MGD-Meibomian Gland DysfunctionNCT06468930
Efficacy of Adjunctive Low-Level Light Therapy to Intense Pulsed Light for Meibomian Gland Dysfunction
A study testing Low-level light therapy (LLLT) and Intense pulsed light (IPL) in people with MGD-Meibomian Gland Dysfunction, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to compare the effectiveness of adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) versus intense pulsed light (IPL) alone for the treatment of meibomian gland dysfunction (MGD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MGD-Meibomian Gland Dysfunction
- What is being tested?
- Low-level light therapy (LLLT) and Intense pulsed light (IPL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteThailand
- Study dates
- 2 Oct 2024to May 2025
- Phase
- Interventional
- 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
Who may be able to join
- MGD severity level 2 and above according to the international workshop on MGD
- Fitzpatrick skin type of 1-4 according to sun sensitivity characteristics and appearance of the skin color
Who cannot join
- History of previous ocular trauma or surgery within the past six months
- Contact lens-wearing patients
- Patients with skin-pigmented lesions in the treatment area
- Pregnancy or breastfeeding patients
- Patients with any uncontrolled ocular or systemic diseases
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn memorial hospital
Bangkok, 10330
Chatchada Kharuhayothin, +66922496151, chatchada.kharuhayothin@gmail.com
Lita Uthaithammarat, lita.c@chula.ac.th
About this study
The goal of this clinical trial is to compare the effectiveness of adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) versus intense pulsed light (IPL) alone for the treatment of meibomian gland dysfunction (MGD).
The main question it aims to answer is does the adjunctive of low-level light therapy (LLLT) to intense pulsed light (IPL) provide more beneficial treatment effects than intense pulsed light (IPL) alone in treating meibomian gland dysfunction (MGD) patients?
Participants will be randomized into 2 groups: adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) group (ALLLT +IPL) and IPL alone group.
Read the detailed description
In both the IPL group and the ALLLT+IPL group, the doctor will administer IPL therapy to each participant and apply the Light Modulation® special facial mask to their faces. The assistant nurse will activate the light power, ensuring that the doctor remains blind to treatment allocation. Participants in both groups will receive a conventional treatment for MGD including warm compression and lid hygiene. Moreover, all participants will be advised to use preservative-free artificial tears 4 times daily throughout the study.
- Conditions
- MGD-Meibomian Gland Dysfunction
- Being tested
- Low-level light therapy (LLLT), Intense pulsed light (IPL)
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level light therapy (LLLT)Device
LLLT therapy will be delivered using the Light Modulation® special facial mask (Espansione Marketing S.p.A., Bologna, Italy) which will be placed on the participant's face for 15 minutes. The mask has the shape of a half-face and will emit a red light in an LED system. The device has an emission power of 100 The mask has the shape of a half-face and will emit a red light in a light-emitting diode (LED) system. The device has an emission power of 100 milliwatts per square centimeter.
Intense pulsed light (IPL)Device
The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim
| Study group | Role | What they receive |
|---|---|---|
| ALLLT + IPL group | Experimental | Participants will receive a session of IPL therapy followed by LLLT therapy, once weekly for 4 weeks (total 4 treatment sessions). The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim. The LLLT therapy will be delivered using the Light Modulation® special facial mask (Espansione Marketing S.p.A., Bologna, Italy) which will be placed on the participant's face for 15 minutes. The mask has the shape of a half-face and will emit a red light in a light-emitting diode (LED) system. Receives: Device: Low-level light therapy (LLLT); Device: Intense pulsed light (IPL) |
| IPL alone group | Active comparator | The IPL alone group will receive only a session of IPL therapy, once weekly for 4 weeks (total 4 treatment sessions). The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim, similar to the combined group. Additionally, the special facial mask will also be placed on the participant's face for 15 minutes with no light power applied. Receives: Device: Intense pulsed light (IPL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid layer thickness (LLT)
Lipid layer thickness will be evaluated using Lipiview® II interferometer (TearScience®, Johnson \& Johnson Vision, California, USA). The thickness of the lipid layer is then calculated from the interference pattern and expressed in interferometric color units (ICU), where 1 ICU reflects approximately 1 nm of lipid layer thickness.
Measured: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Secondary outcomes (7)
Meibum quality score
Meibum quality grade will be evaluated on central 8 glands at the lower lid with grade 0 indicating clear meibum, 1 indicating cloudy meibum, 2 indicating cloudy particulate meibum, and 3 indicating inspissated, like toothpaste meibum.
Measured: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Meibum expressibility score
Meibum expressibility score will be evaluated on central 8 glands at the lower lid with 0 indicating all glands expressible, 1 indicating 3-4 glands expressible, 2 indicating 1-2 glands expressible, and 3 indicating no gland expressible.
Measured: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Meiboscore
Meibography will be evaluated using Lipiview® II interferometer (TearScience®, Johnson \& Johnson Vision, California, USA) Meiboscore will be graded according to meibomian gland dropout; grade 0 indicates no loss of meibomian gland, grade 1 indicates less than 25% gland loss, grade 2 indicates 25-50% gland loss, grade 3 indicates 50-75% gland loss, and grade 4 indicates more than 75% gland loss.
Measured: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Tear film break-up time (TBUT)
TBUT will be measured using the standard fluorescein staining method.
