Research conducted by the American Academy of Ophthalmology (AAO) and published in Ophthalmology explored the efficacy and safety of thermal pulsation for improving meibomian gland dysfunction (MGD) and dry eye.
Talk about this research.
Investigators conducted a literature search of the PubMed database (twice; in June 2022 and May 2023) with the intent to identify all English-speaking studies that used thermal pulsation as treatment for either MGD or dry eye.
Their goal: to compare thermal pulsation to other conventional therapies (such as warm compresses and eyelid hygiene) as well as no therapy.
How many studies were selected?
Out of 59 citations, 11 studies met 100% of the inclusion criteria. From there, each study was assigned an evidence rating level:
- Level 1: 8 studies
- Level 2: 3 studies
To note, Level 1 indicates a high strength/quality prospective cohort study; Level 2 indicates a lesser quality prospective cohort study.
Details, please.
Participants in each of the studies underwent single, 12-minute sessions using the LipiFlow automated thermal pulsation (TearScience, Inc.; Johnson & Johnson).
The placebo patients in each study were treated with either lid hygiene or warm compress therapy.
And the results?
For all studies, the first 12 months noted improvements in all thermal pulsation-treated participants for both subjective and objective metrics of MGD and dry eye (versus patients treated with alternative or no therapies).
Give me specifics.
Nearly 82% (9/11) of the studies reported a greater efficacy in dry eye or MGD with thermal pulsation compared to the alternative therapies; however, four of these studies reported “relevant industry conflicts of interest.”
Did any report no greater efficacy?
Actually, yes.
Two studies (of the Level 1 evidence rating) concluded there was no significant difference between thermal pulsation treatment and the alternative therapies.
To note, these studies did not have any direct industry conflicts.
What about adverse events?
According to the study authors, no serious adverse events (SAEs) were reported among all studies.
So what did they conclude?
Based on the findings, the authors concluded that “a single thermal pulsation session may improve subjective or objective parameters of MGD and dry eye safely.”
I’m sensing a ‘but’ here …
You sensed right.
The authors cautioned that, with 50% of the Level 1 studies including industry support or participation, these findings may be limited to an assessment of only cases that used the LipiFlow system.
As a result, their conclusion can only be directed toward thermal pulsation treatment used with that product.
Anything else?
As each of the 11 studies only included data through 1 year, the authors stated that the durability of the LipiFlow system beyond that time point (as well as cost efficacy) are uncertain.
What do they recommend?
They advised that high-quality studies using other thermal pulsation system products are needed in order to assess the long-term benefits and outcomes for dry eye and MGD patient care.