Application of colored filters in patients post-traumatic brain injury: A review

Abstract

BACKGROUND:

Tinted lenses have been used to manage visual discomfort and photosensitivity in patients with migraines, benign essential blepharospasm (BEB) and epilepsy.

OBJECTIVES:

The purpose of this review is to examine the existing clinical research regarding the use of colored filters among patients recovering from traumatic brain injuries.

METHODS:

A review of English articles from PubMed, Embase from embase.com, Web of Science, APA PsycINFO (OVID), Scopus, and Cochrane Central Register of Controlled Trials with publication years from date of inception to June 10, 2021 was performed. Articles were first screened by title and abstract, followed by full-text review. The search strategy resulted in 7819 results. The final analysis included seven articles which discussed the use of tinted lenses in patients post-traumatic brain injury.

RESULTS:

While there is a paucity of information related to the therapeutic use of tinted lenses to mitigate post-traumatic light sensitivity and migraines, patients will subjectively report improved symptoms, specifically with precision tints or FL-41.

CONCLUSION:

Further studies are needed to understand the mechanism of action as well as objective and subjective benefits of tinted lenses in patient post-traumatic brain injury.

Keywords

Light sensitivity photophobia traumatic brain injury tinted lenses chromatic filters FL-41 concussion blue-light

1 Introduction

Following a traumatic brain injury (TBI), patients can suffer from a myriad of symptoms with headaches being among the most common post-traumatic symptom. Visually, symptoms can include blurry vision, photosensitivity, vergence and accommodative dysfunction, saccadic and pursuit deficiency, and visual motion sensitivity.

Migraines occur in 15.3% of the US population (Burch et al., 2018) with 400,000 people developing post-traumatic headache annually (Erickson et al., 2010). Amongst migraine sufferers, photosensitivity is a common complaint. Similarly, photosensitivity also occurs in around 50% of patients with TBI (Magones et al., 2013). Patients with light sensitivity will report symptom provocation in even normal lighting conditions, causing them to perform their daily activities in dimly lit rooms or while wearing sunglasses indoors. Photosensitivity can negatively impact activities such as watching television and working in front of a computer screen or multiple digital devices, which is a requirement for most professions nowadays (Berthold-Lindstedt et al., 2017). As the symptom of light sensitivity is seen both post-traumatically and in correlation with migraines which can occur post-traumatically, the application of tinted filters will be discussed in both conditions.

Patients with migraines (Good et al., 1991; Evans et al., 2002; Wilkins et al., 2002; Hoggan et al., 2017; Huang et al., 2011; Vieira et al., 2020) epilepsy (Wilkins et al., 1999), multiple sclerosis, and benign essential blepharospasm (BEB) (Blackburn et al., 2009; Herz & Yen, 2005) have been shown to benefit from colored filters and lenses. The use of tints in the management of visual disorders is also well established. Spectral filters have been shown to be effective in subjectively reducing glare sensitivity and photosensitivity in patients with visual impairments (Eperjesi et al., 2002; Rosenblaum et al., 2000), as well as improving contrast sensitivity associated with diabetic retinopathy (Sadeghpour et al., 2015). Red and magenta tints have been particularly beneficial in decreasing subjective photosensitivity in patients with cone dystrophies, both in spectacle and contact lens formats (Park, Sunness 2004; Rajak et al., 2006). This study aims to examine clinical research regarding the use of colored filters among patients recovering from traumatic brain injury.

2 Methods

The following literature databases were searched on June 10, 2021: PubMed, Embase from embase.com, Web of Science, APA PsycINFO (OVID), Scopus, and Cochrane Central Register of Controlled Trials. The search strategy can be seen in Table 1. The authors used Covidence to organize their review process. Duplicate articles were removed immediately after importing citations to Covidence. One author (S.B.) performed a title and abstract review. Irrelevant articles were excluded after the first review. The same author completed the full-text review. Review articles, systematic reviews, and abstracts were excluded. The authors included papers that were researching the use of tinted lenses in patients presenting with photosensitivity and associated visual symptoms secondary to traumatic brain injury. Three case studies were included in the review. While systematic reviews and meta-analyses provide the highest level of evidence, case studies provide insight into potential treatment options, especially for patient populations that typically require highly individualized treatment plans. All reviewed papers are in English. The authors also searched references from included articles for additional pertinent references. Given the design of this paper, informed consent and an Institutional Review Board process were not required.

