MGD-Meibomian Gland Dysfunction
Conditions
Brief 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). 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.
Interventions
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.
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
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid layer thickness (LLT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meibum expressibility score | baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment | 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. |
| Meiboscore | baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment | 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. |
| Tear film break-up time (TBUT) | baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment | TBUT will be measured using the standard fluorescein staining method. |
| Meibum quality score | baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment | 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. |
| Ocular surface disease index (OSDI) scores | baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment | 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). |
| Tear cytokines levels | baseline and 12 weeks post treatment | 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. |
| Conjunctival and corneal staining: | baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment | Conjunctival and corneal staining will be evaluated using National Eye Institute (NEI) industry scale ranging from 0-33. |
Countries
Thailand
Contacts
Primary ContactChatchada Kharuhayothin
Backup ContactLita Uthaithammarat
Outcome results
None listed