A retrospective study of the efficacy of intense pulsed light delivered by the Lacrystim® for meibomian gland dysfunction therapy

Marie-Caroline Trone, Thibaud Garcin, Edouard Ollier, Gilles Thuret, Philippe Gain, Marie-Caroline Trone, Thibaud Garcin, Edouard Ollier, Gilles Thuret, Philippe Gain

Abstract

Background: Meibomian gland dysfunction is the most common etiology of dry eye disease worldwide and intense pulsed light appears to be a promising treatment with encouraging results. Lacrystim® is a new IPL device (CE marking in 2019) and no studies have yet been published on it. We propose the first study on this device with an objective assessment of its efficacy and an extended follow-up over 6 months.

Methods: Patients presenting with a dry eye disease (DED) with stable mild to moderate MGD and having received Lacrystim® treatment between june 2019 and june 2020 were included. 3 IPL sessions were performed at D0, D15 and D45 with 4 shots per side at a fluence of 8 mJ/cm2. DED clinical evaluation was performed at D0, D15, D45, 3rd month and 6th month: Oxford scale and break up time, Schirmer test and Ocular Surface Disease Index (OSDI) questionnaire. Lacrydiag® imaging device carried out an objective examination of tear film: interferometry, meibography, tear meniscus height and non-invasive break up time (NIBUT). The primary endpoint was the evolution in NIBUT between the first visit D0 and 3rd month. Data collection was done retrospectively. Statistical analysis was done using a linear mixed-effects model and a non-parametric linear mixed-effects model (R software).

Results: Forthy five consecutive patients were included. NIBUT significantly increased between D0 and 3rd month: mean difference of 1.63 seconds, IC95% [0.51; 2.62], (p = 0.002) with a prolonged effect at 6th month. OSDI and OXFORD scores and interferometry were also significantly improved at 3rd month and 6th month. There was no significant change in BUT, Schirmer test and tear meniscus height. No adverse event was noted.

Conclusions: IPL delivered by Lacrystim® appears effective and safe to treat MGD although a randomized controlled trial is needed to validate its results.

Trial registration: This work was approved by a local ethics committee "Terre d'éthique" (institutional review board number: IRBN672019/CHUSTE) and registered on the clinicaltrial.gov website ( NCT04147962 , 01/11/2019).

Keywords: Dry eye disease; Intense pulsed light; Meibomian gland dysfunction; NIBUT.

Conflict of interest statement

Marie-Caroline TRONE, Gilles THURET and Philippe GAIN received fees from Quantel Medical to design the retrospective analysis chart. Quantel Medical played no role in data analysis, interpretation or writing of this work. Other authors have no competing interest.

All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Installation during a session of IPL treatment. The patient closed his/her eyes under the protective glasses during shooting. A is applied to the cheekbones. Four shots are made per side. (publication permission obtained from the patient)
Fig. 2
Fig. 2
Boxplot of non-invasive break-up-time (NIBUT) (A), ocular surface disease index (OSDI) (B) Oxford score (C) and interferometry (D) changes over time. Thick horizontal lines show the distribution median; boxes, the interquartile range (IQR); and individual points, the outliers between 1.5 and 3 times the IQR. Whiskers mark the highest and lowest non-outlying values. A Median NIBUT increased with time: 8.6 at day (D) 0, 8.7 at D45, 9.3 at 3rd month and 9.6 at 6th month. B OSDI score significantly improved over time with medians at 42.7 at D0, 34.2 at D45, 34.3 at 3rd month and 35.4 at 6th month. C Oxford score improved over time with medians at 2.0 at D0, 1.0 at D45, 1.0 at 3rd month and 1.0 at 6th month. D Interferometry significantly improved with a constant median over time at 30 at D0, D45, 3rd month and 6th month
Fig. 3
Fig. 3
Example of tests performed with LACRYDIAG® on a patient whose OSDI score improves from 45.8 at D0 to 27.08 at 3rd month. A NIBUT at D0 measured at 3.8 seconds. B NIBUT to 3rd month measured at 9.5 seconds. C Height of tear meniscus (unchanged by IPL treatment). D Interferometry (unchanged by IPL treatment). E Meibography of the right upper eyelid showing atrophy of the meibomius glands (unchanged by IPL treatment)

