Australian medical device company Eyerising International says its device has been “misrepresented” in a recent study over the safety of repeated low-level red-light (RLRL) in myopia management. The company has provided four counter points to the paper and has taken particular issue with the “possibly malicious” implication that its instrument didn’t meet safety standards the company has been referring to.
Subsequently, Eyerising says it has spoken to the editor-in-chief of the Ophthalmic & Physiological Optics (OPO) journal – where the work was published – who has agreed to give the company the right of reply in the form of a letter to the editor to “address several of the inaccuracies and misrepresentations in [the] article”.
The study: ‘Red light instruments for myopia exceed safety limits’1 was published on 5 January 2024 and authored by Dr Lisa Ostrin, an Associate Professor at the University of Houston College of Optometry, and Dr Alexander Schill, a senior research scientist with a background in biomedical and visual optics also at the University of Houston.
Focusing on two low-level red light (LLRL) devices – Sky-n1201a and Future Vision – the study aimed to characterise the output and determine the thermal and photochemical maximum permissible exposure (MPE) of LLRL devices for myopia control.
The study concluded: “For both of the LLRL devices evaluated here, three minutes of continuous viewing approached or surpassed the MPE, putting the retina at risk of photochemical and thermal damage. Clinicians should be cautious with the use of LLRL therapy for myopia in children until safety standards can be confirmed.”
The article prompted Eyerising to issue a press release on 5 February 2024. The company took issue with several references to the Eyerising Myopia Management Device “in a negative and inaccurate manner; despite having not tested the device or contacted Eyerising International for information or comment”.
The company has addressed four key issues below:
Point 1
Eyerising said that despite having not tested the Eyerising device, the authors of the OPO article wrote: “Of note, for the Eyerising and New Vision instruments used in clinical trials, claims of Class 1 do not appear to be supported by their published measurement data.”
“Eyerising International dispute this statement,” the company said. “Our device does not ‘claim’ a Class 1 designation, it ‘has’ a Group 1 instrument classification, indicating no potential light hazard exists, as defined by the ANSI Z80.36-2021 standard.
“ANSI Z80.36-2021 is the standard which the FDA require Eyerising International and every other manufacturer of ophthalmic laser instruments to meet.”
Point 2
In the conclusion, the authors of the OPO article wrote: “Instrument manufacturers must take into account ANSI standards for lasers used in ophthalmic applications to ensure that the retina is not at risk of photochemical damage.”
In response, Eyerising said the authors themselves did not use the latest ANSI standards required of ophthalmic instruments by the FDA.
“They state in the article that they used the ANSI Z136.1 standard as the benchmark for their tests. While acknowledging that the ANSI Z136.1 standards were developed to protect individuals from accidental exposure to lasers in occupational situations,” Eyerising said.
“There is a more recent ANSI standard specifically for ophthalmic instruments. The ANSI Z80.36 standard specifies fundamental requirements for optical radiation safety for ophthalmic instruments. It applies to all ophthalmic instruments (including current, new, and emerging instruments) that direct optical radiation into, or at the eye. It also applies to those parts of therapeutic or surgical systems that direct optical radiation into, or at the eye for diagnostic, illumination, measurement, imaging, or alignment purposes.”2
The company said it was the ANSI Z80.36-2021 standard that the FDA required Eyerising to meet and which it has obtained.
“The Eyerising Myopia Management Device, unlike the two other devices which the authors did test, also meets the quality, safety, and efficacy standards required by medical regulators in over 30 countries across Europe and APAC, with several more pending,” the statement said.
“Therefore, for the authors of the article to imply that the Eyerising device does not meet the standards it claims is misleading and possibly malicious.”
Point 3
In the conclusion the authors wrote: “In conclusion, based on measurements in our laboratory, it is recommended that clinicians strongly reconsider the use of LLRL therapy for myopia in children until safety standards can be confirmed.”
Eyerising said numerous countries have established such safety standards and unlike the two copycat devices Ostrin tested, the Eyerising device meets the quality, safety, and efficacy standards required by medical regulators in over 30 countries across Europe and APAC.
“Further, the authors’ conclusion, is based on tests of two other devices in the authors laboratory but by implication includes the Eyerising device which they never actually tested but refer to inaccurately several time in their article,” the company said.
“The authors allege possible risks associated with LLRL therapy based on their extremely limited laboratory testing of two copycat devices but ignored and failed to mention that the Eyerising device has a proven safety record in both clinical trial and real-world settings.
“The Eyerising device has undergone 10 clinical trials and four real world studies, covering 1,785 patients, with a cumulative clinical trial use of 9.25 years – with zero significant adverse events recorded. The device has been used to treat more than 160,000 patients in the real world over the past eight years, and there are currently more than 80,000 daily users. To date, there have only been five cases of significant adverse side effects reported; with no permanent damage recorded.”
Point 4
Eyerising also took exception with the authors referencing a case study of a 12-year-old girl in China who experienced an adverse event, without mentioning the patient had not followed the guidelines for the use of the device.
“In fact, the patient had continued to use the device for several weeks after first experiencing prolonged afterimages, which is contrary to the ‘Instructions for Use’ (IFU) issued with the device. Nor did the authors report that a follow-up case study found that the patient had fully recovered,” Eyerising said, with a more detailed outline of this case available here.
“As of December 21, 2022, four months after discontinuing LLRL, the patient’s cornea appeared clear, and the retinal structure was intact. The corrected visual acuity of both the patient’s eyes had recovered to 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.”3
To conclude, Eyerising said it took its responsibility for ensuring the safety and efficacy of its RLRL therapy device seriously.
“We remain committed to working closely with healthcare professionals and users to collect and investigate any adverse reactions and to address any potential concerns,” the company added.
Dr Lisa Ostrin outlines her case
In a press release announcing the results of her study on 29 January 2024, Ostrin said that while the two different LLRL devices assessed in the study were confirmed to be Class-1 laser products, as defined by International Electrotechnical Commission standards, they are unsafe to view continuously for the required treatment duration of three minutes.
“Class-1 lasers are low-powered devices that are considered safe from all potential hazards when viewed accidentally and briefly. Examples of Class-1 lasers are laser printers, CD players and digital video disc (DVD) devices. Class-1 lasers are not meant to be viewed directly for extended periods,” she said.
“Thermal ocular injury from a laser can occur with exposures at any wavelength when the temperature change of the retina is greater than 10°C, resulting in the denaturation of proteins. With thermal damage, the lesion size is typically less than the size of the beam diameter, and the resultant scotomas are permanent.”
Ostrin’s work was funded by the National Eye Institute.
More reading
Eyerising Myopia Management Device granted TGA approval for home-use red-light therapy
O=MEGA23: Highlights from the optometry clinical program
Rare complication case: Eyerising International addresses safety questions
References
1. Lisa A. Ostrin and Alexander W. Schill. “Red light instruments for myopia exceed safety limits”, OPO January 2024.
2. ANSI Z80.36-2016
