The Efficacy of Intense Pulsed Light Combined With Meibomian Gland Expression for the Treatment of Dry Eye Disease Due to Meibomian Gland Dysfunction: A Multicenter, Randomized Controlled Trial

Xiaoming Yan, Jing Hong, Xiuming Jin, Wei Chen, Bei Rong, Yun Feng, Xiaodan Huang, Jinyang Li, Wenjing Song, Lin Lin, Yu Cheng, Xiaoming Yan, Jing Hong, Xiuming Jin, Wei Chen, Bei Rong, Yun Feng, Xiaodan Huang, Jinyang Li, Wenjing Song, Lin Lin, Yu Cheng

Abstract

Objectives: To compare the efficacy of intense pulsed light (IPL) combined with Meibomian gland expression (MGX), and instant warm compresses combined with MGX, for treatment of dry eye disease (DED) due to meibomian gland dysfunction (MGD).

Methods: In a prospective, multicenter, interventional study, 120 subjects with DED due to MGD were randomized 1:1 to an IPL arm or a control arm. Each subject was treated 3 times at 3-week intervals. The primary outcome measure was the tear break up time (TBUT). Tear break up time and a few additional outcome measures were evaluated at the baseline and at 3 weeks after the last treatment.

Results: All outcome measures improved in both arms, but in general, the improvement was significantly larger in the IPL arm. Tear break up time increased by 2.3±1.9 and 0.5±1.4 sec, in the IPL and control arms respectively (P<0.001). SPEED was reduced by 38% and 22% in the IPL and control arms, respectively (P<0.01). Meibomian Gland Yielding Secretion Score was improved by 197% in the IPL arm and 96% in the control arm. Corneal fluorescein staining also decreased by 51% and 24% in the IPL and control arms respectively, but the differences between the two arms were not statistically significant (P=0.61). A composite score of lid margin abnormalities improved in both arms, but more in the IPL arm (P<0.05).

Conclusions: Intense pulsed light combined with MGX therapy was significantly more effective than instant warm compresses followed with MGX. This suggests that the IPL component has a genuine contribution to the improvement of signs and symptoms of DED.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Contact Lens Association of Opthalmologists.

Figures

FIG. 1.
FIG. 1.
Intereye correlation of tear breakup time (TBUT). Symbols: TBUT values of OD (right eye) and OS (left eye) in individual subjects; Shaded ellipsoids: 95% confidence intervals; r values: Pearson correlation coefficients; P values: probability of obtaining by chance a correlation with greater absolute value than the computed value (i.e., if no linear relationship exists between TBUT of OD and OS). A1,A2: Baseline and follow-up TBUT values in control subjects; B1,B2: Baseline and follow-sup TBUT values in IPL subjects. IPL, intense pulsed light.
FIG. 2.
FIG. 2.
Change in tear break up time (TBUT). For each subject, TBUT was defined as the arithmetic mean TBUTs in the two eyes. (A) Longitudinal analysis of TBUT, for control subjects (blue squares) and IPL subjects (red circles) at BL, Tx2, Tx3, and FU; Dashed areas: respective 95% confidence intervals; ****P<0.0001, *P<0.05. (B) TBUT at BL (pale colors) and FU (vivid colors), for control subjects (blue bars) and IPL subjects (red bars); error bars: SD; ****P <0.0001, **P<0.01; dashed horizontal line: cutoff value which distinguishes between moderate/severe TBUT and mild/normal TBUT (used in D). (C) Change of TBUT from BL to FU, for control subjects (blue bar) and IPL subjects (red bar); error bars: SEM; ****P<0.0001. (D) Percentage of pts with subclinical or normal TBUT (>5 sec) at BL (pale colors) and FU (vivid colors), for control subjects (blue bars) and IPL subjects (red bars); ****P<0.0001; N/S, nonsignificant; IPL, intense pulsed light.
FIG. 3.
FIG. 3.
Change in symptoms. (A) SPEED scores at BL (pale colors) and FU (vivid colors), in the control subjects (blue bars) and IPL subjects (red bars). Horizontal dashed line: cutoff value which distinguishes between severe symptoms and nonsevere symptoms; Error bars: SD; ****P<0.0001. (B) Change of SPEED score from BL to FU, for control subjects (blue bar) and IPL subjects (red bar); ****P<0.0001. (C) Percentage of pts with severe symptoms at BL (pale colors) and FU (vivid colors), for control subjects (blue bars) and IPL subjects (red bars); ****P<0.0001, **P<0.005. IPL, intense pulsed light.
FIG. 4.
FIG. 4.
Percentage of subjects who significantly improved in secondary outcome measures. Significant improvement of an outcome measure was arbitrarily defined as a change (from BL to FU) which exceeded the median change in the entire sample. (A) Percentage of subjects for whom MGYSS significantly improved (i.e., increased above +3.5, the median change of MGYSS in the entire sample); **P<0.01. (B) Percentage of subjects for whom CFS significantly improved (i.e., decreased below −0.5, the median change of CFS in the entire sample); N/S: nonsignificant. (C) Percentage of subjects for whom the change in the Compound Eyelid Score (CCES) was significantly high (i.e., above the median value of CCES in the entire sample); **P<0.01. CFS, corneal fluorescein staining.

