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Over a 12-month period, the therapy has shown 69.4% efficacy in controlling axial length elongation.
Eyerising International has addressed questions over the safety of its repeated-low level red-Light (RLRL) treatment for myopia management, following two case reports on a probable “super responder” who experienced afterimages and vision loss, but ultimately made a full recovery.
The patient is among five cases of significant adverse side effects reported among the 80,000 daily users of the device in China. At a rate of 1:20,000, the Australian-based company says side effects with RLRL are extremely rare, and the case in question could have been prevented if treatment cessation guidelines were followed when prolonged afterimages were first noticed.
The Eyerising Myopia Management Device was included into the Australian Register of Therapeutic Goods (ARTG) in the early part of 2023. It also has been cleared for use in the European Union, the UK, New Zealand, China and Turkey.
According to the company, it delivers 180 seconds of 650nm wavelength red light through the pupil to gently stimulate the blood flow in the retina, helping to slow the elongation of axial length and control myopia progression. Studies have demonstrated children who undergo RLRL for three minutes twice a day, five days a week, experience a significant reduction in myopia progression over a 12-month period, with a 69.4% efficacy in controlling axial length elongation and a 76.6% efficacy in managing myopia progression.
Eyerising had its first major Australian showing at the O=MEGA23 conference in Melbourne in September where it held an hour-long session on the treatment and fielded questions over its safety from local practitioners and researchers.
CEO Mr Paul Cooke said that while regulatory approvals recognised the safety and of the device, the company remains hypervigilant of adverse events. One of these cases was highlighted in two separate reports of a Chinese 12-year-old girl, the first of which was published in JAMA Ophthalmology on 25 May 2023, followed by the Chinese journal Chinese Medical Association (CMA) in August 2023.
Cooke spoke to Insight about these findings, particularly the second report in CMA authored by a team that managed the patient’s long-term treatment and covered her previous medical history and the initial presentation of the adverse reaction in greater detail than the first case report, published in JAMA Ophthalmology.
In essence, Cooke said the second report “independently reconfirms the patient has fully recovered”.
“As of December 21, 2022 (four months after discontinuing RLRL), the patient’s retinal structure was intact. The corrected visual acuity of both the patient’s eyes had recovered to the level prior to the treatment (0.8). And OCT imaging showed that the integrity and continuity of the ellipsoid zone in the macular fovea of both eyes had been restored,” he said.
The case in question
According to the CMA report, the patient – a high myope wearing orthokeratology lenses – was first prescribed RLRL in March 2022 after experiencing repeated conjunctivitis.
She followed the standard twice daily treatment protocol, with at least a four-hour interval between each three-minute session. After one month of RLRL treatment, her fundus exam was normal and the refractive power of both eyes regressed by approximately 2.00 D, leading to a change in spectacles. After three months of treatment, the corrected visual acuity was 1.0. and an OCT scan was conducted with no abnormalities detected.
“However, in hindsight the remarkable improvement in refractive power might have warranted further investigation, however the patient was healthy and responding well to RLRL in early July 2022,” Cooke said.
In early August 2022, five months after initiating treatment, she experienced prolonged rainbow-like afterimages following RLRL, occasionally lasting for more than eight minutes. Crucially, the patient and her parents decided to continue treatment and didn’t seek immediate medical attention. The authors of the study highlighted this did not comply with the safety requirements of a 2022 expert consensus on treating children and adolescents with RLRL.
Citing the case report, Cooke said that it wasn’t until August 30, 2022 – when she experienced a decline in vision – that the patient’s mother contacted the staff at the Eyerising Service Centre who advised to stop using the device immediately and to consult doctors if the patient did not improve or if developed new symptoms. Three days later she went to Hunan Children’s Hospital, complaining of redness in the right eye and photophobia.
An ophthalmological examination at that point revealed conjunctival hyperemia in both eyes, and patchy fluorescein sodium staining was observed in the central cornea of the right eye. Both eyes exhibited inadequate accommodation and relaxation. Also, ultra-wide-angle fundus imaging revealed a round lesion at the macular fovea. OCT scans showed discontinuity in the ellipsoid zone of the outer retinal layer at the fovea of both eyes.
The diagnosis was bilateral high myopia, right eye keratitis, left eye conjunctivitis, and retinal changes in both eyes. She was put on an initial course of treatment, and then referred to Xinhua Hospital for additional tests and an MRI scan (where the authors of the JAMA article saw her).
Cooke reported that an MRI showed no abnormalities in the bilateral optic nerves. There were significant abnormalities in the visual fields of both eyes. The multifocal electroretinogram (mfERG) showed a reduction in the amplitude density of the first ring in both eyes, with the disappearance of the central response peak. Both eyes had a slight reduction in the amplitudes of both rod and cone response waves.
After being prescribed further treatment, by late October 2022 – a little less than two months after stopping RLRL therapy – the patient reported gradual improvements in vision. By the next appointment on December 21, 2022, four months after discontinuing RLRL, her retinal structure was intact, Cooke said.
He also noted Eyerising RLRL device’s power measured through a 4mm pupil diameter is 0.29 mW, much lower than the national standards of China, the US, and the International Electrotechnical Commission (IEC), which specify 0.39mW.
“With the evidence from the second case report, it now seems the most likely explanation is that the patient is a super responder to light therapy; as indicated by the remarkable 2.00D myopic regression after the first month of treatment,” Cooke said.
“This is by far the most dramatic response we have encountered during nine clinical trials, and after treating more than 150,000 patients in the real world. As the manufacturer of the Eyerising RLRL device, we are committed to learning from adverse events and case studies, one of the reasons why our OEM (original equipment manufacturer) maintains a hypervigilant side effect reporting centre.”
Key takeaways from two case studies on the 12-year-old myopic girl are, according to Eyerising:
- Side effects with RLRL are extremely rare. Five cases of significant adverse side effects among the 80,000 daily users.
- Patient adherence to the recommendations of the 2022 expert consensus specifically cover the need to cease treatment if extended patient afterimage is experienced and if followed, could probably have prevented this incident.
- Instructions for Use (IFU) and RLRL clinical training stresses the importance of monitoring extended afterimage.
- The patient in this case was probably a super responder to light therapy.
- There are early indications of possible super responders such as early and dramatic myopia revision, and prolonged afterimage following treatment.
- If super responder reactions are suspected they are detectable by tracking-reduced best-corrected visual acuity and OCT changes.
- Importantly, such cases are recoverable upon discontinuing treatment.
- Case reports should include all relevant patient medical history and consider recovery timeframes prior to determining causality and injury severity.
More reading
Eyerising Myopia Management Device granted TGA approval for home-use red-light therapy
Aussies report red light therapy shortens axial length in myopia
Axial length matters in myopia management
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