Is It Possible for Light-Based Hair Removal Home Devices to Induce Ocular Damage? Systematic Review

Introduction

Home-use light-based device manufacturing has grown exponentially over the last few years. Indeed, their popularity increased as a mean of depilation in the privacy of consumers’ homes at a lower cost than in professional settings. Most of those devices are based on intense pulse light (IPL); however, few laser home devices are available on the market.^1,2 The IPL is noncoherent light with a broad wavelength output ranging from 500 to 1200 nm.³ Unlike lasers, pulses are generated from electrical current bursts that stimulate xenon gas-containing chambers. The emitted light is filtered using “cutoff” filters to limit the undesirable lower end of the spectrum minimizing tissue damage.^3,4 IPLs emit broad wavelengths within the visible and near-infrared spectrum diminishing the selective photothermolysis of the specified chromophores. Nevertheless, Cohen et al reviewed the literature, and they stated that the grade of evidence as by the Oxford Centre for Evidence-Based Medicine guidelines for the efficacy of home light-based hair removal devices is A.^5,6

Those devices are under different regulation systems in the United States compared to European countries. While they are considered medical devices controlled by the Food and Drug Administration (FDA) in the United States, Europe continues to consider them as cosmetic products.^2,7 The FDA imposes an obligatory premarket approval (PMA) requisite to make them safe for human use and suitable for consumer use even without healthcare professional supervision. In that term, the FDA is committed to selected laser standards issued by the International Electrotechnical Commission [IEC 60825–1 (Safety of laser products – Part 1: Equipment classification and requirements) and IEC 60601-1-11:2010 (Medical electrical equipment Part 1–11: General requirements for basic safety and essential performance. Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment).⁸ According to the updated IEC 60825–1 Ed. 3.0 b:2014, the international laser standards introduced a new class, class 1 C, designed for laser products requiring contact application to fire.⁹ The home-use light-based hair removal devices fall into class 1, as claimed by their manufacturers, and they might be reclassified into class 1 C, as most of them incorporate safety contact sensors that minimize inadvertent light emissions when the probe is not in direct contact with the skin.^10,11 By that, ocular damage is supposed to be prevented by engineering means. As a result, a good number of IPL home devices are not supplemented with protective eyewear. An emerging concern exists, despite the lower fluence rates of home devices compared to office IPL devices: what if an unprotected eye is inadvertently exposed to light emission? Or what if the consumer tried to overcome the protective safety features? In our experience, some of our patients have already tried to overcome the contact sensors for adjusting the device output window to the curved body parts.

It is essential that IPL home device consumers are well informed regarding the presumed ocular hazards, the precautions that must be taken during the procedure, and the clinical signs of varying ocular complications. We conducted this review to describe the reported ocular complications following IPL exposure, the most common ocular segment that has been damaged, and how the damage was presented clinically.

Methodology

We followed the PRISMA methodology in our search, i.e., Preferred Reporting Items for Systematic Review and Meta-Analysis. Initially, we searched the PROSPERO database to detect duplicate works; however, we did not find any ongoing or published similar reviews. Subsequently, this review was registered in PROSPERO, with an ID number CRD42023429287. Our search strategy is summarized in the study flow chart. An electronic search of the Medline, CENTRAL, Cochrane, and Google Scholar databases was conducted using the terms ocular complication, ocular damage, intense pulse light, and IPL home devices. Furthermore, cited references from the ResearchGate database were further explored to identify any relevant articles. We included articles if they met our inclusion criteria: case reports of ocular damage following exposure to IPL used for dermatologic indications, written in English or in a language reliably translated to English. Papers were excluded if they described ocular injuries after laser exposure other than IPL if the exposure occurred in nonclinical settings or for non-dermatologic indications.

