Healthy meibomian glands reside in the upper and lower eyelids and secrete meibum upon blinking to protect against evaporation of tears and lubricate the ocular surface. Meibomian gland dysfunction (MGD) occurs with a disruption in the quantity and/or quality of lipids released from the meibomian glands. Stasis of meibum promotes proliferation of bacteria, which in turn causes hyperkeratinization of meibomian gland glands and an increased melting temperature of the meibum. Less meibum is therefore released onto the ocular surface, and thus the self-propagating vicious cycle ensues (Figure 1).2 The cycle of MGD also enters the vicious cycle of Dry Eye Disease (DED), for which MGD is a well-known risk factor (Figure 2).2
“The International Workshop on Meibomian Gland Dysfunction Definition (2011): “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.”
MGD is a result of many risk factors such as age, sex, hormones, and medications, and is the most common cause of evaporative DED.3 The prevalence of MGD varies between 3.5%-70% in certain populations3 and the incidence increases with age, specifically >50 years.4 Recent studies, however, have demonstrated changes in meibomian gland atrophy as young as four years of age.5
A low delivery state of meibum is typically categorized as hyposecretory (gland atrophy) or obstructive MGD (non-cicatricial or cicatricial); conversely, a high delivery state of meibum is known as hypersecretory and is characterized by excessive release of meibum onto the ocular surface.
Eyelid hygiene is the mainstay treatment of MGD, traditionally in the form of at-home warm compresses. Heat therapy softens the meibum in the meibomian glands, thereby facilitating the replenishment of the lipid layer of the tear film and assisting in lubricating the ocular surface and stabilizing the tear film. Challenges with warm compresses arise as the melting point of obstructed meibomian glands is optimal >40°C, which may be difficult to reach with an at-home warm compress. The compress must also be applied for at least four minutes with frequent exchange of warm compress for constant effect and may be impractical for some patients.6
An additional consideration is that warm compresses alone do not evacuate glands; rather, they serve only to soften the meibum.7 Recent thinking is that at-home warm compresses are therefore best utilized as an adjunctive therapy rather than primary. Several in-office treatments are now available to assist in meibomian gland warming and evacuation, including LipiFlow (Johnson and Johnson Vision), TearCare (Sight Sciences), Systane iLux (Alcon), Miboflo Thermoflo (MiBo Medical Group), and Thermal 1-Touch (OcuSoft).
A thorough understanding of the pathophysiology of MGD can assist us as eyecare practitioners in guiding our treatment protocols and selecting which mode of treatment is best for our patients.
Keep reading for our overview of the in-office thermal pulsation treatments currently available.
TearScience Lipiflow Thermal Pulsation System (Johnson and Johnson Vision)
The FDA-approved LipiFlow Thermal Pulsation System consists of a sterile, single-use disposable activator and a console that regulates heat and pressure applied to the eyelids to liquify and evacuate meibum from the glands. The activator is designed to vault the cornea, and aside from an initial drop of topical anesthetic, no further therapeutics are needed during the procedure.
The entire procedure lasts for two cycles, 12 minutes total. The first cycle is composed of 4 minutes of regulated heat at 42.5°C, and maintains this heat throughout the entire 12 minute procedure. Once at therapeutic temperature, the pressure sensors activate to apply 5.2psi pressure to the meibomian glands. This cycle repeats once more for a total of 12 minutes.
One single Lipiflow procedure is equally efficacious as warm compresses applied twice a day for three months in improving symptoms and meibomian gland function and these results are sustained for 12 months after just one treatment.7 Additionally, the procedure increases soft contact lens tolerance by an additional four hours in patients with concurrent MGD and DED.8
Pros:
- Performs simultaneous warming and evacuation
- Heats posterior surface of lids
- Automated
- Calibrated heat and pressure
Cons:
- Large footprint
- Not easily mobile
- Not amenable to small lid apertures
- No adjustable/customized treatment
TearCare (Sight Sciences)
TearCare is a blink-assisted warming device that delivers heat to the meibomian glands. The sterile, disposable wearable elements are attached to a small, portable heating hub that delivers 45°C of heat to the eyelids for 15 minutes. The heat temperature is adjustable, and patients can keep their eyes open throughout the entire time. Within three minutes after the heating session, meibum clearance is performed manually with a clearance tool, allowing the clinician to spend as much time as is necessary to evacuate the meibomian glands. Each of the four eyelids are compressed individually, one section at a time.
When compared with at-home warm compresses twice a day for four weeks, TearCare was superior in improving tear break up time one month after the procedure. A second procedure at six months was found to be beneficial in improving signs and symptoms of MGD and DED9. Initial results of the OLYMPIA trial, which compared TearCare to LipiFlow, showed that 76% of females noted improvement in symptoms after one month, compared to 56% of females who received Lipiflow.10
Pros:
- Adjustable temperature
- customized treatments
- “Open eye” experience
- Portable, little footprint
- Amenable to any lid aperture size
Cons:
- Limited time between warming session and evacuation (3 minutes)
- Total treatment time is >20 minutes
- Outer surface heat only
- Dependent upon manual evacuation of glands
Systane iLux (Alcon)
The iLux MGD Treatment System is an FDA-approved, handheld warming and evacuation device for the treatment of MGD. It works by simultaneously applying LED-based heat and pressure to a localized area of each eyelid. A sterile, disposable tip makes direct contact with the inner and outer surfaces of the eyelid, and the device maintains a temperature of 38-42°C. The treatment takes 8-12 minutes total.