Table 1
Search strategy

Search: “Photophobia”[Mesh] or “Phototherapy”[Mesh] OR “photophobia”[tw] or “photodysphoria”[tw] or “color lens^”[tw] or “colored lens^”[tw] or “color filter^”[tw] or “colored filter^”[tw] or “color glass^”[tw] or “colored glass^”[tw] or “color overlay”[tw] or “colored overlay”[tw] or “coloured lens^”[tw] or “colour lens^”[tw] or “colour filter^”[tw] or “coloured filter^”[tw] or “colour glass^”[tw] or “coloured glass^”[tw] or “colour overlay”[tw] or “coloured overlay”[tw] or “tinted filter^”[tw] or “tinted glass^”[tw] or “tinted lens^”[tw] or “tinted contact len^”[tw] or “phototherap^”[tw] or “light sensitivit^”[tw] or “photosensitivit^”[tw] or “light therap^”[tw] or “color therap^”[tw] or “colored therap^”[tw] or “coloured therap^”[tw] or “colour therap^”[tw] or “chromotherap^”[tw] or “color light”[tw] or “colored light”[tw] or “colour light”[tw] or “coloured light”[tw] or “precision tints”[tw] or “spectral filter^”[tw] or “blue light”[tw] or “blue tint^”[tw] or “blue blocker^”[tw] or “rose tint^”[tw] or “fl-41^”[tw]

Search: “Brain Concussion”[Mesh] or “Migraine Disorders”[Mesh] or “traumatic brain injur^”[tw] or “posttraumatic brain injur^”[tw] or “post concussive”[tw] or “concussion^”[tw] or “commotio”[tw] or “hemicrani^”[tw] or “migrain^*”[tw]

3 Results

Figure 1 illustrates the literature search process. The search strategy resulted in 7819 papers. After careful review, six papers were included from the literature search. One paper was discovered during a gray literature search or manual review. For the final review, we included seven articles for tinted lenses in patients post-traumatic brain injury (Table 2). Participant ages ranged from fourteen years to sixty years. Although there are minimal objective improvements in oculomotor findings, most patients report a subjective improvement in visual comfort, and decreased headaches and photosensitivity. Trialing different colored lenses or using an instrument, such as the Intuitive Colorimeter, can help determine the optimal chromatic filter.

Fig. 1

PRISMA diagram outlining literature review.