Data were extracted by one investigator and cross-checked by a second reviewer. At the same time, papers were critically appraised using the Critical Appraisal Tools, Joanna Briggs Institute, 2020.¹² The quality checks the adequacy of the patients and their clinical condition description, the presence of conclusive evidence of the diagnosis provided, a clear description of the intervention given and the post-intervention outcomes. Generated data are summarized in an Excel sheet and subsequently tabulated. Dichotomous variables were descriptively calculated using frequencies and percentages.

Results

A total of 18 articles^13–30 including 20 patients were identified in the literature, describing ocular complications following exposure to an IPL source (60%) or to a diode laser (40%) [Figure 1]. Most patients (95%) were female; their mean age was 40 (St. deviation 12). Of those reporting the usage of protective eyewear or not, 40% did not use any protective measure, an additional 30% shifted the protective eyewear during the procedure, and one patient was wearing cosmetic contact lenses during the procedure.²² Three patients reported that they directly looked at the IPL probe while it was fired up.^15,24,27 Eighteen patients (90%) received facial IPL treatment, and 17 of their procedures were performed in a periocular location. Of those reported laser parameters, the fluence used was in the range of 20–24 J/cm².

Figure 1 PRISMA chart flow.

Clinically (Table 1), the symptoms of ocular complications started during the procedure in 7 (35%) patients, a few hours after the procedure in 4 (20%) patients, and within two days after the procedure in 6 (30%) patients. The most reported symptom was photophobia (75%), followed by ocular pain and visual disturbances (60%). Thirty percent of the patients reported eye redness as their presenting symptom. Half of the patients reported left laterality of the injury, 20% reported bilateral complications, and 30% reported right laterality. The most common complication reported was iris atrophy (65%) caused by IPL exposure in 61% of the cases and by diode laser in an additional 38%. Anterior chamber inflammation was the second most common complication, reported in 60% of the cases (Figure 2). Interestingly, the retinal pigment epithelium was damaged in four patients (20%), equally experienced following IPL or diode exposure. In one case,²² where the patient was wearing cosmetic contact lenses during the IPL procedure, the lens pigment was deposited over the cornea, which was corrected surgically using a No. 15 blade.

Table 1 Patient Characteristics, Clinical Settings and Ocular Structural Damages Induced by Intense Pulse Light/Diode Laser

Figure 2 Ocular complications reported following exposure to IPL or Diode laser.

All the reported cases of anterior chamber inflammation improved completely; however, iris atrophy did not. All 14 reported cases of iris atrophy were permanent at the follow-up visits: 6 weeks to 3 years from the injury. Of those 14 cases, 6 cases developed additional ocular complications in the follow-up visits: 3 cases had permanent posterior iris synechiae,^17,19,23 one case developed transient glaucoma that improved after stopping the topical steroid,²⁰ an additional case developed persistent posterior subcapsular cataract,¹⁴ and another case was complicated with persistent peripheral visual field defects.³⁰ In the same context, the three reported cases of retinal damage persisted for months. While a case of retinal detachment and choroidal neovascularization improved after medical treatment, a case that developed a macular hole was partially corrected surgically with a remnant persistent retinal pigment epithelium defect, and a further case of persistent retinal pigment epithelium interruption was reported (Table 2).

Table 2 Clinical Course of the Ocular Complications Induced by Intense Pulse Light/Diode Laser and the Undertaken Treatment Measures

Discussion

Ocular injury following laser or light-based devices is not an uncommon devastating complication that can be minimized by proper training and adherence to safety protocols. Investigating a legal national resource in the US identified 174 cases of litigation involving laser procedures; more than half of them were performed for hair removal. A total of 2.2% of those cases were related to ocular injuries. More than 50% of the cases were associated with a lack of informed consent, and an additional 0.5% were related to a lack of goggles.³¹ In parallel, more than three-quarters of the reported IPL-induced ocular injuries we identified were secondary to the improper use of protective eyewear.

