Dry Eye SyndromesLACRYSTIMNCT04147962
Intense Pulsed Light in Meibomian Gland Dysfunctions
An observational study of Dry Eye Syndromes and Meibomian Gland Dysfunction, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- What is being tested?
- intense pulsed light (usual practice)
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2019to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Dry eye disease with meibomian gland dysfunction, preferentially mild to moderate, and having benefited from intense pulsed light treatment
Who may be able to join
- 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
Who cannot join
- patient with incomplete follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intense Pulsed Light in Meibomian Gland Dysfunctions: Retrospective Study
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.
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Being tested
- intense pulsed light (usual practice)
- Keywords
- intense pulsed light
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intense pulsed light (usual practice)Device
collection data : parameters used for each treatment session: duration of treatment session and intensity of intense pulsed light
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: intense pulsed light (usual practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lacrydiag in current clinical practice
The LacryDiag ocular surface analyzer is used for the diagnosis of dry eyes.
Measured: 6 months
Secondary outcomes (6)
collection of adverse events
-data concerning the safety: presence or absence of adverse events during treatment or afterwards (burns, tingling, redness of skin ...)
Measured: 6 months
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.
Measured: 6 months
Slit lamp Photography x16 and x25
in current clinical practice
Measured: 6 months
Oxford Score
measured in current clinical practice. The Oxford score is used to assess epithelial damage to the cornea and conjunctiva.
Measured: 6 months
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.
Measured: 6 months
Schirmer Test
measured in current clinical practice. Determination of the quantity of tears produced.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start25 Oct 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Quantel Medical
- Responsible party
- Sponsor
- Investigators
- Marie Caroline TRONE, MD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147962
- Sponsor's protocol ID
- IRBN672019/CHUSTE
- Acronym
- LACRYSTIM
- Status last verified
- Oct 2019
- First submitted
- 25 Oct 2019
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35933379
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intense Pulsed Light in Meibomian Gland Dysfunctions: Retrospective Study
- ClinicalTrials.gov ID
- NCT04147962
- Acronym / sponsor ID
- LACRYSTIM / IRBN672019/CHUSTE
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Keywords
- intense pulsed light
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Quantel Medical
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with dry eye disease with meibomian gland dysfunction | – | Device: intense pulsed light (usual practice)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Dry eye disease with meibomian gland dysfunction, preferentially mild to moderate, and having benefited from intense pulsed light treatment
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- patient with incomplete follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intense pulsed light (usual practice)collection data : parameters used for each treatment session: duration of treatment session and intensity of intense pulsed light | Device | Patients with dry eye disease with meibomian gland dysfunction |
Primary outcome
Lacrydiag in current clinical practice
Time frame: 6 months
The LacryDiag ocular surface analyzer is used for the diagnosis of dry eyes.
6 secondary outcomes
collection of adverse events
Time frame: 6 months
Ocular Surface Disease Index questionnaire
Time frame: 6 months
Slit lamp Photography x16 and x25
Time frame: 6 months
Oxford Score
Time frame: 6 months
Break-up time Test
Time frame: 6 months
Schirmer Test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Derived from this study: PubMed 35933379Trone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Caroline TRONE, MD principal investigator
CHU de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndromes and Meibomian Gland Dysfunction, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lacrydiag in current clinical practice (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04147962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.