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Ocul Surf. 2014 Apr;12(2):146-54. doi: 10.1016/j.jtos.2013.12.001. Epub 2014 Jan 22.

Evaluation of an automated thermodynamic treatment (LipiFlow®) system for meibomian gland dysfunction: a prospective, randomized, observer-masked trial.

Author information

1
Department of Ophthalmology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany. Electronic address: David.Finis@med.uni-duesseldorf.de.
2
Department of Ophthalmology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.

Abstract

PURPOSE:

To compare the effectiveness of a single LipiFlow(®) treatment with combined lid warming and massage in patients with meibomian gland dysfunction (MGD).

METHODS:

In this prospective, randomized, crossover, observer-masked clinical trial, subjects were randomized to receive either a single 12-min LipiFlow-LipiFlow Thermal Pulsation (LTP) system treatment or to perform combined twice-daily lid warming and massage for 3 months. All subjects were examined before, and 1 and 3 months after initiation of treatments. Investigated parameters included subjective symptoms, lipid layer thickness, meibomian gland assessment, tear break-up time, tear osmolarity, corneal and conjunctival staining, Schirmer test values, and tear meniscus height.

RESULTS:

A total of 31 subjects completed the 3-month follow-up. At 1 and 3 months, patients in the LipiFlow treatment group had a significant reduction in Ocular Surface Disease Index (OSDI) scores compared with those in the lid-margin hygiene group. Both treatments produced a significant improvement in expressible meibomian glands compared to the baseline parameters, but no significant difference was noted between the two groups. The other investigated objective parameters did not show a significant difference.

CONCLUSION:

Results of our study show that a single LipiFlow treatment is as least as effective as a 3-month, twice-daily lid margin hygiene regimen for MGD. However, the present study was observer-masked only, and therefore a placebo effect may have confounded any improvements in subjective symptoms and other parameters in both groups.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01769105.

KEYWORDS:

LipiFlow(®); dry eye; meibomian gland dysfunction (MGD)

PMID:
24725326
DOI:
10.1016/j.jtos.2013.12.001
[Indexed for MEDLINE]

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