Table 2

Tinted lenses in patient’s post-traumatic brain injury

Study	Participants	Interventions	Study Outcomes
(Jackowski & Turk, 1996)	•7 patients post-TBI (age 29 to 42 years) and 0.4 to 10.5 years after injury •7 control patients (age 24 to 48 years)	•Trial three different Corning Photochromic Filters: CPF 450 CPF 527-S CPF 550-S •Compare contrast sensitivity (CS: Pelli-Robson Letter CS Chart) and reading rate before and after CPF	•Patients post-TBI have normal CS and decreased reading rates (compared to normal patients) •When treated with CPF, patients post-TBI demonstrate enhanced CS and increased reading rate •Most patients showed improvement with CPF 450
(Richman et al., 2007)	•A 47-year-old female suffered a concussion 5 years prior to being seen •Symptoms included: photophobia, blurry vision, movement of print, nausea and dizziness when reading	•Colored Intuitive Overlays were trialed •There are 20 different colored overlays; the colors range from yellows, pinks, purples, and blues •The patient subjectively determines which colored overlay, over a sample of text, minimizes their symptoms •Oculomotor testing was repeated with and without the colored filter	•The patient was prescribed blue tinted clip-on lenses which matched the luminance characteristics of the blue colored overlay •She reported improved reading comfort and efficiency while wearing the tinted lenses •The tinted lens also decreased the following symptoms: reading fatigue, headaches, vertigo, and photophobia •Patient performance on oculomotor tasks improved while wearing the tinted lenses (during initial testing and at her 1-month follow-up appointment)
(Lynch et al., 2015)	Patient 1 •A 14-year-old female suffered two concussions in the same week •Symptoms included: diplopia, photophobia, nausea, headache, and confusion that lasted a couple of minutes •Headache and photophobia remained persistent Patient 2 •A 15-year-old male suffered a concussion •Symptoms included: persistent headache, eye fatigue, and difficulty reading	•Computer gaming glasses were recommended 1-year post-injury •Brand of glasses: Gunnar Optiks •The gaming glasses have an amber tint that filters from nearly 100% of blue light at 400 nm to 45% of blue light at 450 nm	Patient 1 •Decreased symptoms of headaches and photophobia while wearing the glasses •Improved academic performance •Cleared to participate in sports-related activities Patient 2 •Decreased symptoms related to headache, eye fatigue, and difficulty reading •Cleared to participate in sports-related activities
(Fimreite et al., 2016)	•12 patients post-TBI (age 21 to 60 years) and were > 6 to 9 months post-injury •12 control patients (age 21–26 years)	•Five different test conditions/lenses: Gray/neutral density (uniform transmission) Blue (425 nm) Red (650 nm) Precision tint lens (PT) No lens (baseline)	•Number of fixations, number of regressions, and fixation duration: no effect on filter type •VEP amplitude and VEP latency: no effect on filter type •Reading rate: significant difference in reading rate: difference between normal subjects with the blue and the red filters, and those with mTBI using either the red, neutral density, or PT filters •Most patients selected the PT lens, despite similar objective findings through the different test conditions/filters
(Truong et al., 2014)	•62 patients post-mTBI^* •Majority were adults: 18 to 40 years •Time since injury: 2 months to 18 years	•Retrospective study •Three clinical questions: 1) Natural history of photosensitivity (PS) 2) Factors associated with changes in PS 3) Evaluate the success of PS treatments	•Changes in photosensitivity occurred after the first-year post-injury in 50% of individuals •71% of individuals who did not wear tinted lenses reported a decrease in PS •36% of individuals who wore tinted lenses reported a decrease in PS •72% of individuals wearing contact lenses (CL) reported a decrease in PS •43% of individuals not wearing CLs reported a decrease in PS •Factors associated with inhibiting PS reduction include dry eye, migraines, hyperacusis, and loss of consciousness (LOC) at the time of injury •Consider decreasing/titrating the tint density over time
(Clark et al., 2017)	•39 patients with visual symptoms included in analysis •Mean age: 32.4±16.9 years •76% of patients demonstrated photophobia	•Trial different colored glasses and shine light into each eye •Categorize symptoms of photophobia while wearing the glasses: better, worse, or the same •Allow the patient to participate in ADLs^** while wearing the colored glasses that provided some relief	•The following colors provided the most relief: Blue (45%) Green (30%) Red (27%) Purple (27%) •Patients may benefit from multiple color options
(Liu et al., 2020)	•A 28-year-old professional female with a history of multiple concussions •Her last two concussions resulted in the following symptoms: headaches, visual snow (VS), palinopsia, photosensitivity, vertical diplopia when fatigued, difficulty with near work, intermittent blurry vision, visual motion sensitivity, and dizziness	Three treatment modalities: Neuro-optometric rehabilitation therapy (NORT) Optometric phototherapy (syntonics) Chromatic filtration	•Discontinued NORT as it increased levels of nausea and dizziness •Mild reduction in symptoms with optometric phototherapy; this treatment modality ended after 10 sessions •Intuitive Colorimeter was used to prescribe a dark green tint (patient preference); the tinted lens successfully decreased the following symptoms: visual snow, palinopsia, visual motion sensitivity, photosensitivity, dizziness, balance difficulties, and eye strain; overall improvement in visual comfort •In addition to the tinted lenses, workplace recommendations included display modification of digital devices (e.g. iPHONE, iPAD)

^*Mild traumatic brain injury. ^**Activities of daily living.

