Frost & Sullivan releases the 'Blue Book on the Current Status of Digital Treatment for Amblyopia and Strabismus in Chinese Children' (with full text available for download)

Total word count: 4,601, Reading time for in-depth understanding: 8 minutes

Amblyopia refers to a condition where, during the visual development period, the best corrected visual acuity of one or both eyes is lower than that of the corresponding age group due to uncorrected strabismus, uncorrected anisometropia, uncorrected high refractive errors, or form deprivation; or when there is a difference of two lines or more between the binocular visual acuities, with the poorer eye being considered amblyopic. According to the laws of children's visual development, the normal lower limit for vision in children aged 3 to 5 is 0.5, and for children aged 6 and above, it is 0.7. Amblyopia often causes low vision and affects binocular visual function, impacting the patient's life, learning, mental health, and career choices.

Strabismus refers to all cases of misalignment of the eyes, which can cause damage to binocular vision. The most common types are esotropia (eyes deviating inward) and exotropia (eyes deviating outward). Strabismus not only affects appearance but can also lead to amblyopia and varying degrees of loss of binocular visual function.

The 'Blue Book' sorts out the definitions, mechanisms of occurrence, disease burden, epidemiology, as well as unmet needs in clinical classification, diagnosis, and traditional treatment methods for amblyopia and strabismus. For more detailed content, please refer to the complete version of the Blue Book.

In recent years, people have increasingly recognized that amblyopia is a developmental cortical disorder of the visual pathway, mainly due to abnormal visual stimulation reaching the cortical cells of both eyes. Essentially, it is a binocular vision problem. Currently, the mainstream treatment method for amblyopia is occlusion therapy. Although occlusion therapy emphasizes improving the vision of amblyopic eyes, it has poor compliance and cannot improve binocular visual function.

With the continuous deepening of understanding of amblyopia treatment theories, clinical binocular vision therapy has been proposed. This involves strengthening the stimulation of the amblyopic eye while both eyes are receiving treatment, thereby improving amblyopic visual acuity while establishing or enhancing binocular visual function. Similarly, for children with strabismus after surgery, binocular vision therapy is beneficial for eliminating suppression, expanding the fusion range between the two eyes, and establishing stereopsis.

Digital therapy is based on binocular dichotomy and visual perception learning theory. By combining computer vision technology, it integrates rehabilitation treatment for visual dysfunction with computer multimedia or computer games. According to the psychological characteristics of children, appropriate perceptual learning tasks are designed. Through various biological stimuli, it enhances the children's visual information storage, cognition, processing, and handling abilities, as well as improves their coordination level of eyes, brain, and hands, thereby comprehensively improving the children's visual function. At the same time, compared to traditional training methods, digital therapy technology has advantages such as strong interest, diverse training models, and shorter treatment times, greatly improving the compliance and convenience of children's treatment. It can be used for children with visual impairments such as amblyopia, strabismus, insufficient fusion function, and abnormal visual information processing.

Current training methods for digital therapy include: binocular divergence training, interactive binocular treatment, binocular push-pull training, VR virtual reality headset training, multimedia training system therapy, and functional training software therapy.

Currently, the FDA has approved two digital therapy products for strabismus and amblyopia: Luminopia One from the American company Luminopia and CureSight from the Israeli company Novasight. According to the approved data, both digital therapy products for strabismus and amblyopia have shown better efficacy compared to traditional therapies. For example, the Luminopia One treatment system uses virtual reality (VR) technology to allow children with vision impairment to watch TV programs or movies modified by specific algorithms to improve their vision. In a pivotal Phase III clinical trial of this digital therapy, a total of 105 children aged 4 to 7 with amblyopia were randomly divided into an experimental group and a control group. The experimental group received the Luminopia One system along with glasses treatment, while the control group only received glasses treatment. After 12 weeks of treatment, the results evaluated using a logarithmic mean absolute deviation (logMAR) visual acuity chart showed that the average improvement in vision for amblyopic eyes in the experimental group was 1.8 lines, compared to 0.8 lines in the control group. Moreover, 62% of patients in the experimental group had a vision improvement of more than 2 lines, while this figure was only 33% in the control group.