References

    1. Asbell PA, Stapleton FJ, Wickström K, Akpek EK, Aragona P, Dana R, et al. The international workshop on meibomian gland dysfunction: report of the clinical trials subcommittee. Invest Ophthalmol Vis Sci. mars. 2011;52(4):2065–2085. doi: 10.1167/iovs.10-6997h.
    1. Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017;15(3):438–510. doi: 10.1016/j.jtos.2017.05.011.
    1. Arita R, Mizoguchi T, Kawashima M, Fukuoka S, Koh S, Shirakawa R, et al. Meibomian gland dysfunction and dry eye are similar but different based on a population-based study: the Hirado-Takushima study in Japan. Am J Ophthalmol. 2019;207:410–418. doi: 10.1016/j.ajo.2019.02.024.
    1. Sabeti S, Kheirkhah A, Yin J, Dana R. Management of meibomian gland dysfunction: a review. Surv Ophthalmol avr. 2020;65(2):205–217. doi: 10.1016/j.survophthal.2019.08.007.
    1. Husain Z, Alster TS. The role of lasers and intense pulsed light technology in dermatology. Clin Cosmet Investig Dermatol. 2016;9:29–40.
    1. Paasch U, Schwandt A, Seeber N, Kautz G, Grunewald S, Haedersdal M. New lasers and light sources - old and new risks? J Dtsch Dermatol Ges J Ger Soc Dermatol JDDG mai 2017;15(5):487–496.
    1. Jones L, Downie LE, Korb D, Benitez-Del-Castillo JM, Dana R, Deng SX, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15(3):575–628. doi: 10.1016/j.jtos.2017.05.006.
    1. Liu R, Rong B, Tu P, Tang Y, Song W, Toyos R, et al. Analysis of cytokine levels in tears and clinical correlations after intense pulsed light treating Meibomian gland dysfunction. Am J Ophthalmol nov 2017;183:81–90.
    1. Suwal A, Hao JL, Zhou DD, Liu XF, Suwal R, Lu CW. Use of intense pulsed light to mitigate Meibomian gland dysfunction for dry eye disease. Int J Med Sci. 2020;17(10):1385–1392. doi: 10.7150/ijms.44288.
    1. Tashbayev B, Yazdani M, Arita R, Fineide F, Utheim TP. Intense pulsed light treatment in meibomian gland dysfunction: A concise review. Ocul Surf. 3 juill 2020;
    1. Dell SJ. Intense pulsed light for evaporative dry eye disease. Clin Ophthalmol Auckl NZ. 2017;11:1167–1173. doi: 10.2147/OPTH.S139894.
    1. Lam PY, Shih KC, Fong PY, Chan TCY, Ng ALK, Jhanji V, et al. A review on evidence-based treatments for Meibomian gland dysfunction. Eye Contact Lens janv. 2020;46(1):3–16. doi: 10.1097/ICL.0000000000000680.
    1. Fishman HA, Periman LM, Shah AA. Real-Time Video Microscopy of In Vitro Demodex Death by Intense Pulsed Light. Photobiomodulation Photomed Laser Surg. 27 janv 2020;
    1. Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, et al. TFOS DEWS II diagnostic methodology report. Ocul Surf. 2017;15(3):539–574. doi: 10.1016/j.jtos.2017.05.001.
    1. Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, et al. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci mars. 2011;52(4):2006–2049. doi: 10.1167/iovs.10-6997f.
    1. Remeseiro B, Bolon-Canedo V, Peteiro-Barral D, Alonso-Betanzos A, Guijarro-Berdiñas B, Mosquera A, et al. A methodology for improving tear film lipid layer classification. IEEE J Biomed Health Inform juill. 2014;18(4):1485–1493. doi: 10.1109/JBHI.2013.2294732.
    1. Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the ocular surface disease index. Arch Ophthalmol Chic Ill 1960. mai 2000;118(5):615–621.
    1. Guillemin I, Begley C, Chalmers R, Baudouin C, Arnould B. Appraisal of patient-reported outcome instruments available for randomized clinical trials in dry eye: revisiting the standards. Ocul Surf avr. 2012;10(2):84–99. doi: 10.1016/j.jtos.2012.01.007.
    1. Noguchi K, GEL YR, Brunner E, et al. An R software package for the nonparametric analysis of longitudinal data in factorial experiments. J Stat Softw. 2012;50(12).