4 Discussion

4.1 Traumatic brain injury

Patients suffering from photosensitivity and associated symptoms post-traumatic brain injury will often wear sunglasses indoors and outdoors, and maintain low levels of ambient indoor lighting. This type of behavior should be discouraged since chronic use of darkly tinted lenses indoors and darkened rooms can delay recovery of photosensitivity and further worsen symptoms of pain and visual discomfort with light. A study by Du et al. (2005) found that patients with light sensitivity post-TBI demonstrated elevated dark adaptation thresholds. Dark adaptation is defined as the “process by which the visual system maintains a constant level of light sensitivity in the presence of variations in ambient illumination” (Du et al., 2005). Another study by Chang et al. (2007) found elevated critical flicker fusion frequency (CFF) in light sensitive patients post-TBI. CFF is defined as “the lowest frequency at which a physically flickering light is perceived to be non-flickering or ‘steady” (Chang et al., 2007). This has important clinical and lifestyle implications as photosensitive patients post-TBI may perceive flickering in overhead lighting, particularly fluorescent or LED lighting which have a higher critical flicker function than traditional incandescent light bulbs. This increased sensitivity to flickering leads to avoidance of public places such as supermarkets and exacerbation of symptoms in areas such as workplaces. Contributing factors to photosensitivity must be managed before discussing the use of chromatic lenses. This includes, but is not limited to, anterior segment disease such as dry eye, conjunctivitis, blepharitis, meibomian gland dysfunction, pterygium, and corneal abnormalities. (Rakoczy et al., 2015). Additional posterior segment disorders which may be contributing factors include posterior inflammatory conditions such as uveitis and vitritis, photoreceptor dysfunction, retinal dystrophies, and optic neuropathies (Digre & Brennan, 2012). Associated comorbidities, such as migraines, should be managed by a neurologist or headache specialist. If a patient continues to report subjective symptoms of light sensitivity, tinted lenses are a viable treatment option. As noted in our results section, most patients reported a subjective improvement in visual comfort and decreased light sensitivity while wearing chromatic lenses. Guidelines suggest a 35% tint intensity for indoor use and 85% to 90% tint intensity for outdoor use (Kapoor & Ciuffreda, 2002). Tint color is often based on patient preference. As patients begin to report increased tolerance to light, tint density should be decreased over time to facilitate the adaptive neural process to normal lighting conditions (Truong et al., 2014). Continued wear of darkly tinted lenses indoors can inhibit this adaptive neural process. While tinted lenses provide immediate relief, patients are encouraged to function without tinted lenses as tolerated in order to minimize their dependence upon the tints, with a goal of eventual discontinuation of tinted lens wear indoors. Polarized sunglasses are strongly encouraged for outdoor wear to reduce glare.

4.2 Migraines and light sensitivity

Migraine headaches can be triggered by visual stimuli (Evans et al., 2002). Eighty to ninety percent of patients with migraines will complain of photophobia (Wu & Hallett, 2017). Given the severity of symptoms, patients will often stay in a darkened room and avoid all social, academic, and/or work-related activities. Good et al. (1991) compared FL-41 tinted glasses versus density matched blue-tinted lenses in children between eight to fourteen years of age with migraine. The tinted lenses were worn for at least eight hours per day. They found that the FL-41 tint decreased the frequency of migraine attacks after four months of daily wear but there was no change in attack duration and intensity (Good et al., 1991). After four months of daily wear, no improvement in headache frequency was observed with the blue tinted lenses (Good et al., 1991). Another study evaluated the application of an optical notch filter based on “thin-film” technology that minimizes the transmission of light at 480 nm in patients with chronic migraine (Hoggan et al., 2017). In this twelve-week study, each subject completed a four-week “pre-washout” period prior to wearing either lens to determine baseline headache characteristics (Hoggan et al., 2017). Subjects were then randomized to wear the 480 nm notch filter or 620 nm notch filter (“sham lens”) for two weeks followed by a two-week washout period of wearing no lens (Hoggan et al., 2017). After the two-week washout, subjects crossed over to wear the other lens for two weeks followed by another washout period for two weeks (Hoggan et al., 2017). This study found statistically and clinically significant score reductions on the Headache Impact Test (HIT-6) while wearing either notch filter (Hoggan et al., 2017). In a double-masked randomized controlled study with cross-over design, Wilkins et al. (2002) studied the use of an “optimal” lens tint versus “control” lens tint in seventeen subjects (mean age = 44 years). The “optimal” tint was determined using the Intuitive Colorimeter. Subjects wore each tint color in random order for six weeks, separated by a two-week washout period (Wilkins et al., 2002). Subjects maintained a daily headache diary for the duration of the study. Compared to the “control” tint, headache frequency was marginally lower when subjects wore the “optimal” tint (Wilkins et al., 2002). While it is beyond the scope of this paper, a neurological basis for the use of precision ophthalmic tints in patients with migraines is discussed by Huang et al. (2011).

