Source: Eye Future；Editor: SophiaReprint Requirements: Can be reprinted 24 hours after the first publication, source must be acknowledged.Recently, byAier Eye Hospital GroupWang Zheng, the leader of the Refractive Surgery Group and the president of Guangdong Province, performed the surgery.Johnson & Johnson VisionAll-New Generation Femtosecond Laser Corneal Refractive Treatment System ELITA™Officially completed in mainland China at Boao Leye Aier Eye HospitalFirst UnitFemtosecond Laser Corneal Surgery。Four patients were the first to use this innovative device, and their vision recovered well after the surgery. One of the patients achieved a postoperative vision of 2.0.The device in April 2023Obtained FDA 510(k) clearance in the United States。Thanks to the "Pilot First" policy in Boao Lecheng, the brand-new ELITA™ Femtosecond Laser Corneal Refractive Treatment System has been implemented at Aier Eye Hospital in Boao Lecheng, which is not only...The key pilot project in the "Foresee" plan jointly created by Johnson & Johnson Vision and Aier Eye Hospital, which is also the first practice after the announcement of the ELITA™ "Foresee" plan at the CIIE, marking that both parties will accelerate the clinical application of innovative technologies by integrating resources and advantages to benefit patients in China who urgently need refractive correction.According to the "14th Five-Year Plan for National Eye Health in China (2021-2025)," improving scientific myopia correction, cataract surgery for vision restoration, and screening capabilities for common eye diseases are among the key priorities.The plan aims to improve the level of myopia prevention and control and correction, and promote the increase of effective refractive error correction coverage (eREC)., reduce the number of people with visual impairment caused by high myopia, and promote the high-quality development of eye health in China.With the increasing public attention to eye health, the demand for ophthalmic laser surgery continues to grow.
# ELITA™ Femtosecond Laser Corneal Refractive Treatment System
The all-new ELITA™ Femtosecond Laser Corneal Refractive Treatment System, as a high-end ophthalmic laser surgical device launched by Johnson & Johnson Vision,Achieve flapless refractive correction by creating and removing microlenses, altering the corneal surface curvature to correct refraction.. It adoptsThe industry's first symmetrical biconvex lens design，Achieve the cutting of lenses with complete symmetry on both the anterior and posterior surfaces, reduce corneal healing wrinkles and plexus damage, achieve rapid recovery, and improve postoperative visual quality.。
Compared with traditional corneal refractive surgery methods, ELITA™ excels in surgical precision, recovery time, and safety.Significantly improved. Meanwhile, its innovative SILK procedure will not only provide ophthalmologists with a better operational experience but also bring faster recovery and better outcomes in postoperative visual quality for patients.
ELITA™ usesLow-pulse-energy laser, which helps reduce thermal damage to the cornea, thereby protecting corneal tissue. Combined with low pulse energy, ultra-fast repetition rate, and small spot size, ELITA™ can achieveSub-micron precision, ensuring the precision and predictability of the surgery.In addition, thanks toUnique scanning technology and newly designed laser emitter, the lens separation of ELITA™ is smoother, reducing halos and dizziness caused by surgical factors at the root.It can also be used to create corneal flaps for patients undergoing LASIK surgery or other procedures requiring basal lamellar keratectomy or treatment of the cornea., with relatively wide applicability.# Competitive Landscape of SMILE DevicesSmall-incision lenticule extraction (SMILE) is one of the most advanced corneal refractive surgery methods internationally.SMILE surgery does not require the creation of a corneal flap.，but rather performs laser blasting at different depths of the corneal stromal layer in two separate instances, creating a stromal lens, which is then removed through a 3~4 millimeter micro-incision.
Currently, there are only four devices globally capable of performing the full femtosecond SMILE (Small Incision Lenticule Extraction) surgery, which areZEISS's VisuMax, Johnson & Johnson's ELITA™, ZIEMER's FEMTO LDV Z8, SCHWIND's ATOS。
The number of SMILE procedures in China has exceeded 6 million cases.Currently, only ZEISS has been approved in China.In China, most hospitals use the ZEISS VISUMAX 500. The new generation VISUMAX 800 has been introduced abroad but has not yet fully entered the Chinese market. Currently, it has been introduced at the Boao Super Hospital in Hainan, where multiple successful surgeries have been performed. In addition, equipment from other manufacturers is being prepared for domestic market entry.
In January 2024, ZEISS announced the full-fledged femtosecond laser system equipped with SMILE pro software under its company.VISUMAX 800 Receives FDA Approval。
VISUMAX 800 is the second-generation femtosecond laser corneal refractive treatment system launched by ZEISS (the first generation being VISUMAX 500), representing a technical upgrade from the VisuMax 500.Laser pulse frequency increased to 2000kHz, four times that of the previous generation, significantly reducing operation time,Micro-lens cutting can be completed in less than 10 seconds, and corneal flap creation in about 5 seconds.. This generation of equipment is designed to be more compact, offering flexible adaptation to the operating room environment.
In addition, the SMILE pro software is a professional program designed by ZEISS, featuring tools such as cyclotorsion compensation, centration support, and a user nomogram for collecting and analyzing patient data.The device also features the PatientSky lighting system., effectively alleviating patients' intraoperative anxiety.FEMTO LDV Z8, developed by Ziemer Company in Switzerland, is crucial for key steps in cataract surgery, such as clear corneal incisions, capsulotomy, and nucleus segmentation.All are digitally controlled and completed by the product's computer system, asThe remaining procedures were completed with phacoemulsification and aspiration.The innovative CLEAR technology offers adjustable incision placement, single or double incision options, and astigmatism correction., meeting the personalized needs of different patients and optimizing postoperative visual quality.
