Abstract
Meibomian gland dysfunction (MGD) is characterized by the obstruction and/or inflammation of the meibomian glands that result in decreased and altered meibum secretion. This results in deficiencies in the tear film lipid layer which contributes to increased evaporation and destabilization of the tear film. One of the mainstay therapies for MGD is medical devices that apply heat and/or pressure to the eyelids and promote the liquification and outflow of meibum into the tear film. Over the past two decades, there have been a surge of interest in diagnosing and managing MGD. As a result, numerous medical devices have been developed and each have their own unique approach to treating MGD. This narrative review was conducted to summarize the current state of knowledge on eyelid warming devices, specifically warm eye coverings, devices that direct heat and/or pressure to the eyelids, moisture chamber goggles, and light-based therapy. This review summarized 58 human clinical studies and found that most eyelid warming devices were efficacious in improving signs and symptoms in a wide range of MGD severities and were generally safe to use.
Introduction
Defined by The Tear Film and Ocular Surface Dry Eye Workshop II (TFOS DEWS II),
Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.Citation1
Meibomian gland dysfunction (MGD) is the most common cause of dry eye diseaseCitation2 and is defined by The International Workshop on Meibomian Gland Dysfunction as
… a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion. It may result in alteration of the tear film, symptoms of eye irritation, clinically apparent inflammation, and ocular surface disease.Citation3
In a recent report, MGD was recognized by the Osmoprotection in Dry Eye disease – Expert Opinion (OCEAN) group as six separate conditions; primary obstructive keratinization of the meibomian gland, abnormal meibomian gland secretion, eyelid inflammation, corneal and conjunctival inflammation and epithelial damage, microbiological changes, and DED.Citation4
The clinical assessment of MGD involves quantifying symptoms, assessing the quality of meibum, examining the lid features and gland drop out, and examining tear film stability.Citation3 The ocular symptoms are typically burning, stinging, itching, irritation, light sensitivity and fluctuating blurred vision,Citation5 all of which could negatively impact quality of life and requires significant effort to manage.Citation6 The main outcomes are improved symptoms, meibomian gland function, and tear film stability.Citation7
The treatment of MGD involves heating the eyelids to improve meibomian gland function. Warm compresses (WC) are considered the first line of treatment for MGD.Citation7,Citation8 The temperature required to soften or liquify pathological meibum is >40℃,Citation7 whereas the melting point for normal meibum is approximately 34.0℃.Citation9 While face cloths and towels are frequent recommendations for treating MGD in clinical care, Blackie et al (n = 32) showed that towels or cloths rapidly lose heatCitation10 and took approximately 6 minutes for the inner eyelid to reach a therapeutic temperature of 40.4 ± 0.3℃. This finding was corroborated by Bitton et alCitation11 and Lacroix et al,Citation12 who also demonstrated the rapid cooling of towel compresses. It was only by using the labour intensive “Bundle method” described in Murakami et al,Citation13 where multiple towels are rolled into each other, could towels retain a sufficiently elevated temperature ≥40℃.Citation13 However, it is important to note that temperatures above 45℃ may increase the risk for thermal injury to the eye or eyelids.Citation14,Citation15 A common side-effect experienced after heat and pressure from WC treatment is a transient visual blur from changes in the structure of the corneal epithelium. The transient phenomenon is known as the polygonal reflex of Fischer-Schweitzer.Citation16,Citation17
To address the deficiencies of cloth or towel warm compresses, numerous medical devices have been developed to treat MGD by maximizing heat retention and delivery to the eyelids while improving patient and practitioner convenience. Broadly, these medical devices consist of warm eye coverings, automated, or manually operated devices that deliver heat and/or pressure to the eyelids, moisture chamber goggles, and light-based therapies. This review aims to summarize the peer-reviewed literature on these eyelid warming devices along with their efficacy, safety, and place in therapy.
Materials and Methods
An informal search on PubMed was repeatedly conducted using a combination of terms “dry eye”, “meibomian gland dysfunction”, “warm compresses”, “efficacy”, “thermal pulsation”, “intense pulsed light”, “radiofrequency”, and “moisture goggles”, “low level light”, “quantum molecular resonance”, with the last search occurring on April 27th, 2022. The search was limited to human clinical studies with no limit on publication year. A study was discarded if it did not assess clinical efficacy of treatments, were not accessible, or were not full-length research articles. The studies were sorted into five types of treatment categories: heated eye coverings, moisture chamber goggles, devices that deliver heat and pressure, intense pulsed light (IPL), and others. For each category, a brief description of the nature of the treatment is discussed, along with a summary of their clinical efficacy and adverse events associated with the use of the treatment.
