The Efficacy and Safety of New-Generation Intense Pulsed Light in the Treatment of Meibomian Gland Dysfunction-Related Dry Eye: A Multicenter, Randomized, Patients-Blind, Parallel-Control, Non-Inferiority Clinical Trial

Abstract

Introduction: This study aimed to evaluate the efficacy and safety of a new-generation intense pulsed light (IPL) device in improving the symptoms and signs of meibomian gland dysfunction (MGD)-related dry eye, and compare it with a traditional IPL device.

Methods: This multicenter randomized controlled trial enrolled 132 patients with MGD-related dry eye from two centers. Patients were randomly assigned into the new-generation IPL (Eyesis) group or traditional IPL (E-Eye) group, and then blinded to receive treatment on days 0 and 7. Ocular Surface Disease Index (OSDI), tear meniscus height (TMH), tear breakup time (TBUT), corneal fluorescein staining (CFS), Schirmer test, and meibomian gland signs were evaluated on days 0, 7, and 14. The primary outcome was defined as the effective rate of treating MGD at day 14. Any adverse events were recorded for safety assessment. Intergroup comparisons and non-inferiority analysis were performed. p values less than 0.05 were considered statistically significant.

Results: Basic information showed no significant difference between treatment groups. The intergroup difference of the effective rate was - 1.7% in the left eye and 1.6% in right eye, verifying the non-inferiority of the Eyesis device (p = 0.927). Significant improvements in OSDI, TBUT, Schirmer test, TMH, CFS, and meibomian gland signs were observed in Eyesis group on days 7 and 14 (all p < 0.05). Compared to the E-Eye group, the Eyesis group achieved more significant improvements in OSDI, TBUT, Schirmer test, TMH, and meibum quality (all p < 0.05). There was no significant difference in the incidences of adverse events between groups (p = 1.000).

Conclusions: The new-generation IPL was effective and safe in relieving the symptoms and signs of MGD-related dry eye, exhibiting a non-inferior effective rate compared to the traditional IPL. Additionally, Eyesis showed more clinical benefits over E-Eye in alleviating symptoms, increasing tear film stability and improving meibomian gland function.

Keywords: Dry eye; Intense pulsed light; Meibomian gland dysfunction; Tear film.

Fig. 1

CONSORT flow diagram

Fig. 2

Intragroup comparisons of OSDI, TBUT, Schirmer test between day 7, day 14, and baseline (day 0) in group A. OSDI ocular surface disease index, TBUT tear-film break up time, L left eye, R right eye. *Statistically significant difference between day 0 and day 7 (p < 0.05); **statistically significant difference between day 0 and day 14 (p < 0.05)

Fig. 3

Intragroup comparisons of TMH, CFS, MGE, gland dropout, and meibum quality between day 7, day 14, and baseline (day 0) in group A. a Comparisons in left eyes in group A. b Comparisons in right eyes in group A. L left eye, R right eye, TMH lower tear meniscus height, CFS corneal fluorescein staining, MGE meibomian gland expressibility; ^aevaluated on day 0; ^bevaluated on day 7; ^cevaluated on day 14; *statistically significant difference between day 0 and day 7 (p < 0.05); **statistically significant difference between day 0 and day 14 (p < 0.05)