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  • AAO OTAC Oculoplastics/Orbit Panel, Hoskins Center for Quality Eye Care
    Oculoplastics/Orbit

    Abstract

    A report by the American Academy of Ophthalmology Ophthalmic Technology Assessment Committee Oculoplastics and Orbit Panel

    Jeremiah P. Tao, MD;1 Joanne F. Shen, MD;2 Vinay K. Aakalu, MD, MPH;3 Jill A. Foster, MD, FACS;4 Suzanne K. Freitag, MD;5 Timothy J. McCulley, MD;6 M. Reza Vagefi, MD;7 Stephen J. Kim, MD;8 Edward J. Wladis, MD9

    Ophthalmology, Vol. 130, Issue 12, P1336-1341, © 2023 by the American Academy of Ophthalmology. Click here for free access to the OTA. 

    Purpose: To review the literature to determine the efficacy and safety of thermal pulsation technologies in improving signs or symptoms of meibomian gland dysfunction (MGD) and dry eye compared with no therapy or with conventional warm compress therapy or eyelid hygiene.

    Methods: A literature search was conducted in the PubMed database in June 2022 and again in March 2023 to identify all studies in the English language on the use of thermal pulsation to treat MGD or dry eye. The search yielded 59 citations, and 11 articles met all of the inclusion criteria. The panel methodologist then assigned a level of evidence rating for each study; 8 studies were rated level I evidence and 3 studies were rated level II evidence.

    Results: All included studies evaluated a single 12-minute session using the LipiFlow automated thermal pulsation system (TearScience, Inc, or Johnson & Johnson). Improvements were detected in subjective and objective metrics of MGD or dry eye in patients within 1 to 12 months of thermal pulsation treatment compared with nontreatment. Most of the studies (9/11) reported greater efficacy with thermal pulsation than with standard warm compress therapy and eyelid hygiene. Four of these studies showed relevant industry conflicts of interest. Two of the 4 level I studies without direct industry participation concluded that thermal pulsation treatment was not significantly different from conventional hygiene or warm compress therapy control treatments (in symptoms in one of the studies and in objective findings in the second study). No serious adverse events were reported in any of the 11 studies.

    Conclusions: According to the current literature, a single thermal pulsation session may improve subjective or objective parameters of MGD and dry eye safely. However, industry support and participation were present in 4 of the 8 level I studies. The durability beyond several months and cost efficacy remain uncertain. Because the inclusion parameters of this assessment captured only the LipiFlow system, the conclusions are limited to that product. High-quality independent studies are needed to assess the long-term benefits of this intervention.

    1Gavin Herbert Eye Institute, University of California, Irvine School of Medicine, Irvine, California 
    2Mayo Clinic Arizona, Scottsdale, Arizona 
    3Department of Ophthalmology and Visual Sciences; University of Michigan; Ann Arbor, MI
    4Ophthalmic Surgeons and Consultants of Ohio, Columbus, Ohio  
    5Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts
    6Department of Ophthalmology, John P. McGovern Medical School, University of Texas Health Science Center, Houston, Texas 
    7Tufts University School of Medicine, Boston, Massachusetts
    8Department of Ophthalmology, Vanderbilt University School of Medicine, Nashville, Tennessee 
    9Ophthalmic Plastic Surgery, Lions Eye Institute, Department of Ophthalmology, Albany Medical Center, Albany (Slingerlands), New York