Meibomian glands that are difficult to express can be re-treated and the device allows direct visualization of glands being expressed for target areas. Tear break up time and expressibility of the meibomian glands has been shown to improve in 4 weeks, and treatment with iLux has been shown to be non-inferior to the Lipiflow System.11
Pros:
- Adjustable temperature
- Portable, little footprint
- Not limited by aperture size
- Customized treatment
- Immediate re-treatment for difficult areas
- Direct visualization of glands being expressed
Cons:
- Handheld, susceptible to those with hand tremors/arthritis
- Difficult to maneuver around patient
- Requires doctor or technician engagement throughout entire procedure
- Outer surface heat only
Mibo ThermoFlo (MiBo Medical Group)
The Mibo Thermoflo device consists of a small, portable console and handheld tip. The device delivers heat to the outer surface of the eyelids at 42.5°C, penetrating to the meibomian glands to soften meibum. The temperature is adjustable for patient comfort. Ultrasound gel is applied to the heating tip to allow it to move easily across the eyelids for a gentle massage to the meibomian glands. Two tips are available for ease of use, the more recent tip allowing a larger surface area of coverage and less movement. The heat treatment is completed in 12 minutes.
Both eyes can be performed at the same time with an updated version of the device. Manual gland evacuation must then be performed. Patients reported immediate symptomatic relief after the procedure and expressibility of the meibomian glands also improved.12 Re-treatment is often necessary; manufacturer recommendations are three treatments, two weeks apart.
Pros:
- No consumables
- Small console, small footprint
- Single/Dual heating tip available
- Adjustable temperature
- No anesthesia required
Cons:
- No localized treatment
- Outer surface heat only
- Increased patient visits for therapeutic effect
- Dependent upon manual evacuation of glands
Thermal 1-Touch (OcuSoft)
The Thermal 1-Touch device delivers constant heat and gentle pressure to the outer surface of the eyelids. Different temperature and time-to-treatment settings allow a customizable approach to heat application, varying from 39-44°C and 10-30 minutes, respectively. All four eyelids are heated simultaneously. Manual gland evacuation must be performed following heat treatment with the Mastrota meibomian paddle that comes with the kit.
Pros
- Lower cost
- Simultaneous treatment to both eyes
- Portable, little footprint
- Adjustable heat and time of treatment
Cons
- Dependent upon manual evacuation of glands
- Lacks data/comparison to other leading in-office treatments
- Outer surface heat only
Thermal pulsation devices at a glance
| Both eyes | Adjustable temperature | Automated Heat Application | Automated Pressure Application | Easily Portable | Consumables | Anesthesia Required | |
|---|---|---|---|---|---|---|---|
| Lipiflow | X | X | X | X | X | ||
| TearCare | X | X | X | X | X | ||
| iLux | X | X | X | X | X | ||
| Mibo | X | X | X | X | |||
| Thermal 1-Touch | X | X | X | X |
Overall, in-office thermal pulsation has shown to be effective in reducing signs and symptoms of MGD and DED. Treatment of MGD is often only one component of the causes of DED and should be used in conjunction with other treatments such as microblepharoexfoliation, omega 3 fatty acid supplementation; and followed up with at-home, adjunctive lid hygiene.
References:
- Nichols et al. The International Workshop on Meibomian Gland Dysfunction: Executive Summary. Investigative Ophthalmology & Visual Science March 2011, Vol.52,1922-1929.
- Baudouin C, Messmer EM, Aragona P, Geerling G, Akova YA, Benítez-del-Castillo J, Boboridis KG, Merayo-Lloves J, Rolando M, Labetoulle M. Revisiting the vicious circle of dry eye disease: a focus on the pathophysiology of meibomian gland dysfunction. Br J Ophthalmol. 2016 Mar;100(3):300-6.
- Schaumberg DA, Nichols JJ, Papas EB, Tong L, Uchino M, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on the epidemiology of, and associated risk factors for, MGD. Invest Ophthalmol Vis Sci. 2011;52(4):1994-2005.
- Den S, Shimizu K, Ikeda T, Tsubota K, Shimmura S, Shimazaki J. Association between meibomian gland changes and aging, sex, or tear function. Cornea. 2006 Jul;25(6):651-5
- Gupta PK, Stevens MN, Kashyap N, Priestley Y. Prevalence of Meibomian Gland Atrophy in a Pediatric Population. Cornea. 2018 Apr;37(4):426-430.
- Blackie CA, Solomon JD, Greiner JV, et al. Inner eyelid surface temperature as a function of warm compress methodology. Optom Vis Sci. 2008;85(8):675-683
- Blackie CA, Coleman CA, Holland EJ. The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye. Clin Ophthalmol. 2016 Jul 26;10:1385-96
- Blackie CA, Coleman CA, Nichols KK, et al. A single vectored thermal pulsation treatment for meibomian gland dysfunction increases mean comfortable contact lens wearing time by approximately 4 hours per day. Clin Ophthalmol. 2018;12:169-183.
- Badawi D. TearCare® system extension study: evaluation of the safety, effectiveness, and durability through 12 months of a second TearCare® treatment on subjects with dry eye disease. Clin Ophthalmol. 2019 Jan 22;13:189-198.
- OLYMPIA study were presented in May 2020 at the American Society of Cataract Refractive Surgery (ASCRS) Virtual Annual Meeting by Dr. Loh
- Tauber J, Owen J, Bloomenstein M, Hovanesian J, Bullimore MA. Comparison of the iLUX and the LipiFlow for the Treatment of Meibomian Gland Dysfunction and Symptoms: A Randomized Clinical Trial. Clin Ophthalmol. 2020;14:405-418.
- Charles G Connor; Srihari Narayanan; William L Miller. Abstract presented at ARVO 2016. The efficacy of MiBo Thermoflo in treatment of meibomian gland dysfunction