4.3 Other clinical applications of chromatic lenses

While the literature regarding chromatic lenses for post traumatic photosensitivity is limited, there is evidence for the benefits of these lenses amongst other medical conditions, including but not limited to, benign essential blepharospasm and epilepsy. Reviewing the methods for appropriate tint color determination and associated symptom reduction in other patient populations with photosensitivity can provide additional insights into managing patients post-TBI.

4.4 Benign Essential Blepharospasm (BEB)

Photophobia is a common symptom for patients with BEB. Symptoms can occur in both ambient lighting and bright light (Wu & Hallett, 2017). Chromatic lenses, specifically Fluorescent-41 (FL-41), have been shown to improve symptoms of photophobia in patients with BEB. In one study, four different chromatic tints were found to help patients with BEB tolerate significantly higher levels of light intensity: Designed Spectrum 550, Designed Spectrum 600, Designed Spectrum 4/5/6, and FL-41 (Herz & Yen, 2005). Although Designed Spectrum 4/5/6 allowed patients to tolerate the highest intensity of light, the preferred lens was FL-41 (Herz & Yen, 2005). In another study, patients with BEB reported a subjective improvement in their activities of daily living (ADLs), light sensitivity, and blepharospasm frequency and severity with FL-41 chromatic lenses compared to gray-tinted lenses (Blackburn et al., 2009). While wearing FL-41 tinted lenses, objective findings using electromyography found decreased mean blink rate and blink force in patients with BEB, compared to rose-tinted lenses (Blackburn et al., 2009). Compared to the gray tint, patients with BEB were found to have reduced mean blink rate while wearing the FL-41 lenses (Blackburn et al., 2009).

4.5 Epilepsy

Patients with “pure photosensitive epilepsy” suffer from seizures that are predominantly visually induced (Covanis et al., 2014). Certain types of patterns, such as stripes, and light are known to provoke seizures (Covanis et al., 2014). Wilkens et al. (1999) evaluated 33 patients (12–43 years of age) with photosensitive epilepsy for tinted glasses using the intuitive colorimeter. Rose, blue, or purple were the preferred tint colors (Wilkens et al., 1999). Approximately 2.4 years later, thirteen patients reported continued use of the tinted lenses (17 patients were available for follow-up). (Wilkens et al., 1999). Patients subjectively reported decreased dizziness from fluorescent lighting, aura elimination during computer use, or a reduction in seizures while wearing the tinted lenses (Wilkens et al., 1999).

4.6 Tint determination

The Intuitive Colorimeter was developed by Arnold Wilkins (Wilkins et al., 2010). This device can be used to subjectively determine the patient’s specific tint color of individual choice (Wilkins et al., 2007). The patient views an illuminated page of text while manipulating hue, saturation, and luminance (Wilkins et al., 2010). Once the tint color has been determined, the patient can trial the chromatic lenses with activities that provoke symptoms, such as with reading or using digital devices. Since that time much literature has been produced demonstrating the benefits of colored filters in the management of both systemic and ocular conditions.

Many clinics do not have a colorimeter to work with but are still tasked with helping patients who suffer from photosensitivity post-concussion. In these instances, pre-made tinted lenses can be used to demonstrate a variety of spectral filters. A particularly popular option is the NORA Polytrauma filter kit which was developed by neuro-rehabilitative optometrists in the Neuro-Optometric Rehabilitation (NORA) Association and Veterans Administration organizations to combine the most frequently used Chadwick ® filters into one kit. It can be seen in Fig. 2 and includes FL-41 as well as blue, blue-green and NOIR options.

Fig. 2

NORA Poly Trauma Filter Kit from Chadwick Optical.

FL-41 (Fig. 3) is a popular tint color, both for prescribing physicians and patients. FL-41 lenses minimize transmission of shorter wavelengths, around 480 nm (Diel et al., 2020; Katz & Digre, 2016). This wavelength of light has been shown to maximally stimulate the intrinsically photosensitive retinal ganglion cells (IPRGC) which can activate the trigeminothalamic or pain pathways (Diel et al., 2020; Katz & Digre, 2016). A custom lighter FL-41 tint can be used for indoor wear while a darker tint may be worn outdoors (Fig. 4). FL-41 tinted lenses can be ordered through many lens companies including TheraSpecs, Eschenbach, and Axon Optics.

Fig. 3

FL-41 tinted lenses from TheraSpecs (left: standard indoor tint; right: standard outdoor tint).