The first digital therapy product for strabismus approved by the National Medical Products Administration (NMPA) in China is Multi-Purpose Vision Therapy (Multi-Power), developed by Vision Medical. In a clinical trial comparing Multi-Power with traditional methods for treating children's amblyopia, 214 children aged 3 to 12 with amblyopia were randomly divided into an experimental group and a control group. The experimental group was treated with Multi-Power, while the control group received traditional comprehensive treatment. After 36 weeks of treatment, the results showed that the overall effective rate of the experimental group was 88.75%, compared to 55.88% for the control group.

Poor adherence to traditional treatments has always been a common clinical issue, limiting the effectiveness of clinical treatment outcomes. Digital therapy products for strabismus and amblyopia often take the form of games or VR experiences, which eliminate the boredom of traditional treatments, provide a better patient experience, significantly improve patient compliance, and enhance treatment outcomes.

Currently, 19 digital treatment products for strabismus and amblyopia have been approved for Class II medical device certification.

For detailed information on the approved products and the current status of digital treatment research for Chinese strabismus and amblyopia, please refer to the full version of the Blue Book.

To accurately understand the current application status of digital therapeutics in the treatment of strabismus and amblyopia in children in China, an expert group conducted a survey among doctors. This survey was divided into qualitative and quantitative parts. The results of the qualitative survey can be found in the full version of the blue book, while this article will focus on presenting the quantitative survey results.

The total sample size for this survey was 200 doctors. In terms of different types of hospitals, there were not significant differences in the outpatient proportion of patients with strabismus and amblyopia. The number of outpatient visits to ophthalmology departments in public general hospitals and specialized ophthalmic hospitals was slightly higher than that for strabismus patients, while the number of outpatient visits to specialized ophthalmic hospitals in non-public settings was less than that for strabismus patients. Among strabismus patients, 62% had exotropia and 38% had esotropia. For amblyopia patients, the proportions of refractive amblyopia and anisometropic amblyopia were roughly similar, totaling 66%.

Source: Frost & Sullivan report

When treating strabismus patients, the most common treatment plan chosen by doctors is to correct refractive errors, accounting for 51%, followed by visual function training software (digital treatment products), which accounts for 30%. In the treatment of amblyopia patients, doctors often choose to correct refractive errors and occlusion therapy, accounting for 60% and 52% respectively, with digital treatment products (visual function training software) accounting for 34%.

Source: Frost & Sullivan report

Among patients with strabismus, 62% have exotropia and 38% have esotropia. For amblyopic patients, the proportion of refractive amblyopia and anisometropic amblyopia is roughly similar, totaling 66%.

In this survey, 72.5% of the surveyed doctors (n=145) had used digital treatment products. Doctors were asked to rate the considerations and importance of choosing digital treatment. Overall, the factor 'patient's active request' received the lowest importance score, while doctors considered 'obtaining binocular vision' as more important or the most important factor. In terms of hospital classification, public general ophthalmic hospitals showed the closest trend to the average, while public specialized ophthalmic hospitals fluctuated more significantly.

Source: Frost & Sullivan report

In the treatment of strabismus and amblyopia, digital therapy products offer a variety of visual training modules that cover the necessary methods for visual training therapy; they can produce rich multimedia bio-stimulation patterns according to individual conditions; they have functions such as patient training management and electronic medical record management to improve doctors' work efficiency; and they can customize targeted training programs based on relevant examination data. Among the 145 surveyed doctors who have used digital products, doctors have a high overall recognition of digital therapy products, with most products scoring above 7.5 points. Approximately 41% of doctors mainly use the multi-bao visual therapy product, followed by Zengshining and Shixin.

Source: Frost & Sullivan report

Regarding the effectiveness of digital treatments, 92% of surveyed doctors believe that patients (parents) are 'quite satisfied' or 'very satisfied' with the digital treatment outcomes, while only 8% think it is 'average'. In the field of strabismus and amblyopia, doctors believe that the advantages of digital treatment mainly manifest in 'high child compliance' and 'personalized patient treatment', with proportions of 78% and 74% respectively (multiple-choice question).

Regarding the key development priorities for future digital treatment of strabismus and amblyopia, approximately 80% of surveyed doctors believe that 'accumulating clinical evidence', 'individualized patient treatment', 'greater participation by professionals', and 'emphasizing basic research' should be the secondary priorities for doctors, with proportions of 65% and 59% (multiple-choice question), respectively.