References

    1. Li M, Gong L, Chapin WJ, et al. Assessment of vision-related quality of life in dry eye patients. Invest Ophthalmol Vis Sci 2012;53:5722–5727.
    1. Nelson J, Craig J, Akpek E, et al. TFOS DEWS II introduction. Ocul Surf 2017;15:269–275.
    1. Lemp M, Crews L, Bron A, et al. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort. Cornea 2012;27:472–478.
    1. Mathers W. Ocular evaporation in meibomian gland dysfunction and dry eye. Ophthalmology 1993;100:347–351.
    1. Nelson J, Shimazaki J, Benitez-del-Castillo J, et al. The international workshop on meibomian gland dysfunction: Report of the definition and classification subcommittee. Invest Ophthalm Vis Sci 2011;52:1930–1937.
    1. Jones L, Downie L, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf 2017;15:575–628.
    1. Toyos R, Buffa C, Youngerman S. Case report- Dry–eye symptoms improve with intense pulsed light treatment. EyeWorld 2005;33:41–46.
    1. Viso E, Rodríguez-Ares MD, Oubiña B, et al. Prevalence of asymptomatic and symptomatic meibomian gland dysfunction in the general population of Spain. IOVS 2012;53:2601–2606.
    1. Yin Y, Liu N, Gong L, et al. Changes in the meibomian gland after exposure to intense pulsed light in meibomian gland dysfunction (MGD) patients. Curr Eye Res 2018;43:308–313.
    1. Arita R, Fukuoka S, Morishige N. Therapeutic efficacy of intense pulsed light in patients with refractory meibomian gland dysfunction. Ocul Surf 2019;17:104–110.
    1. Ngo W, Situ P, Keir N, et al. Psychometric properties and validation of the standard patient evaluation of eye dryness questionnaire. Cornea 2013;32:1204–1210.
    1. Blackie C, Solomon J, Scaffidi R, et al. The relationship between dry eye symptoms and lipid layer thickness. Cornea 2009;28:789–794.
    1. Asiedu K, Kyei S, Mensah S, et al. Ocular surface disease index (OSDI) versus the standard patient evaluation of eye dryness (SPEED): A study of a nonclinical sample. Cornea 2016;35:175–180.
    1. Korb D, Blackie C. Meibomian gland diagnostic expressibility: Correlation with dry eye symptoms and gland location. Cornea 2008;27:1142–1147.
    1. Experts' consensus about clinical diagnosis and treatment. Chin J Ophthalmol 2013;49:73–75.
    1. Tomlinson A, Korb D, Amano S, et al. The international workshop on meibomian gland dysfunction: Report of the diagnosis subcommittee. IOVS 2011;52:2006–2049.
    1. Lane S, DuBiner H, Epstein R, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction. Cornea 2012;31:396–404.
    1. Tong A, Passi S, Gupta P. Clinical outcomes of Lifitegrast 5% ophthalmic solution in the treatment of dry eye disease. Eye Contact Lens 2020;46(Suppl 1):S20–S24.
    1. Wolffsohn J, Arita R, Chalmers R, et al. TFOS DEWS II diagnostic methodology report. Ocul Surf 2017;15:539–574.
    1. Dell S. Intense pulsed light for evaporative dry eye disease. Clin Ophthalmol 2017;11:1167–1173.
    1. Prieto V, Sadick N, Lloreta J, et al. Effects of intense pulsed light on sun-damaged human skin, routine, and ultrastructural analysis. Lasers Surg Med 2002;30:82–85.
    1. Zhang X, Song N, Gong L. Therapeutic effect on intense pulsed light on ocular demodicosis. Curr Eye Res 2019;44:250–256.
    1. Schroeter C, Haaf-von BS, Neumann H. Effective treatment of rosacea using intense pulsed light systems. Dermatol Surg 2005;31:1285–1289.

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