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OpenTrials
Completed

NCT Number: NCT04147962

Intense Pulsed Light in Meibomian Gland Dysfunctions

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intense pulsed light (usual practice)

Device

collection data : parameters used for each treatment session: duration of treatment session and intensity of intense pulsed light

Primary outcomes

  1. Lacrydiag in current clinical practice

    Time frame: 6 months

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Quantel Medical

Registry information

Official study title

Intense Pulsed Light in Meibomian Gland Dysfunctions: Retrospective Study

Acronym: LACRYSTIM

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2019
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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