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


Journal

BMC ophthalmology
ISSN: 1471-2415
Titre abrégé: BMC Ophthalmol
Pays: England
ID NLM: 100967802

Informations de publication

Date de publication:
06 Aug 2022
Historique:
received: 28 04 2022
accepted: 11 07 2022
entrez: 6 8 2022
pubmed: 7 8 2022
medline: 10 8 2022
Statut: epublish

Résumé

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

Sections du résumé

BACKGROUND 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 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 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 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 BACKGROUND
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).

Identifiants

pubmed: 35933379
doi: 10.1186/s12886-022-02531-7
pii: 10.1186/s12886-022-02531-7
pmc: PMC9356507
doi:

Banques de données

ClinicalTrials.gov
['NCT04147962']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

335

Informations de copyright

© 2022. The Author(s).

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Auteurs

Marie-Caroline Trone (MC)

Ophthalmology department, University Hospital, 42055 Saint-Etienne Cedex1, Saint-Etienne, France. mariecarolinetrone@gmail.com.
Corneal Graft Biology, Engineering and Imaging Laboratory BiiGC, EA2521, Health innovation campus, faculty of Medicine, Jean Monnet University, Saint-Etienne, France. mariecarolinetrone@gmail.com.

Thibaud Garcin (T)

Ophthalmology department, University Hospital, 42055 Saint-Etienne Cedex1, Saint-Etienne, France.
Corneal Graft Biology, Engineering and Imaging Laboratory BiiGC, EA2521, Health innovation campus, faculty of Medicine, Jean Monnet University, Saint-Etienne, France.

Edouard Ollier (E)

Clinical Research, Innovation and Pharmacology Unit, University Hospital, Saint-Etienne, France.
Health engineering biology (SAINBIOSE) Inserm U1059, vascular hemostasis dysfunction (DVH) team, Health innovation campus, faculty of Medicine, Jean Monnet University, Saint-Etienne, France.

Gilles Thuret (G)

Ophthalmology department, University Hospital, 42055 Saint-Etienne Cedex1, Saint-Etienne, France.
Corneal Graft Biology, Engineering and Imaging Laboratory BiiGC, EA2521, Health innovation campus, faculty of Medicine, Jean Monnet University, Saint-Etienne, France.

Philippe Gain (P)

Ophthalmology department, University Hospital, 42055 Saint-Etienne Cedex1, Saint-Etienne, France.
Corneal Graft Biology, Engineering and Imaging Laboratory BiiGC, EA2521, Health innovation campus, faculty of Medicine, Jean Monnet University, Saint-Etienne, France.

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Classifications MeSH