Lumintec Announces First-Ever Domestic Trifocal Intraocular Lens 'ShiQuanJi®' with Successful National First Implantation

Dec 26, 2024 10:55 CST Updated 10:55

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Source of the article: Eye Future ；Editor: Sophia

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Recently, Academician of the International Academy of Ophthalmology, Dean of Zhejiang University Eye Hospital, and Director of the Ophthalmology Center at Zhejiang University Second HospitalProfessor Ke YaoCompletedThe First Chinese-Made Trifocal Intraocular Lens "VisionPro"In ChinaFirst ImplantationSurgery。

VisionPro® byVision ProIndependently developed, providing clear and continuous motion vision at far, intermediate, and near distances, with particularly excellent performance in intermediate distance vision.To be launched in September 2024。

Previously, internationally known astrifocal intraocular lenses almost all come from European and American companies, such as Zeiss and Johnson & Johnson Vision., there has not been a truly domestically produced trifocal intraocular lens in China, with constraints mainly lying in material design, optical design, and product registration. The official launch of Vision Pro® this time,Marking the Beginning of the Application of China-Made High-End Trifocal Intraocular Lenses。

# Surgical Details

Professor Yao Ke performed the implantation of new intraocular lenses for two patients inFemtosecond Laser-Assisted Cataract SurgeryWith the support of technology,Each surgery was successfully completed in less than 20 minutes.。

The first patient to undergo the surgery was Ms. Ye, a 76-year-old woman. Before the operation, her corrected distance vision in both eyes was barely 0.4. Due to her daily need for sewing and passion for practicing Tai Chi, her vision had fallen far short of meeting her daily needs. However, just one day after the surgery,Her distance, intermediate, and near vision improved to 0.8/1.0/1.0.。

Another patient is Ms. Zhu, 60 years old, who has experienced blurred vision in both eyes for nearly three years. After retirement, watching videos and following TV series have become her main pastimes. She also hopes to achieve full-range high-definition vision through surgery. Due to good eye conditions, Ms. Zhu successfully underwent the surgery.Postoperative distance, intermediate, and near visual acuity recovered to 0.8/1.0/0.8.,告别了视物模糊的状态。

▲Professor Ke Yao Performs Surgery with New Type of Artificial Lens, Photo Provided by Zhejiang University Eye Hospital

Professor Yao Ke introduced: "Presbyopia can be solved by wearing reading glasses, but with the advent of trifocal intraocular lenses,Refractive cataract surgery makes it possible to solve presbyopia, cataracts, and other vision problems in one procedure.." An increasing number of middle-aged individuals between 40 to 50 years old are choosing to undergo cataract surgery earlier due to presbyopia, which aligns with the evolving visual demands in this era of precision refractive care.

# Vision Pro^®Triple-Focal Intraocular Lens

Trifocal intraocular lenses replace the aging lens through surgery,Not only can it treat cataracts, but it can also simultaneously address various vision problems such as presbyopia, astigmatism, myopia, or hyperopia.。It incorporates three focal points for viewing objects at long, intermediate, and near distances into a single lens, optimizing intermediate vision while ensuring the visual needs for both near and far distances.Truly achieves smooth and free transition between far, intermediate, and near vision., the entire process is clear, and no glasses are needed after surgery.

"Vision Pro"^®" trifocal intraocular lens has the following characteristics:

PatentedSmooth Phase Modulation StructureThe beam is dispersed unequally and combinedAxial Progressive Large Depth of Field TechnologyUltimately achieving clear and continuous vision at far, intermediate, and near distances, particularly excelling in intermediate vision.

Smooth phase technology forms smooth phase microstructures, modulates light field distribution, and extends the depth of focus range.When light passes through a smooth phase modulation structure, the smooth steps with peak-to-valley variations disperse the beam non-uniformly. Combined with axial progressive extended depth of field technology,Forming far, intermediate, and near vision that is clear and continuous, especially intermediate vision。

The axial progressive design fits an axial progressive modulation spherical aberration distribution curve based on the human eye's corneal spherical aberration distribution curve and the reserved residual spherical aberration values at different pupil diameters.Adaptive corneal spherical aberration distribution, simultaneously forming continuous dynamic vision.

Reduce traditional diffraction ring sharp points,Reduce glare for patients, decrease the central thickness of the intraocular lens by 11%, and make the intraocular lens easier to insert through a small incision.
OwnedHigh Refractive Index, Zero GlareThe original hydrophobic acrylic。
PatentAchromatic StructureCompress the white light spectrum and utilize a portion of the spectrum that is typically wasted in conventional multifocal intraocular lenses.Increase light energy utilization rate to 89.5%, significantly improving patients' visual quality and vision effects in different environments, and reducing their active perception of glare.。

# Phase 3 Clinical Data

During the data analysis process with the control group, the patients' best-corrected distant visual acuity, intermediate and near visual acuity under the best-corrected distant visual acuity, uncorrected distant visual acuity, uncorrected intermediate visual acuity, and uncorrected near visual acuity,At 3 and 6 months postoperatively, under different environments and spatial frequenciesNo statistically significant difference in contrast sensitivity。

MF60 (Vision Pro)^®) Through diffraction modulation + axial progression,Ensure smooth and continuous transitional vision, can provide vision above 0.6 within a 3D range of extraocular defocus;
MF60 SimultaneouslyExcellent in intermediate vision-2.00D/-2.5D showed statistically significant excellent performance.
By comparing the defocus curves at 3 months and 6 months postoperatively,MF60 has significantly better intermediate vision.(The difference in vision is statistically significant).