Source: Frost & Sullivan report

Overall, the qualitative and quantitative research shows that with increasing attention from patients and their families to the disease and their enthusiasm for seeking medical treatment, the consultation rate has significantly increased. There are various treatment methods for strabismus and amblyopia. When treating amblyopia patients, doctors often choose to correct refractive errors and occlusion therapy; when treating strabismus patients, doctors often choose to correct refractive errors. Most of the surveyed doctors have used digital treatment products and have a high overall recognition of different products. Over 90% of the surveyed doctors believe that patients (parents) are satisfied or very satisfied with the digital treatment effect. Compared to traditional treatments, digital treatment has many advantages, but it still needs to be standardized, evidence-based medical evidence accumulated, and individualized treatment for patients promoted.

The 'Blue Book' analyzes the regulatory frameworks and product access pathways for digital therapeutics in China and the United States, the market potential of ophthalmic digital therapeutics, the drivers of the market, its development trends, as well as investment and financing cases of ophthalmic digital therapeutics companies. For more detailed content, please refer to the complete version of the Blue Book.

Vision Medical is a global leader in digital ophthalmology therapies. It has developed the world's first digital therapy product for myopia prevention and control, as well as the first VR digital therapy product for strabismus and amblyopia treatment in China. Both products have obtained Class II medical device registration certificates from the National Medical Products Administration (NMPA). Vision Medical provides a range of independently developed innovative products and comprehensive solutions, including visual training network medical platforms, VR wearable smart devices, eye-tracking technology, AI vision screening systems, and AI intelligent plan formulation systems. As of October 2022, the company holds 22 authorized patents, 36 software copyrights, 100 art works copyrights, and 56 registered trademarks. Its business covers more than 30 provinces (autonomous regions, municipalities directly under the Central Government) across the country, and has established stable cooperative relationships with over 2,000 hospitals.

• Product: Doboso, a visual assistant for business automation

It is a visual function training and treatment software. Based on the plasticity of the brain's nervous system and according to the mathematical model of visual neuron receptive fields, it uses the method of 'multimedia bio-stimulation + visual perception training' to open up the patient's visual pathway directly to the visual central system, improving the information processing function of the visual system nerves, so as to achieve the purpose of treating strabismus and enhancing visual function. According to different conditions of patients, personalized multimedia bio-stimulation treatment plans can be generated with thousands of variations, paired with rich visual training content, including 6 major training modules, 8 categories of training functions, 172 training items, 216 stimulation modes, and 1,772 training patterns.

• Product: Beibei Le BaBy Blissful

The world's first digital therapy product approved for myopia prevention and control integrates red light phototherapy, VR adjustment training, and VR visual function training. It allows the eyes to undergo ciliary muscle adjustment training in real-time through hand-eye-brain coordination when they are highly active due to red laser irradiation, which promotes blood circulation in the fundus. This achieves the effect of delaying eye growth, controlling myopia progression, and making myopia prevention and control yield a synergistic result greater than the sum of its parts (1+1+1>3).

Luminopia is an American ophthalmic digital therapy company founded in 2015, dedicated to using digital technology to provide treatment for neurological visual impairments. The company's product, the Luminopia One system, was approved by the FDA in October 2021 and is the first digital therapy for treating amblyopia in children. The product provides different TV and movie content to both eyes through a VR headset device to promote the use of amblyopic eyes and encourage the working of both eyes together for better visual outcomes. Luminopia One is targeted at the B2B market and will be prescribed by ophthalmic care professionals and distributed through online retail pharmacies. In addition to amblyopia, the company has developed software products for visual rehabilitation targeting strabismus, cortical blindness, and traumatic brain injury with the University of Rochester, Northeastern University, and the University of Maryland, respectively.

NovaSight is an Israeli optometry innovation company founded in 2016, providing visual health care solutions for all ages based on eye movement tracking, including visual function screening and diagnosis, amblyopia treatment, and myopia prevention and control. NovaSight has two core products: the CureSight amblyopia treatment system and the EyeSwift visual function screening and diagnostic system. The CureSight system uses an eye movement tracking technology-based 3D image processing algorithm, allowing patients to wear red and blue therapeutic glasses to watch any video content online for amblyopia treatment. This product was approved by the FDA in September 2022; the EyeSwift Pro system is a comprehensive vision assessment device consisting of an optical image sensor, automatic switching glasses, red and blue glasses, and a cloud-based monitoring system. It can provide accurate, rapid, and fully automated visual function screening and diagnosis for clinical use, covering all age groups.