NCT04147962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 13, 2022

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 25, 2019

Last Update Submit

May 12, 2022

Conditions

Keywords

intense pulsed light

Outcome Measures

Primary Outcomes (1)

  • Lacrydiag in current clinical practice

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

    6 months

Secondary Outcomes (6)

  • collection of adverse events

    6 months

  • Ocular Surface Disease Index questionnaire

    6 months

  • Slit lamp Photography x16 and x25

    6 months

  • Oxford Score

    6 months

  • Break-up time Test

    6 months

  • +1 more secondary outcomes

Study Arms (1)

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)

Interventions

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

Patients with dry eye disease with meibomian gland dysfunction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • patient with incomplete follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Study Officials

  • Marie Caroline TRONE, MD

    CHU de Saint Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2019

First Posted

November 1, 2019

Study Start

October 25, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

May 13, 2022

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations