Eyelid Thermal Pulsation
DESCRIPTION
Dry eye disease, dry eye syndrome, or dysfunctional tear syndrome are frequent causes of ocular irritation affecting more than seven million Americans over the age of 40. Meibomian gland dysfunction (MGD) causes changes in the secretion of the glands with or without orifice obstruction and is recognized as the most common cause of evaporative dry eye disease. MGD may also play a role in aqueous deficient dry eye. Current treatment options for MGD include warm compresses to help liquify the secretions, expression of secretions to relieve an obstruction, eyelid scrubs/hygiene, and medications (e.g., antibiotics, topical corticosteroids).
Thermal pulsation is a treatment option being investigated to treat meibomian gland dysfunction (MGD). Thermal pulsation involves heating the palpebral surfaces of the upper and lower lids while simultaneously applying graduated pulsatile pressure to the outer eyelid surface. It is designed to milk the secretions from the base of the meibomian gland to the gland orifices. The single eyelid thermal pulsation system being marketed (LipiFlow® System) was classified by the FDA in 2011 as a class II device for use in adults with chronic cystic conditions of the eyelids, including MGD.
POLICY
Eyelid thermal pulsation therapy to treat dry eye syndrome is considered investigational.
IMPORTANT REMINDERS
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ADDITIONAL INFORMATION
The data is insufficient to determine the effects of thermal pulsation on long term health outcomes. Independent trials with long term follow-up are needed to assess durability of effect.
SOURCES
American Academy of Ophthalmology Cornea/External Disease PPP Panel. (2018). Dry eye syndrome preferred practice pattern - 2018. Retrieved June 10, 2021 from http://www.aao.org/preferred-practice-pattern/dry-eye-syndrome-ppp-2013.
Baumann, A., & Cochener, B. (2014). Meibomian gland dysfunction: a comparative study of modern treatments. Journal Français d'Ophtalmologie, 37 (4), 303-312. Abstract retrieved November 14, 2016 from PubMed database.
Blackie, C. A., Coleman, C. A., & Holland, E. J. (2016). The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye. Clinical Ophthalmology, 10, 1385-1396. (Level 2 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (4:2023). Eyelid thermal pulsation for the treatment of dry eye syndrome. (9.03.29). Retrieved November 8, 2023 from www.bcbsaoca.com/eps/. (18 articles and/or guidelines reviewed)
Finis, D., Hayajneh, J., Kønig, C., Borrelli, M., Schrader, S., & Geerling, G. (2014). Evaluation of an automated thermodynamic treatment (LipiFlow®) system for meibomian gland dysfunction: a prospective, randomized, observer-masked trial. The Ocular Surface, 12 (2), 146-154. Abstract retrieved October 18, 2018 from PubMed database.
Hu, J., Zhu, S., & Liu, X. (2022). Efficacy and safety of a vectored thermal pulsation system (Lipiflow®) in the treatment of meibomian gland dysfunction: a systematic review and meta-analysis. Graef’s Archive for Clinical and Experimental Ophthalmology, 260 (1), 25-39. Abstract retrieved November 8, 2023 from PubMed database.
National Institute for Health and Care Excellence (2015, April). Medtech: LipiFlow thermal pulsation treatment for dry eyes caused by blocked meibomian glands. Retrieved October 23, 2017 from www.nice.org.
Satjawatcharaphong, P., Ge, S., & Lin, M. C. (2015). Clinical outcomes associated with thermal pulsation system treatment. Optometry and Vision Science, 92 (9), e334-e341. Abstract retrieved November 14, 2016 from PubMed database.
Schallhorn, C., Schallhorn, J., Hannan, S., & Schallhorn, S. (2017). Effectiveness of an eyelid thermal pulsation procedure to treat recalcitrant dry eye symptoms after laser vision correction. Journal of Refractory Surgery, 33 (1), 30-36. Abstract retrieved October 23, 2017 from PubMed database.
Tauber, J. (2020). A 6-Week, prospective, randomized, single-masked study of lifitegrast ophthalmic solution 5% versus thermal pulsation procedure for treatment of inflammatory meibomian gland dysfunction. Cornea, 39 (4), 403-407. Abstract retrieved June 10, 2021 from PubMed database.
Tauber, J., Owen, J., Bloomenstein, M., Hovanesian, J., & Bullimore, M.A. (2020). Comparison of the iLUX and the lipiFlow for the treatment of meibomian gland dysfunction and symptoms: A randomized clinical trial. Clinical Ophthalmology, 12 (14), 405-418. (Level 2 evidence)
U. S. Food and Drug Administration. (2011, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K112704 (LipiFlow® thermal pulsation system). Retrieved October 23, 2017 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Comparative Effectiveness Review. (2019, December; last update search May 2023). Thermal pulsation for chronic dry eye syndrome and meibomian gland dysfunction. Retrieved November 8, 2023 from www.Hayesinc.com/subscribers. (29 articles and/or guidelines reviewed)
Zhao, Y., Veerappan, A., Yeo, S., Rooney, D., Acharya, R., Tan, J., et al. (2016). Clinical trial of thermal pulsation (LipiFlow) in meibomian gland dysfunction with pre-treatment meibography. Eye & Contact Lens, 42 (6), 339-346. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 7/13/2013
MOST RECENT REVIEW DATE: 12/14/2023
ID_BA
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Keywords: Pulsed Light Therapy