InVisual Quality Satisfaction QuestionnaireIn China, a survey on common nighttime optical disturbances was conducted through 13 questions, and the results showed:In terms of nighttime optical disturbances, living comfort, and the absolute percentage of "never experienced" for MF60, all showed excellent performance. Moreover, there was a statistically significant superior performance in the aspect of "whether there is soreness or fatigue around or inside the eyes."

In addition, "Vision Pro^®"A unique design to reduce diffraction rings and sharp points results in significantly less glare compared to other diffractive multifocals, providing patients with a more comfortable visual experience with minimal glare."

# Trifocal Intraocular Lens Market

According to the Journal of Global Health, the population of cataract patients aged 45-89 in China in 2020 was approximately132 million people, among which the population of age-related cataract patients reaches93.83 million people, the population that has gone blind due to cataracts has reached13.32 million people,It is estimated that by 2050, the population of cataract patients in China will reach241 million people。

Intraocular LensIt is an artificial lens made of polymer materials that can be implanted in the eye to replace the natural lens removed during cataract surgery.According to the material, it can be divided into rigid intraocular lenses and soft intraocular lenses.Currently CommonSoft Intraocular LensCan be further divided into:Monofocal intraocular lens, bifocal intraocular lens,Trifocal Intraocular Lens, IOL with EDOF technology, IOL with Toric technology.

Monofocal lenses can only address the issue of cloudy lenses, but they cannot solve common problems such as myopia, hyperopia, or presbyopia for patients.Bifocal and trifocal lenses can provide patients with more visual ranges.

In addition, there are also intraocular lenses (IOLs) abroad that simultaneously incorporate both toric technology and extended depth of focus (EDOF) technology, such as the Tecnis Symfony Toric IOL from Johnson & Johnson Vision.

▲Introduction to Soft Intraocular Lens Categories

▲Price Range of Soft Artificial Crystals

The trifocal intraocular lens market in China is mainlyZeiss and Johnson & Johnson VisionOccupy，In this field,The AT LISA TRI 839MP intraocular lens from Carl Zeiss is the main choice for patients in China.. This crystal model is made of hydrophilic acrylate material and adopts an aspheric structure.

▲ AT LISA TRI 839MP Intraocular Lens

Trifocal Toric Intraocular Lenses Can Be Regarded as the Upgraded Version of Trifocal Intraocular Lenses. In this field,The AT LISA Tri Toric 939M/MP intraocular lens from ZEISS is a primary choice for patients in China.. This crystal model is also made of hydrophilic acrylic material and adopts an aspheric structure.

In September 2023, the state organized the centralized procurement of artificial lenses for the first time at the national level. Multiple foreign companies such as Alcon, Johnson & Johnson, Zeiss, Bausch + Lomb, and Hoya were among the winning bidders, along with several China-produced companies like Aibonuode and Henan Universe., Tianjin Century ConTech, etc.

▲Category of Winning Enterprises in the National Centralized Bulk Procurement of Intraocular Lenses

This round of centralized procurement for intraocular lenses includes eight major types, covering products at low, medium, and high levels. Among them, the representative product for the low-end category is the single-focus non-toric intraocular lens, with 17 imported products and 7 domestically produced products winning bids.In the mid-range product category, only products from Aiborn and Vision Pro were selected.; In high-end products,All selected products of trifocal intraocular lenses and extended depth-of-field (EDOF) intraocular lenses are imported.。

In other words, in terms of the number of中标 products, whether低端, mid-range, or high-end, imported products have obvious advantages; when combined with the procurement volume of various types of products, there is also a significant disparity between imports and domestically produced products.AlthoughThe largest consumption of intraocular lenses is in mid-to-low-end products, while the usage of high-end products accounts for only about 10%. However, for enterprises,The material and technological barriers behind high-end products,It is an important manifestation of the core competitiveness of enterprises and the brand strength of products.

Therefore, even though foreign companies still dominate the high-end category of intraocular lenses, several Chinese manufacturers have broken through.Bifocal Intraocular Lens(Aiborn) and trifocal intraocular lens (Vision Pro)Welcome to the era of domestically produced alternatives, the penetration rate of domestically produced high-end artificial crystals is expected to increase, comprehensively accelerating the replacement of imports.

In addition,Simec's trifocal intraocular lens also entered the "green channel" several months ago., which integrates the MOM technology platform of Vision ProHybrid Diffractive-Refractive Optical Design and High-Order Aspheric DesignThe optical part and support structure are made of soft hydrophobic acrylic copolymer material, ensuring excellent biocompatibility and long-term stability.

# AboutVision Pro

Wuxi Vision Pro Ltd. is a company focused onR&D, Production, and Sales of High-End Ophthalmic ConsumablesA technology-based enterprise, founded in 2010. The company is committed to breaking through the technical R&D bottlenecks and key industrialization technologies of foldable intraocular lenses in China.

One of Vision Pro's main products is"Vision Pro" Trifocal Intraocular Lens, This is the first domestically developed trifocal intraocular lens in China.。Other products include the TS Toric IOL, PRS Preloaded Aspheric IOL, RS Aspheric IOL, MS Spherical IOL, etc., covering multiple fields of high-end ophthalmic consumables.

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