LACRYSTIM: Intense Pulsed Light in Meibomian Gland Dysfunctions

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT04147962
Collaborator
Quantel Medical (Industry)
45
1
7.2
6.2

Study Details

Study Description

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 Phase
  • Device: intense pulsed light (usual practice)

Study Design

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 :
Oct 25, 2019
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Lacrydiag in current clinical practice [6 months]

    The LacryDiag ocular surface analyzer is used for the diagnosis of dry eyes.

Secondary Outcome Measures

  1. collection of adverse events [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 [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 [6 months]

    in current clinical practice

  4. Oxford Score [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 [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 [6 months]

    measured in current clinical practice. Determination of the quantity of tears produced.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 CHU de Saint Etienne Saint Etienne France 42055

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne
  • Quantel Medical

Investigators

  • Principal Investigator: Marie Caroline TRONE, MD, CHU de Saint Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT04147962
Other Study ID Numbers:
  • IRBN672019/CHUSTE
First Posted:
Nov 1, 2019
Last Update Posted:
May 13, 2022
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2022