    1. Dessau RB, Pipper CB. [“R"--project for statistical computing]. Ugeskr Laeger. 28 janv 2008;170(5):328–30.
    1. Wickham H. ggplot2. WIREs Comput Stat 4 févr 2011;3(2):180–185.
    1. Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol juin. 1988;124(6):869–871. doi: 10.1001/archderm.1988.01670060015008.
    1. Jiang X, Lv H, Song H, Zhang M, Liu Y, Hu X, et al. Evaluation of the safety and effectiveness of intense pulsed light in the treatment of Meibomian gland dysfunction. J Ophthalmol. 2016;2016:1910694.
    1. Karaca EE, Evren Kemer Ö, Özek D. Intense regulated pulse light for the meibomian gland dysfunction. Eur J Ophthalmol mars. 2020;30(2):289–292. doi: 10.1177/1120672118817687.
    1. Arita R, Mizoguchi T, Fukuoka S, Morishige N. Multicenter study of intense pulsed light therapy for patients with refractory Meibomian gland dysfunction. Cornea déc. 2018;37(12):1566–1571. doi: 10.1097/ICO.0000000000001687.
    1. Guilloto Caballero S, García Madrona JL, Colmenero RE. Effect of pulsed laser light in patients with dry eye syndrome. Arch Soc Espanola Oftalmol. 92(11):509–15.
    1. Toyos R, McGill W, Briscoe D. Intense pulsed light treatment for dry eye disease due to meibomian gland dysfunction; a 3-year retrospective study. Photomed Laser Surg janv. 2015;33(1):41–46. doi: 10.1089/pho.2014.3819.
    1. Craig JP, Chen YH, Turnbull PRK. Prospective trial of intense pulsed light for the treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 12 févr 2015;56(3):1965–1970.
    1. Wei S, Ren X, Wang Y, Chou Y, Li X. Therapeutic effect of intense pulsed light (IPL) combined with Meibomian gland expression (MGX) on Meibomian gland dysfunction (MGD) J Ophthalmol. 2020;2020:3684963.
    1. Vegunta S, Patel D, Shen JF. Combination therapy of intense pulsed light therapy and Meibomian gland expression (IPL/MGX) can improve dry eye symptoms and Meibomian gland function in patients with refractory dry eye: a retrospective analysis. Cornea mars. 2016;35(3):318–322. doi: 10.1097/ICO.0000000000000735.
    1. Arita R, Fukuoka S, Morishige N. Therapeutic efficacy of intense pulsed light in patients with refractory meibomian gland dysfunction. Ocul Surf. 2019;17(1):104–110. doi: 10.1016/j.jtos.2018.11.004.
    1. Piyacomn Y, Kasetsuwan N, Reinprayoon U, Satitpitakul V, Tesapirat L. Efficacy and safety of intense pulsed light in patients with Meibomian gland dysfunction-a randomized, double-masked. Sham-Controlled Clinical Trial Cornea. 2020;39(3):325–332.
    1. Jewsbury H, Morgan F. Uveitis and iris photoablation secondary to intense pulsed light therapy. Can J Ophthalmol J Can Ophtalmol août. 2012;47(4):e13–e14. doi: 10.1016/j.jcjo.2012.01.019.
    1. Chang CY, Sheu SJ. Choroidal neovascularization secondary to intense pulsed light injury. Ophthal Plast Reconstr Surg. août. 2018;34(4):e129–e131. doi: 10.1097/IOP.0000000000001142.
    1. Lee WW, Murdock J, Albini TA, O’brien TP, Levine ML. Ocular damage secondary to intense pulse light therapy to the face. Ophthal Plast Reconstr Surg août. 2011;27(4):263–265. doi: 10.1097/IOP.0b013e31820c6e23.
    1. Yan X, Hong J, Jin X, Chen W, Rong B, Feng Y, et al. 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. Eye Contact Lens. 19 mai 2020;
    1. Li D, Lin SB, Cheng B. Intense pulsed light treatment for Meibomian gland dysfunction in skin types III/IV. Photobiomodulation Photomed Laser Surg févr. 2019;37(2):70–76. doi: 10.1089/photob.2018.4509.
    1. Rennick S, Adcock L. Intense Pulsed Light Therapy for Meibomian Gland Dysfunction: A Review of Clinical Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 [cité 12 déc 2019]. (CADTH rapid response reports). Disponible sur:

Source: PubMed

3
Sottoscrivi