This document addresses the use of devices which will automate the process of applying heat and intermittent pressure for the treatment of meibomian gland dysfunction.

Investigational and Not Medically Necessary:

The use of an automated evacuation device using heat and intermittent pressure is considered investigational and not medically necessary for the treatment of meibomian gland dysfunction.

Goto and colleagues (2002) reported on the safety and short-term efficacy of an infrared warm compression device used in 37 subjects with a diagnosis of non-inflamed meibomian gland dysfunction. Subjective symptom scores, face scores, tear evaporation rates, fluorescein and rose Bengal vital staining, tear break up time, Schirmer test, meibomian gland obstruction, and meibography were compared before and after 2 weeks of treatment. Following 2 weeks of treatment, total symptom scores improved from 12.3 to 8.4. Face scores improved from 7.0 to 5.3. Tear evaporation rates did not change significantly after treatment, but evaporation during forced blinking decreased from 22.1 to 16.2. Improvement of scores was also noted in fluorescein and Bengal vital staining, tear break up time in seconds, Schirmer test and meibomian gland obstruction. No change was noted in meibography score before or after treatment. The authors concluded that the infrared warm compression device was safe and effective for the meibomian gland dysfunction after 2 weeks of treatment. However, the treatment in this study was limited to non-inflamed meibomian gland dysfunction. The authors have no experience with this treatment for meibomian gland dysfunction with active inflammation. With a small group size and lack of a control group, the authors concluded that a long term study would be required.

In 2006 Matsumoto reported the evaluation of safety and efficacy of a warm moist air device on tear functions and meibomian gland dysfunction. In a short-term study, 15 individuals with simple meibomian gland dysfunction and 20 control individuals were enrolled to evaluate the safety and short-term effects of a warm moist air device. All individuals underwent moist warm air applications for 10 minutes. Visual analog scores were used to measure symptoms of ocular surface fatigue, changes in tear functions and ocular surface status. Tear film break-up time measurements were obtained along with Schirmer test 1, fluorescein staining scores and rose Bengal staining scores. After the initial study, another longer-term clinical trial was started. Ten individuals with simple meibomian gland dysfunction received warm moist air treatment for 2 weeks and another 10 individuals with simple meibomian gland dysfunction received warm towel compresses for 2 weeks. Treatment was performed for 10 minutes twice a day for 2 weeks. Visual analog scores, tear film break-up time measurements, fluorescein and rose Bengal staining scores were measured before and 24 hours after each treatment. Visual analog scores showed improvement with warm moist air application in the short-term study and in both the warm moist air device and warm compress application groups after 2 weeks. Tear film break-up time improved from 3.9 seconds to 10.9 seconds in the individuals with meibomian gland dysfunction with warm moist air application in the short-term study. The tear film time did not change significantly in the control group. Schirmer test, fluorescein and Bengal rose staining scores did not show significant changes with warm moist air application in the short-term study, nor did it change in the warm moist air device or warm compress groups after 2 weeks.

Friedland and colleagues (2011) reported on 14 individuals with a prior diagnosis of meibomian gland dysfunction during an open label multi-center trial where participants received a 12 minute treatment with an automated device that delivers heat and massage along the eyelids from the terminal ends of the meibomian glands to the meibomian gland orifices. Automated treatment was given to both eyes in succession. There was no control group however individuals also received additional expression on one eye only with a handheld instrument which was manipulated against the inner surface of the lower eyelid while the meibomian glands were manually expressed with the thumb or index finger. The purpose of the automated device is to soften the obstruction with heat and express the obstruction with pulsatile pressure. Subjects were evaluated at baseline and following treatment at 1 week, 1 month and 3 months. Individuals were observed for the number of meibomian glands yielding liquid secretion, tear film break-up time, corneal fluorescein staining, dry eye symptoms, and discomfort or pain during the treatment. The mean number of meibomian glands yielding liquid secretion increased from 2.9 at baseline to 9.9 at 3 months. Tear film break-up time on average increased from 5.2 seconds at baseline to 11.0 seconds at 3 months. On average, corneal fluorescein staining decreased from 0.6 seconds to 0.1 seconds at 3 months. Dry eye symptoms were measured using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. The SPEED score decreased on average from 16.2 at baseline to 7.8 at 3 months. During the automated treatment, discomfort scores were reported as 2.3-2.4 and they were reported as 3.7 during the handheld device. One individual received only 10.5 minutes of treatment with the automated device as it was stopped due to discomfort.

While initial study suggests that automated devices appear to be a safe and a promising treatment for meibomian gland dysfunction, further study is needed. Current literature is limited to small group sizes and there is inadequate published literature comparing the treatment effect of an automated evacuation device to conventional treatment with warm compresses or massage.

The meibomian glands are oil-secreting glands located within the eyelids. They are located in both the upper and lower eyelids. The ducts for the glands are located along the margin of the eyelid. They discharge an oily secretion known as sebum which lubricates the eyelids. The glands release the oil into tear film. The released oil helps to prevent the water in tears from evaporating. This helps to prevent dry eyes from occurring. If the oil becomes too thick, it can lead to a blockage of the duct which takes the oil from the gland to the tear film. The oil will continue to be made and this can lead to swelling and filling of the gland. A severe blockage can lead to enlarged glands or infection. Lack of oil in the tear film can also lead to dry eyes. An infection may require antibiotics. Conventional treatment includes unclogging the glands which are blocked. This can be accomplished by applying heat (such as a warm compress) to the eyelid and finger massage.

In June, 2011 the U.S. Food and Drug Administration (FDA) granted 510(k) marketing clearance for the LipiFlow^® Thermal Pulsation System (TearScience^®, Inc., Morrisville, NC). The device is" intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye" (FDA, 2011). The FDA clearance was based on unpublished clinical trial data supplied by the manufacturer.

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When services are Investigational and Not Medically Necessary:

Peer Reviewed Publications:

1. Friedland BR, Fleming CP, Blackie CA, Korb DR. A novel thermodynamic treatment for meibomian gland dysfunction. Curr Eye Res. 2011; 36(2):79-87.
2. Goto E, Monden Y, Takano Y, et al. Treatment of non-inflamed obstructive meibomian gland dysfunction by an infrared warm compression device. Br J Ophthalmol. 2002; 86(12):1403-1407.
3. Matsumoto Y, Dogru M, Goto E, et al. Efficacy of a new warm moist air device on tear functions of patients with simple meibomian gland dysfunction. Cornea. 2006; 25(6):644-650.
4. Romero JM, Biser SA, Perry HD, et al. Conservative treatment of meibomian gland dysfunction. Eye Contact Lens. 2004; 30(1):14-19.

Government Agency, Medical Society, and Other Authoritative Publications:

1. U.S. Food and Drug Administration 510(k) Premarket Notification Database. LipiFlow^® Thermal Pulsation System. No. K093937. Rockville, MD: FDA. June 28, 0211. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093937.pdf. Accessed on August 15, 2011.

1. National Eye Institute. U.S. National Institutes of Health. Available at: http://www.nei.nih.gov/. Accessed on July 29, 2011.

LipiFlow Thermal Pulsation System
Meibomian gland
TearScience

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