Although all the reported cases we identified were office-based devices, home-based devices can induce a similar pattern of injuries. For illustration, Town et al³² measured 18 IPL medical and nonmedical CE devices and 36 applicator parameters; they identified up to 10% higher emitted fluence from the applicators compared to the claimed fluence by the manufacturers, and 9 out of the 18 devices exceeded the medical Class 4 laser standards (> +20%). Additionally, 65.5% of the devices they tested showed inaccurate cutoff filters by more than 20 nm, as claimed by the manufacturers. Considering the lack of strict wide-nation regulations over light-based home device manufacturing and commercial pressures, discrepancies between the measured and manufacturers’ claimed parameters are also possible for home devices. As an instance, Eadie et al³³ examined one IPL home device for ocular safety hazards, and they discovered that the retinal thermal hazard was exceeded at a fluence of 11 J/cm² and 20 cm viewing distance following firing the IPL home device they tested. It is worth mentioning that the maximum available energy from IPL home devices is between 7.5 and 30 Joules (J) delivered over a spot size of 2–6 cm² over 2.5–60 milliseconds (Ms). On the other hand, home-based laser devices such as (Tria Beauty, Dublin, CA 94568, USA) deliver up to 22 J/cm2 over a spot size of 0.79 cm² and a pulse duration of 600 ms.^1,2,7 Nevertheless, we identified the reported ocular injuries following exposure to a similar fluence range to the home devices. Moreover, the increasing reports of ocular damage following exposure to low-energy laser sources, such as toy laser pointers, warrant the hazardous possibility of such events following exposure to low-energy home-based light sources.³⁴

Interestingly, authors of a recent surveillance-based study investigated the post marketing voluntary reports of adverse events noticed following exposure to home-IPL devices, they detected 34 cases of eye pain of unknown clinical significance.³⁵ Equally concerning, we randomly searched online market engines such as Amazon.com to identify the available hair removal light-based home devices. Predictably, out of 20 randomly detected devices searched for FDA clearance at 510(k) Premarket Notification (fda.gov),³⁶ 10 market-available devices are not FDA cleared. Eight out of the 20 randomly selected devices lack supplementary goggles with the device’s package (Table 3).

Table 3 Randomly Picked Online Available Light-Based Hair Removal Home Devices Manufacturing Properties

Clinically, IPL-induced ocular injuries most commonly present with photophobia and most widely cause iris atrophy. Ocular pain, pupil irregularities, and visual disturbances are additional concerning symptoms. Early identification of the signs and symptoms is equally essential for both physicians and home device consumers to prevent further ocular damage and complications such as iris pigment flakes and subsequent glaucoma formation. Thought-provoking, in parallel with the reported laser-induced ocular injuries,³⁷ IPL-induced ocular injuries showed left-side laterality as well, which might be triggered by the patient’s position during the procedure in relation to the operator’s dominant hand.

Conclusion

Light-based home devices are widely available in the market, in most of the world, their manufacturing process is not under strict medical safety regulations, and they are widely available in the markets. The available home devices are emitting IPL or diode lasers under the control of skin contact sensors, making the manufacturers of a good number of them not supplying the package with protective eyewear. Although the ocular damage identified in our paper was reported following IPL office-based devices, home devices can induce a similar pattern of injury that might be underreported. Given the cumulative evidence of the inaccurate light energy levels delivered by different in-office and home-based systems and the reported damage following exposure to 20–24 J/cm² fluence levels, which are within the home-based device’s energy levels, the possible severe permanent consequences of the damage cannot be ignored. IPL-induced ocular damage most commonly affects the iris, causing permanent atrophy with devastating photophobia. Awareness of the ocular hazards of IPL devices must be raised, and protective eyewear should be supplied to consumers’ hands. Manufacturers should provide clear instructions on the device package regarding ocular hazards, the importance of using protective goggles, and a firm warning for consumers not to try to overcome the protective safety features of the sensors. Both practitioners and consumers must be aware of the signs and symptoms of possible ocular damage to seek prompt medical care.