- Nanojoule Femtosecond Technology：With its low energy, high frequency, small spot size, and continuous coverage cutting features, it enhances surgical precision.Making the capsule membrane cutting edge smooth and even,Capsulotomy integrity rate is as high as 99.9%, the corneal incision position and capsulorhexis effect are more ideal, significantly improving surgical safety.
- OCT Image Navigation System：Visualized Precision Surgical Planning to Enhance Surgical Safety; High-quality color images display details clearly, including blood vessels and even the iris; automatic detection and recognition of anatomical surfaces such as the pupil and corneal edge for precise trajectory planning; automatic detection and planning of a safe surgical range.
In China, the most commonly seen equipment is SCHWIND's Amaris 1050 excimer laser device, which has the highest excimer laser ablation frequency globally. Its laser pulse frequency reaches up to 1050Hz, making it the first device to usher in the kilohertz era.The core technology of the new generation ATOS femtosecond laser includesHigh-Precision Pupil Recognition and Static Rotation Compensation Function, ensuring surgical precision, achieved accurate center positioning when correcting high astigmatism,Supports corneal flap creation for minimally invasive lens extraction (SmartSight) and femtosecond laser-assisted in-situ keratomileusis (FemtoLASIK).Innovative curved patient interface design further enhances surgical comfort, while the optimized lens geometry helps to save corneal tissue.The machine has a high degree of automation, making it easy for doctors to operate. With just a light touch on the screen, key steps such as negative pressure suction and central positioning can be automatically completed.
The pulse frequency of the ATOS system is up to 4MHz., combined with precise pulse characteristics and positioning algorithms,Significantly shortened the treatment and cutting time。The lenses and corneal flaps generated by the device have high uniformity and smoothness, making the lens removal process easier while reducing corneal thermal effects and optimizing postoperative visual contrast sensitivity. Currently,ATOS has launched real-world research in Boao Lecheng, China。
# Progress of Chinese-produced EquipmentIn recent years, Chinese brands have made remarkable breakthroughs in the semi-femtosecond and full-femtosecond fields. Although they have not yet been widely used in clinical treatment, significant progress has been achieved.StrikeBreaking Technical Barriers and Achieving Domestic Substitution Has Become a Major Consensus in the Development of China's Medical Devices.In May 2024, Xianwei Vision Technology (Nanjing) Co., Ltd. developed a product with 100% independent intellectual property rights.The first domestically produced "Femtosecond Laser Corneal Refractive Surgery Device" (Finevision2000) rolls off the production line in Nanjing。Nearly a thousand animal experiments and laboratory studies have been completed so far. The registration clinical trials are being expedited, with the hope of gaining regulatory approval and market entry soon, breaking the monopoly of imported "SMILE" surgical products.The product extends multiple innovative functions.，A more user-friendly human-computer interaction interface facilitates doctors in designing surgical plans, simplifies operational procedures, and supports AI-based personalized surgical planning. There is also a more scientific and intelligent approach to the localization of laser corneal refractive surgery ablation centers. Additionally, a postoperative surgical outcome parameter feedback system has been incorporated, making corneal refractive surgeries more precise and potentially improving postoperative visual quality.February 2021,Tupai Medical "East Sea Plan" Femtosecond Laser Refractive Surgery System Project Officially Launched, Tupa Medical and the Chinese Academy of Sciences have signed a joint development agreement for this project.The project is jointly advanced by the team of experts who invented femtosecond laser, the team of professors from the Chinese Academy of Sciences, and Tupai Medical. Tupai is responsible for the engineering, industrialization, and market promotion of the product.As of now, the joint teamThe first-generation prototype "Donghai No. 1" has been completed and animal ex vivo experiments have been conducted.This is also the first femtosecond laser refractive surgery system prototype based on fully independent technology in China, achieving a "zero breakthrough."
Tupai Medical "Donghai No.1" Femtosecond Laser Refractive Surgery System Prototype (Details Blurred)
Tupai Medical Femtosecond Laser Prototype Animal Ex Vivo Test (Porcine Eye) and First Corneal Surgery Trial Results
Xin Femtosecond MedicalTherapyXin Femtosecond Medical is an innovative team co-founded by Dr. Sun Hui, a "Hundred Talents Program" researcher at the Academy of Opto-Electronics, Chinese Academy of Sciences. The company is positioned as the only company in China with full proprietary intellectual property rights for the research, development, and industrialization of all types of femtosecond laser equipment.This system is not only suitable for the correction of eyeball refractive problems (myopia, presbyopia), but can also be widely used in the treatment of corneal diseases and injuries, including cataracts, glaucoma, etc.。
Mr. Li Quanbin, Co-founder and CEO of the CompanyIt was revealed that the company has achieved positive results in phased research and development as well as overall layout. The phased achievements not only cover the key technologies of the equipment but also include multiple innovative applications.V-Fast Photon
In January 2024, Beijing Weikai Photon Technology Co., Ltd. successfully delivered to a domestically produced high-end ophthalmic medical equipment manufacturer with world-leading standards.Customized SMILE Eye Surgery Laser。
This productFemtosecond laser specifically developed for myopia refractive surgery, pulse width 200-400fs, repetition frequency adjustable from 0.5-5MHz, pulse energy ≥1.2μJ, beam quality M2<1.2, with aerospace-grade stability, providing highly reliable light source support for all-femtosecond ophthalmic surgeries.
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