Measured: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Conjunctival and corneal staining:
Conjunctival and corneal staining will be evaluated using National Eye Institute (NEI) industry scale ranging from 0-33.
Measured: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Ocular surface disease index (OSDI) scores
OSDI scores will be evaluated using a validated questionnaire, with a total score ranging from 0-100. Higher values indicating greater symptom severity; normal (<12), mild (13-22) moderate (23-32) or severe (33-100).
Measured: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Tear cytokines levels
Tear samples were collected using a Schirmer strip placed at the inferior fornix without anesthesia waiting for 5 minutes, then the strip will be kept in a 2 ml centrifuge tube. The samples were stored at -20°C for further assays.
Measured: baseline and 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start2 Oct 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MGD-Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chatchada Kharuhayothin, Principal investigator, Ophthalmology department, Faculty of medicine, Chulalongkorn university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468930
- Sponsor's protocol ID
- 0666/66
- Status last verified
- Feb 2024
- First submitted
- 28 Mar 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adjunctive Low-Level Light Therapy to Intense Pulsed Light for Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT06468930
- Acronym / sponsor ID
- 0666/66
- Conditions
- MGD-Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 21 Jun 2024 (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.
The goal of this clinical trial is to compare the effectiveness of adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) versus intense pulsed light (IPL) alone for the treatment of meibomian gland dysfunction (MGD).
The main question it aims to answer is does the adjunctive of low-level light therapy (LLLT) to intense pulsed light (IPL) provide more beneficial treatment effects than intense pulsed light (IPL) alone in treating meibomian gland dysfunction (MGD) patients?
Participants will be randomized into 2 groups: adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) group (ALLLT +IPL) and IPL alone group.
Detailed description
In both the IPL group and the ALLLT+IPL group, the doctor will administer IPL therapy to each participant and apply the Light Modulation® special facial mask to their faces. The assistant nurse will activate the light power, ensuring that the doctor remains blind to treatment allocation. Participants in both groups will receive a conventional treatment for MGD including warm compression and lid hygiene. Moreover, all participants will be advised to use preservative-free artificial tears 4 times daily throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLLT + IPL group | Experimental | Device: Low-level light therapy (LLLT), Device: Intense pulsed light (IPL)Participants will receive a session of IPL therapy followed by LLLT therapy, once weekly for 4 weeks (total 4 treatment sessions). The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim. The LLLT therapy will be delivered using the Light Modulation® special facial mask (Espansione Marketing S.p.A., Bologna, Italy) which will be placed on the participant's face for 15 minutes. The mask has the shape of a half-face and will emit a red light in a light-emitting diode (LED) system. |
| IPL alone group | Active comparator | Device: Intense pulsed light (IPL)The IPL alone group will receive only a session of IPL therapy, once weekly for 4 weeks (total 4 treatment sessions). The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim, similar to the combined group. Additionally, the special facial mask will also be placed on the participant's face for 15 minutes with no light power applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- MGD severity level 2 and above according to the international workshop on MGD
- Fitzpatrick skin type of 1-4 according to sun sensitivity characteristics and appearance of the skin color
Key exclusion criteria (5 listed)
- History of previous ocular trauma or surgery within the past six months
- Contact lens-wearing patients
- Patients with skin-pigmented lesions in the treatment area
- Pregnancy or breastfeeding patients
- Patients with any uncontrolled ocular or systemic diseases
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 |
|---|---|---|
| Low-level light therapy (LLLT)LLLT therapy will be delivered using the Light Modulation® special facial mask (Espansione Marketing S.p.A., Bologna, Italy) which will be placed on the participant's face for 15 minutes. The mask has the shape of a half-face and will emit a red light in an LED system. The device has an emission power of 100 The mask has the shape of a half-face and will emit a red light in a light-emitting diode (LED) system. The device has an emission power of 100 milliwatts per square centimeter. | Device | ALLLT + IPL group |
| Intense pulsed light (IPL)The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim | Device | ALLLT + IPL group, IPL alone group |
Primary outcome
Lipid layer thickness (LLT)
Time frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Lipid layer thickness will be evaluated using Lipiview® II interferometer (TearScience®, Johnson \& Johnson Vision, California, USA). The thickness of the lipid layer is then calculated from the interference pattern and expressed in interferometric color units (ICU), where 1 ICU reflects approximately 1 nm of lipid layer thickness.
7 secondary outcomes
Meibum quality score
Time frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Meibum expressibility score
Time frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Meiboscore
Time frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Tear film break-up time (TBUT)
Time frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Conjunctival and corneal staining:
Time frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Ocular surface disease index (OSDI) scores
Time frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Tear cytokines levels
Time frame: baseline and 12 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- 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.
Chatchada Kharuhayothin principal investigator
Ophthalmology department, Faculty of medicine, Chulalongkorn university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level light therapy (LLLT) and Intense pulsed light (IPL) in people with MGD-Meibomian Gland Dysfunction, run by Chulalongkorn University at 1 site in Thailand.
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 5 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: status not confirmed, as of the sponsor's last update on 5 Nov 2024. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chatchada Kharuhayothin (+66922496151, chatchada.kharuhayothin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid layer thickness (LLT) (time frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2024.