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Trial record 1 of 1 for:    intense pulsed light | France
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Intense Pulsed Light in Meibomian Gland Dysfunctions (LACRYSTIM)

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ClinicalTrials.gov Identifier: NCT04147962
Recruitment Status : Completed
First Posted : November 1, 2019
Last Update Posted : May 13, 2022
Sponsor:
Collaborator:
Quantel Medical
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Dry Eye Syndromes Meibomian Gland Dysfunction Device: intense pulsed light (usual practice)

Study Design
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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intense Pulsed Light in Meibomian Gland Dysfunctions: Retrospective Study
Actual Study Start Date : October 25, 2019
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Lacrydiag in current clinical practice [ Time Frame: 6 months ]
    The LacryDiag ocular surface analyzer is used for the diagnosis of dry eyes.


Secondary Outcome Measures :
  1. collection of adverse events [ Time Frame: 6 months ]
    -data concerning the safety: presence or absence of adverse events during treatment or afterwards (burns, tingling, redness of skin ...)

  2. Ocular Surface Disease Index questionnaire [ Time Frame: 6 months ]
    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.

  3. Slit lamp Photography x16 and x25 [ Time Frame: 6 months ]
    in current clinical practice

  4. Oxford Score [ Time Frame: 6 months ]
    measured in current clinical practice. The Oxford score is used to assess epithelial damage to the cornea and conjunctiva.

  5. Break-up time Test [ Time Frame: 6 months ]
    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. Schirmer Test [ Time Frame: 6 months ]
    measured in current clinical practice. Determination of the quantity of tears produced.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147962


Locations
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France
CHU de Saint Etienne
Saint Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Quantel Medical
Investigators
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Principal Investigator: Marie Caroline TRONE, MD CHU de Saint Etienne
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04147962    
Other Study ID Numbers: IRBN672019/CHUSTE
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
intense pulsed light
Additional relevant MeSH terms:
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Dry Eye Syndromes
Meibomian Gland Dysfunction
Lacrimal Apparatus Diseases
Eye Diseases
Eyelid Diseases