Review
A total of 58 studies were deemed eligible for this review. Since some studies had examined multiple treatment types, these studies were duplicated across the different treatment modalities, giving a total of 62 studies.
There was large variability in clinical testing and reporting of study outcomes. Therefore, to provide an informative yet readable overview on clinical efficacy against MGD, we collapsed the clinical outcomes into three categories:
Improved symptoms, where participants demonstrated a statistically significant improvement in any symptom assessment metric, eg, Ocular Surface Disease Index, Standard Patient Evaluation of Eye Dry, visual analogue scores, or other surveys.
Improved tear stability, where participants demonstrated a statistically significant improvement in non-invasive or invasive tear breakup time.
Improved meibomian gland function, where participants demonstrated a statistically significant improvement in meibomian gland obstruction, meibum quality, expressibility, meibography, and lid margin features.
The clinical outcomes of each study were examined and labeled with one or more of these categories. A lack of a category assignment indicates that the study either did not use those metrics or that there were no statistically significant treatment effects related to those categories.
The distribution of the studies and a summary of their clinical efficacy across the different devices are summarized in . A comprehensive list of the studies reviewed is detailed in .
Table 1 Number of Studies per Treatment Modality
Table 2 Summary Heated Eye Coverings for the Treatment of MGD
Table 3 Summary of Moisture Chamber Goggles for the Treatment of MGD
Table 4 Summary of Devices That Deliver Heat and/or Pressure for the Treatment of MGD
Table 5 Summary of Intense Pulsed Light for the Treatment of MGD
Heated Eye Coverings
Heated eye coverings are typically employed as the first line of treatment for MGD.Citation7 They typically come in the form of a small sack or pouch containing seeds or beads that become warm when heated in the microwave oven. Alternatively, they may generate heat through a controlled chemical reaction.Citation18 Generally, they have the capability to hold a therapeutic temperature longer than towels.Citation11,Citation12 Of the 9 studies reviewed (); 78% (7/9) reported improvement in symptoms,Citation19–25 56% (5/9) reported improvement in tear stability,Citation19–21,Citation25,Citation26 and 44% (4/9) reported improvement in meibomian gland function.Citation18,Citation20,Citation21,Citation23 Only 2 studies reported adverse events,Citation18,Citation21 which were primarily related to discomfort using the devices.
Heated eye coverings are categorized under Stage 1 in the TFOS DEWS II staged management strategy,Citation2 which are treatments intended for mild MGD. The advantages of heated eye coverings are that they are relatively affordable and accessible; however, they require daily use and adherence to therapy to maintain treatment efficacy. It was reported that only 55% of patients are compliant with warm compresses and lid hygiene after six weeks of use.Citation27
Moisture Chamber Goggles
Moisture chamber goggles function by producing moist heat in an enclosed goggle system that warms the eyelids and meibomian glands. A total of 13 studies () have examined its efficacy in treating MGD, which found improved symptoms, improved tear stability, and improved meibomian gland function in 62% (8/13),Citation18,Citation25,Citation28–33 46% (6/13),Citation25,Citation26,Citation30,Citation31,Citation33,Citation34 and 8% (1/13) of studies,Citation18 respectively. There were no adverse events reported with the use of moisture chamber goggles. Of the studies reviewed, the most common device encountered was the Blephasteam, making up 8 of the studies in this section.
The Blephasteam can be tailored for use in-office or at-home.Citation35 The device consists of a goggle with disposable rings that are moistened with saline to increase humidity within the chambers.Citation35 A controller provides heat to the chambers. The treatment length is 10 minutes, during which the patient can have their eyes open or closed.Citation35 No mechanical pressure is applied to the meibomian glands.
Moisture chamber goggles are categorized under Stage 2 in the TFOS DEWS II staged management for dry eye,Citation2 targeting moderate dry eye and MGD. One advantage that moisture chamber goggles may have over heated eye coverings is the ability to retain moisture and provide consistent temperature control. However, they cost more and are not as readily accessible as heated eye coverings.
Devices That Deliver a Combination of Heat and or Pressure
A medical device applying a combination of thermal and mechanical energy to treat MGD was first described in 2011.Citation36 Applying a combination of heat and physical pressure to the eyelids promotes the liquification and expression of meibum. The most common device in the peer-reviewed literature by far is the Johnson and Johnson LipiFlow (Johnson & Johnson, FL, USA), which was represented in 17 studies in this section. Recently, treatment efficacy data for the iLux (Alcon TX, USA) and the TearCare (Sight Sciences, CA, USA) have started to emerge.