Fig. 4

Custom FL-41 tinted lenses from TheraSpecs (top: custom light 35%; bottom: custom dark tint 76%).

4.7 Additional lens modalities – contact lenses

An additional option for patients who wear contact lenses would be to place the tint within the contacts. While there is not much literature on this yet, there are case reports demonstrating the benefits of this approach. Specialty prosthetic tinted contact lenses in colors similar to those traditionally used with patients post-TBI can be found through Orion Vision Group and Axon Optics.

4.8 Blue light-blocking lenses

Blue-light blocking lenses have gained immense popularity, especially in recent years. Blue light, wavelengths between 400–500 nm, appear in all aspects of modern life from sunlight to LEDs and the screens of commercial electronic devices (Rosenfeld, 2019). While there is concern that blue light may cause photochemical damage to the retina and exacerbate symptoms of eye strain, blue light is necessary for color discrimination, night vision, and regulation of the pupillary light reflex and the circadian rhythm (Leung et al., 2017). A review by Lawrenson et al. (2017) found there is a lack of high-quality clinical evidence supporting the benefits of blue-light blocking lenses. A double-masked randomized controlled clinical trial found little benefit of blue-light blocking lenses compared to clear (placebo) lenses on eye-strain after two hours of computer use (Singh et al., 2021). Another randomized controlled trial found little improvement in objective and subjective total sleep time when comparing blue-light blocking lenses and clear lenses in healthy adults (Bigalke et al., 2021). This crossover study design required participants to wear the lenses from 6 PM until bedtime for seven consecutive days (Bigalke et al., 2021). Despite limited evidence and benefits on the evening use of blue-blocking lenses, caution should be given for overall recommendations to wear blue-blocking lenses all day. Morning blue light therapy (BLT) and exposure has been shown to reduce cognitive fatigue and improve sleep in patient’s post-traumatic brain injury. Raikes et al. (2021) randomly assigned 62 participants, from two different cities, to 30 minutes of morning BLT or placebo amber light therapy (ALT). After six weeks of light therapy, participants in the BLT group were found to have increased gray matter volume and functional connectivity, particularly in the areas associated with decreased daytime sleepiness and improved cognitive function (Killgore et al., 2020; Raikes et al., 2021). A similar study by Salva et al. (2019) found reduced levels of fatigue after four weeks of morning blue-enriched white light therapy in patients with severe TBI. Further clinical trials are needed to better evaluate the application of blue-light blocking lenses and morning blue light exposure in patients post-traumatic brain injury.

4.9 Additional accommodations

If the patient is unable to wear colored lenses, the following workplace accommodations to minimize light sensitivity and increase visual comfort are recommended (Apple Support Page):

Anti-glare screens for computer monitors and/or anti-glare lens coatings

Minimize overhead fluorescent lighting and/or wearing a brimmed hat

Adjust display and text size preferences digital devices

Invert colors: view items against a dark background (Fig. 5)

Turn on color filters (Fig. 6)

Additional accommodations under “Display and Text Size screen”

Increase text size

Reduce white point: decreases the intensity of bright colors

Fig. 5

How to Invert colors with iOS devices.

Fig. 6

Adjusting color filters with iOS devices.

5 Conclusion

There is a paucity of information related to the therapeutic use of tinted lenses to mitigate post-traumatic light sensitivity and migraines. While many case reports show subjective improvements in symptom levels, further studies into the mechanism of action as well as objective and subjective benefits of tinted lenses are recommended.

Tinted lenses are a relatively safe and noninvasive method for helping manage symptoms such as light sensitivity and migraine’s post-traumatic brain injury. While there are commercially available over the counter tints, many of them are too dark for indoor use. It is recommended that tinted lenses be provided and managed by eyecare providers with experience in prescribing tinted lenses as prolonged use of darker tints can inhibit neural adaptation leading to prolonged photophobia and symptoms. Additionally, it is important to evaluate and manage refractive error, ocular health (e.g. dry eye), and underlying binocular vision deficits in addition to using therapeutic tints, if indicated.

Footnotes

Acknowledgements

The authors would like to thank Lily Ren, MI, for assisting them with the literature search and Chadwick Optical and Theraspecs for product pictures.

Conflict of interest

Bausch Health US, LLC (SB): no impact on the contents of this paper.

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