Intense Pulsed Light in Meibomian Gland Dysfunctions

Dry Eye Syndromes Clinical Trial

— LACRYSTIM  

Official title:

Intense Pulsed Light in Meibomian Gland Dysfunctions: Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147962
• Other study ID #: IRBN672019/CHUSTE
• Status: Completed
• Start date: October 25, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Meibomian Gland Dysfunction

Intervention

Device:
• intense pulsed light (usual practice)
collection data : parameters used for each treatment session: duration of treatment session and intensity of intense pulsed light

Locations

Country	Name	City	State
France	CHU de Saint Etienne	Saint Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Quantel Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lacrydiag in current clinical practice	The LacryDiag ocular surface analyzer is used for the diagnosis of dry eyes.	6 months
Secondary	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
Secondary	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
Secondary	Slit lamp Photography x16 and x25	in current clinical practice	6 months
Secondary	Oxford Score	measured in current clinical practice. The Oxford score is used to assess epithelial damage to the cornea and conjunctiva.	6 months
Secondary	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
Secondary	Schirmer Test	measured in current clinical practice. Determination of the quantity of tears produced.	6 months