said The optical design innovation of the product was interpreted in detail.
"Compared with the traditional C-shaped loops and L-shaped loops, the hollow loop design performance is better." Zhang Mingrui explained that during cataract surgery, after removing the cloudy lens, an empty capsular bag will be left, and then the intraocular lens Put it into an empty pouch.
The design of the hollow loop allows the intraocular lens to be adjusted and changed according to the size of the capsular bag, has a cushioning function, and has good stability in the capsular bag.
If the patient is traumatized or the capsular bag is destroyed during the operation, the lens and the periphery can be sutured and suspended and fixed in this position to make the intraocular lens more stable.
It is understood that this domestically pioneered hydrophilic aspherical foldable intraocular lens has been certified by the European Union in February 2020, and on March 10 this year it obtained the Class III medical device registration certificate issued by the National Medical Products Administration.
The results of a 4-year clinical trial led by Beijing Tongren Hospital of Capital Medical University and jointly completed by 7 hospitals including the Eye Hospital of the Chinese Academy of Chinese Medical Sciences show that the efficacy of this product is no different from that of foreign equivalent products, and the vision of patients can achieve the desired results. .
Choosing an intraocular lens is not the more expensive the better
"The choice of intraocular lens is not the more expensive the better, but the one that suits you is the best." Zhang Mingrui reminded.
If you are only able to see clearly in daily life, you can choose a single-focus intraocular lens, and then wear a pair of reading glasses; if you often read books, read the newspaper, play with your mobile phone or drive, but don’t want to wear glasses, you can choose a multi-focus intraocular lens. In particular, the trifocal intraocular lens can solve many problems such as cataract, myopia, and presbyopia at one time, and there is no need to wear glasses after surgery.
Compared with single-focal intraocular lenses, functional intraocular lenses are relatively expensive.
Zhang Mingrui said that functional intraocular lenses are also being developed in China, and the products are already under registration and testing.
In addition, many patients can't see clearly again after one or two years of cataract surgery.
"This is the aftermath of cataract surgery. It is the regeneration of surviving lens epithelial cells during cataract surgery." Zhang Mingrui explained that, visually speaking, it can be understood as leaving the turbid lens in the corner of the capsular bag when removing it. After the "seed" of the cataract is dropped, the seed will germinate and regenerate, causing the cataract to slowly spread from the corner of the lens to the middle.
In response to this problem, the R&D team is developing a 360-degree intraocular lens with a square edge, which can make the lens and posterior capsule tightly fit, inhibit the migration of lens epithelial cells, thereby reducing the occurrence of posterior obstacles.
"my country has the world's largest group of cataract patients. In the past two to three decades, my country has made rapid development in cataract surgery technology and the research and development of intraocular lenses. With the continuous research and development of domestically-made new products, it will bring more domestic cataract patients. Use the domestically produced intraocular lens with the best quality and price." Zhang Mingrui said.