The ILux compared to the mechanical meibomian gland expression for the treatment of moderate and severe meibomian gland dysfunction.

AIM

To compare the safety and effectiveness of eyelid treatment with the ILux-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD).

METHODS

A prospective, randomized, open-label, and controlled clinical trial that compared one session of the ILux MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients aged ≥18y with Ocular Surface Disease Index (OSDI) scores ≥13, total meibomian gland scores (MGS) of <15 in the lower eyelid of each eye, and non-invasive tear break-up time (NI-TBUT) <10s, who were randomized 1:1 to ILux or MMGE.

RESULTS

The mean age was 58±17.49y. Baseline total MGS scores in both treatment groups were comparable. During follow-up, there were significant differences in total MGS and per sector with <0.001. Multivariate analysis was performed using generalized estimating equations corresponding to the generalized linear model for repeated means to determine the treatment relationship with total MGS, NIBUT, and OSDI. There was a significant difference between ILux and MMGE (<0.001) at follow-up from the first to the twelfth month in MGS, NI-BUT, and OSDI scores. No adverse events were reported.

CONCLUSION

ILux treatment compared to MMGE significantly improves symptoms and signs in patients with moderate to severe MGD for one year without adverse events.