Existing widespread use in China
RLRL therapy’s efficacy and safety has been validated through a comprehensive ongoing clinical trial program. The results, published in leading peer-reviewed scientific publications show that controlled exposure to the Eyerising Myopia Management Device RLRL therapy can control the progression of myopia. By improving the metabolic rate and blood flow of the surrounding structure of the eye, we can strengthen it and control the growth of the eye’s axial length.
How the Eyerising Myopia Management Device works
In a normal eye, light passes through the lens with the focal point correctly reaching the retina.
As myopia progresses, axial lengthening and focal point mis-alignment increase. Continued axial lengthening and focal point misalignment leads to high myopia.
The device delivers RLRL therapy to the retina.
Blood flow is stimulated to help slow the axial length’s further elongation and control myopia’s progression.
The device delivers Repeated Low-Level Red-Light therapy to the ocular fundus.
Blood flow is stimulated and increases to rethicken the choroid layer to help slow the axial length’s further elongation and control myopia’s progression.
See reference (1)
See reference (2)
Extensive clinical trial program
An extensive clinical trial program has established the impressive effectiveness and safety of using Repeated Low-Level Red-Light (RLRL) therapy and the Eyerising Myopia Management Device for the treatment of myopia. In addition to the six peer-reviewed clinical papers located in the Science Hub, there are currently multi-ethnic clinical trials underway in Australia and the USA and high and adult myopia clinical trials underway in Japan.
Achieving up to 87.7% myopia control efficacy when patient has >75% compliance¹
Overall, children in the RLRL-plus-spectacles group had a 76.6% reduction in myopia progression compared with children in the single vision spectacles-only group (SVS). There was an 87.7% reduction in children who had high compliance with the treatment schedule (>75%). There were no known significant side effects, and the overall, the treatment was well tolerated by the children participating in the trial.
At the end of this study, the participants were invited to enrol in a follow-up study for a further 12 months.2 Those children who continued with RLRL therapy had a 75% reduction in myopia progression, and those who switched to RLRL therapy in the second year had a 31% reduction in myopia progression when compared with those children who stayed with SVS. Visual acuity remained the same with no known side effects or severe adverse events.
View our most important scientific papers
A 12-month clinical trial conducted on 264 participants published on Ophthalmology
24-month follow-up clinical trial conducted on 199 participants published on CEO
Clinical trial to assess the efficacy and safety of treatment in controlling myopia progression compared to a sham device with only 10% of the original power published on Ophthalmology
A multicenter, randomized controlled trial (RCT) to evaluate longitudinal changes in macular choroidal thickness in myopic children treated for one year with the treatment published on Ophthalmology
Clinically Significant Axial Shortening in Myopic after RLRL
Axial Shortening in Myopic Children after Repeated Low-Level Red-Light Therapy
Is the Device Safe?
Eyerising Myopia Management Device is a classified an ANSI Group 1 Instrument
Rigorous product testing and safety assessment has been undertaken on our device. The testing process was conducted in accordance with the ANSI Z80.36-2021 standard, ensuring that our device meets the latest safety requirements and guidelines. The testing report was issued on 08 January 2023 and provides assurance of our commitment to delivering a safe and effective solution for managing myopia.
The ANSI Z80.36-2021 standard was developed by the American National Standards Institute (ANSI) that specifically addresses the safety requirements for ophthalmic instruments that that direct optical radiation into or at the eye. The standard focuses on the potential light hazard of these instruments when used in the field of optometry and ophthalmology. For the purpose of this standard, ophthalmic instruments are categorized into two groups to differentiate instruments that may pose potential hazards from those that do not.
Figure 1
Our device was tested by Laser Product Safety, LLC (who is authorised by the FDA ASCA-accredited testing lab, CertifiGroup in accordance to ANSI Ophthalmic – Light Hazard Protection For Ophthalmic Instruments standard). The device has successfully achieved a Group 1 instrument classification (Figure 1), indicating no potential light hazard exists.
During the comprehensive testing process, several important results can be highlighted that provide valuable insights into the safety profile of the RLRL device. Notably, for the retinal photochemical aphakic light hazard, the evaluation of E(A-R) yielded a value of 0.0797 μW/cm², which is “well below” the limit of 440 μW/cm² (Figure 2).
Figure 2
Additionally, regarding the unweighted anterior segment visible and infrared radiation irradiance EVIR-AS, the assessment of E(VIR-AS) indicated a value of 79.71×10-6W/cm2 which fully complies with the limit of 4w/cm2. Furthermore, the evaluation of retinal visible and infrared radiation thermal hazard EVIR-R yielded a value of 27.357 x 10-6 W/cm², which is well below the limit of 0.7 W/cm² (Figure 2).
At Eyerising International Pty Ltd, we are dedicated to revolutionizing eye care through our cutting-edge ophthalmic RLRL myopia therapy. Our commitment to safety, efficacy, and patient well-being drives us to develop exceptional products that consistently meet and surpass the highest industry standards.
To request the full report, please contact on us: info@eyerisinginternational.com
International Approvals & Regulatory Status
The device meets the quality, safety, and efficacy standards required by medical regulators in over 30 countries across Europe and Australasia, with many more coming soon.
- Eyerising International is ISO 13485:2016 certified by notified body BSI.
- CFDA approved as Class II medical device
- CE mark as Class IIa medical device
- MHRA approved Class IIa in UK
- MedSafe Class IIa in New Zealand
- TMMDA approved Class IIa in Turkey
References
- Jiang Y, Zhu Z, Tan X et al. Effect of Repeated Low-Level Red-Light therapy for myopia control in children. Ophthalmology 2022; 129 (5): 509–519.
- Xiong R, Zhu Z, Jiang Y et al. Sustained and rebound effect of Repeated Low-Level Red-Light therapy on myopia control: a 2-year post-trial follow-up study. Clinical & Experimental Ophthalmology 2022 (August); published online ahead of print. 3. Dong J, Zhu Z, Xu H et al. Myopia control effect of Repeated Low-Level Red-Light therapy in Chinese children: a randomized, double-blind, controlled clinical trial. Ophthalmology 2022 (August); published online ahead of print.
- Compliance report IEC 60601-1-2:2014
- CFDA website: https://www.nmpa.gov.cn/
- Xiong, Ruilin, et al. “Longitudinal changes and predictive value of choroidal thickness for myopia control following Repeated Low-Level Red-Light therapy.” Ophthalmology (2022).
- Dong, Jing, et al. “Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial.” Ophthalmology (2022).
