PURPOSE

To evaluate the effectiveness and the safety of LipiFlow for treating signs and symptoms of dry eye disease (DED) in adults.

METHODS

The following databases were searched for randomized trials: CENTRAL, MEDLINE Ovid, Embase.com, PubMed, LILACS, ClinicalTrials.gov, and WHO ICTRP on 24 October 2022. The included studies were conducted in adults (≥18 years) with DED or meibomian gland dysfunction (MGD) as defined by the investigators. Standard Cochrane methodology was applied.

RESULTS

This study included 13 trials that randomized a total of 1,155 participants (66 % female; age range = 19 to 86 years). Five trials compared LipiFlow with basic warm compresses. Analyzing symptom scores in these trials yielded conflicting evidence of a difference in symptoms between LipiFlow and basic warm compresses after 4 weeks. There was no evidence of a difference in meibomian gland expression, meibum quality, or tear breakup time when comparing LipiFlow with basic warm compresses. Another 5 trials compared LipiFlow with thermostatic devices. Analysis of symptom scores in these trials at 4 weeks showed that thermostatic devices had reduced Ocular Surface Disease Index (OSDI) scores by a mean difference of 4.59 as compared with LipiFlow. The remaining 3 included trials could not be grouped for comparisons. The overall evidence was of low or very low certainty, with most trials being assessed as having a high risk of bias. No trial reported any intervention-related, vision-threating adverse events.

CONCLUSIONS

LipiFlow performs similarly to other DED treatments. Further research with adequate masking and a standardized testing methodology is still needed.