The LipiFlow directs heat to the inner eyelid while providing pulsatile mechanical pressure to the outer eyelids to facilitate the expression of the meibomian glands in an automated fashion.Citation37 The iLux is a hand-held device that uses light energy to heat the eyelids and a lever to facilitate manual expression. The device also contains a magnifier for the clinician to examine the meibomian gland orifices and expressed meibum.Citation38 The TearCare consists of a warming element that is attached to the outer eyelids to heat the eyelids. The temperature and duration of heating is controlled through a hub. However, the TearCare does not provide any mechanical pressure; therefore, any meibomian gland expression would need to be manually conducted.Citation39–42 While the LipiFlow was the first to demonstrate sustained treatment efficacy of signs and symptoms of MGD, the iLux and the TearCare each have demonstrated non-inferiority to the LipiFlow.Citation38,Citation41
Collectively, a total of 20 studies examined these heat and pressure devices for treating MGD (). An improvement in symptoms, tear stability, and meibomian gland function was reported in 95% (19/20),Citation36–54 85% (17/20),Citation36–42,Citation44,Citation45,Citation47–49,Citation51–55 and 95% (19/20) of studies,Citation36–47,Citation50–55 respectively. Of the 20 studies, 5 studies reported adverse events which were primarily related to discomfort.
In-office treatments are categorized under Stage 2 in the TFOS DEWS II staged management for dry eye,Citation2 targeted for individuals with moderate to severe dry eye and MGD. Due to the ability of these devices to sustain signs and symptoms over a long period of time, they may be suitable for patients who are non-adherent with daily warm compress treatment.
Intense Pulsed Light
IPL has been used in dermatology to treat various skin conditions such as rosacea, dyspigmentation, reducing telangiectasia, and fine wrinkles.Citation56 The delivery of non-coherent light (500 nm – 1200 nm) may treat MGD through these potential mechanisms:Citation57 the first is direct delivery of heat to the meibomian glands which serves to melt and facilitate meibum flow, the second is the photocoagulation of telangiectatic vessels along the lid margin, which reduces pro-inflammatory cytokine circulation in the area, thirdly, reduction of inflammation by reducing demodex infestation, and lastly, photomodulatory effect that alters intracellular metabolic activity of the meibomian glands.
This review found 23 studies examining the efficacy of IPL in treating MGD (). IPL improved symptoms, tear stability, and meibomian gland function in 96% (22/23),Citation58–79 87% (20/23),Citation58–66,Citation68–72,Citation74–79 and 87% (20/23) of studies reviewed,Citation58–61,Citation63–71,Citation73–79 respectively. Two studies reported adverse events related to using IPL.Citation72,Citation80 Notably, pigment in the iris absorbs light that is emitted by the IPL, therefore inappropriate eye protection while using IPL could lead to adverse events. A few case reports and reviews have documented ocular complications such as anterior uveitis, iris atrophy, pupillary defects and long-lasting pain and photophobia associated with IPL use.Citation81–83
There are various IPL systems that have been used for treating MGD and the treatment protocol can vary greatly. For example, using the Lumenis M22 (Yokneam, Israel) involves applying ~13 flashes tragus to tragus which is then repeated again in a second pass;Citation60 in contrast, the E-swin E>Eye (Houdan, France) applies 5 flashes per eye using a single pass.Citation68 Indeed, the most common systems encountered in this review were the Lumenis M22 and the E>Eye, each representing 39% (9/23) and 26% (6/23), respectively, of the studies each in this section. While the efficacy of IPL in treating MGD has been demonstrated, there are no head-to-head studies to determine which system is superior. In addition to varied protocols for energy delivery, IPL may also be combined with other therapies, such as meibomian gland expressionCitation58–61,Citation63,Citation69,Citation76 and low-level light therapy.Citation67,Citation70,Citation71
IPL is categorized under Stage 2 in the TFOS DEWS II staged management for dry eye,Citation2 and based on the severity of MGD and dry eye participants that have been enrolled in IPL trials IPL appears to be supported in the treatment of moderate to severe dry eye and MGD. Patients who do notrespond well to traditional eye warming therapy or have a history of ocular rosacea may be good candidates for IPL therapy.Citation69
Others: Low Level Light and Quantum Molecular Resonance
LLLT takes advantage of photobiomodulation, a technique that involves applying red or near infra-red radiation using low power light sources to promote tissue repair, decrease inflammation, and relieve pain.Citation84 This technology was adapted from dermatological applications for rejuvenating skin.Citation85 The mechanism of action is hypothesized to be as follows: light is absorbed by mitochondrial cytochrome c oxidase, which promotes electron transport chain activity and ATP output, leading to increased expression of transcription factors associated with cell survival and repair.Citation85 Currently, there is only one study indexed in PubMed that examines the effect of LLLT on MGD ().Citation86 Park et al (n = 40) found that there were no significant differences in outcome variables between LLLT treatment and placebo; however, there was a significant improvement in upper lid meibography in the LLLT group compared to its baseline. More rigorous studies on the clinical efficacy of LLLT on treating MGD would be valuable for determining its place in therapy.
