Intense Pulsed Light in Meibomian Gland Dysfunctions (LACRYSTIM)

Intense Pulsed Light in Meibomian Gland Dysfunctions: Retrospective Study

Dry eye disease (DED) is an extremely common disease whose meibomian gland dysfunction is the main etiology.

Polychromatic intense pulsed light (IPL) is a promising new therapeutic alternative but few clinical data have been published.

A new IPL device has recently been marketed: LACRYSTIM (QUANTEL, France). The investigators have been using it in our clinical practice since June 2019.

The investigators present a retrospective study on our first clinical results.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Meibomian Gland Dysfunction
• Intervention / Treatment: Device: intense pulsed light (usual practice)

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • CHU de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Dry eye disease with meibomian gland dysfunction, preferentially mild to moderate, and having benefited from intense pulsed light treatment

Description

Inclusion Criteria:

• Patients with Dry eye disease with meibomian gland dysfunction, preferentially mild to moderate, and having benefited from intense pulsed light treatment.
• patient affiliated with a social security organization

Exclusion Criteria:

• patient with incomplete follow-up

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with dry eye disease with meibomian gland dysfunction; Collected data from patient records for consultations Day 0, Day 15 and Day 45 (3 treatment sessions) and Months 3, Months 6 (follow-up consultations). - parameters used for each treatment session: duration of treatment session and intensity of intense pulsed light	Device: intense pulsed light (usual practice); collection data : parameters used for each treatment session: duration of treatment session and intensity of intense pulsed light

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lacrydiag in current clinical practice	The LacryDiag ocular surface analyzer is used for the diagnosis of dry eyes.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
collection of adverse events	-data concerning the safety: presence or absence of adverse events during treatment or afterwards (burns, tingling, redness of skin ...)	6 months
Ocular Surface Disease Index questionnaire	measured in current clinical practice. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers.	6 months
Slit lamp Photography x16 and x25	in current clinical practice	6 months
Oxford Score	measured in current clinical practice. The Oxford score is used to assess epithelial damage to the cornea and conjunctiva.	6 months
Break-up time Test	measured in current clinical practice. The measurement of the tear film rupture time determines the stability of the tear film, i.e. the degree of humidification of the eyes.	6 months
Schirmer Test	measured in current clinical practice. Determination of the quantity of tears produced.	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Quantel Medical
• Investigators: Principal Investigator: Marie Caroline TRONE, MD, CHU de Saint Etienne

Publications and helpful links

General Publications

• Trone MC, Garcin T, Ollier E, Thuret G, Gain P. A retrospective study of the efficacy of intense pulsed light delivered by the Lacrystim(R) for meibomian gland dysfunction therapy. BMC Ophthalmol. 2022 Aug 6;22(1):335. doi: 10.1186/s12886-022-02531-7.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: intense pulsed light
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Dry Eye Syndromes; Meibomian Gland Dysfunction
• Other Study ID Numbers: IRBN672019/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No