Table 6 Other Devices for the Treatment of MGD
Quantum molecular resonance is a technique that applies high frequency, low intensity electrical currents to create magnetic fields that alter biological tissue function, which has been found to have anti-inflammatoryCitation87 and tissue regeneration properties.Citation88 This review found only one study examining the effect of quantum molecular resonance on treating MGD ().Citation89 Ferrari et al (n = 25) found that quantum molecular resonance improved symptoms, tear stability, and meibomian gland function.Citation89 As with LLLT, more studies would be valuable learn more about its treatment efficacy.
Notably, radiofrequency technology has begun to emerge as a method for treating MGD and was also adapted from dermatology aimed at rejuvenating skin.Citation90,Citation91 As of currently, there are no peer-reviewed literature indexed on PubMed examining radiofrequency and their efficacy in treating MGD in a clinical setting.
The most popular and overrepresented devices in the peer reviewed literature in each category are MGDRx EyeBag for heated eye coverings, Blephasteam for moisture chamber goggles, LipiFlow for heat and pressure, and the M22 for IPL. The reason for their popularity is speculative and may be related to the availability of the device for clinical use and research funding. However, the implication is that the efficacy summary in this paper is largely driven by each of these devices, but these devices may not be representative of the whole category. Therefore, care should be taken in the interpretation of this data.
While there is not much known about LLLT, quantum molecular resonance, and radiofrequency, it should be noted that the mechanism of action for these technologies is likely based in stimulation of tissue function as opposed to the conventional “thermal” approaches for treating MGD. Since electromagnetic therapies have a uniquely different mechanism of action, it may be possible that they could be used in conjunction with conventional thermal-based MGD treatments to yield outcomes that are superior to an individual device alone (eg, combining heat and pressure with IPL and LLLT). However, as there are currently no studies that have tested this notion, it would be valuable for future work to focus on testing the effect using complementary strategies for treating MGD. Furthermore, more work investigating the basic and clinical science of these technologies and its applications would be valuable.
Conclusion
In summary, there are a variety of eyelid warming devices in the peer-reviewed literature that address the deficiencies of the classical warm cloth/towel compress. Not only do they improve the effectiveness of delivering heat and pressure to the eyelids, they also allow for sustained clinical improvements with a single treatment. Additionally, some newer devices using light and electromagnetic therapy can directly influence meibomian gland metabolic function; however, their precise mechanism has yet to be determined.
Disclosure
Over the past three years, the Centre for Ocular Research & Education has received research funding from the following companies: Alcon, Allergan, Allied Innovations, Aurinia Pharma, Azura Pharma, Bausch Health Canada, Brien Holden Vision Institute, CooperVision, GL Chemtec, i-Med Pharma, Johnson & Johnson Vision, Lubris, Menicon, Nature’s way, Novartis, Ophtecs, Ote Pharma, PS Therapy, Santen, SightGlass, SightSage, Visioneering Tech. Dr Brandon Bzovey reports Research support to from listed companies: Alcon, Allergan, Allied Innovations, Aurinia Pharma, Azura Pharma, Bausch Health Canada, Brien Holden Vision Institute, CooperVision, GL Chemtec, i-Med Pharma, Johnson & Johnson Vision, Lubris, Menicon, Nature’s way, Novartis, Ophtecs, Ote Pharma, PS Therapy, Santen, SightGlass, SightSage, Visioneering Tech. Dr William Ngo reports Research support paid to institution from Alcon, Allergan, Allied Innovations, Aurinia Pharma, Azura Pharma, Bausch Health Canada, Brien Holden Vision Institute, CooperVision, GL Chemtec, i-Med Pharma, Johnson & Johnson Vision, Lubris, Menicon, Nature’s Way, Novartis, Ophtecs, Ote Pharma, PS Therapy, Santen, SightGlass, SightSage, Visioneering Tech, personal fees from Alcon, personal fees from Sun Pharma, outside the submitted work. The authors report no other conflicts of interest in this work.
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