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Meibomian gland dysfunction (MGD) is one of the most common causes of dry eye diseases. Over the past decade, several treatment options in MGD have been extensively studied including warm compression, lid hygiene, ocular lubricants, forceful expression, LipiFlow thermal pulsation system, intraductal probing, debridement scaling and intense pulsed light (IPL). IPL is a broad spectrum, non-coherent and polychromatic light source with a wavelength spectrum of 500-1200 nm. It can be filtered to allow only a range of wavelengths to be emitted. Different wavelength makes different depth of tissue to absorb a specific light energy. Intense pulsed light (IPL) has been widely used in dermatology as a therapeutic tool for removal of hypertrichosis, benign cavernous hemangioma, benign venous malformations, telangiectasia, port-wine stain and pigmented lesions. Concurrent ocular surface improvements have been observed in patients undergone IPL treatment. Very few prospective clinical trials showed that subjective dry eye symptoms decreased and some of the dry eye signs also improved. Nonetheless, there is still inconsistency in the efficacy of IPL among these studies. Biomarkers, specifically cytokines, in dry eye diseases have been studied to some extent. Moreover, the change in ocular surface inflammatory cytokines in patients with MGD after IPL treatment is unclear.
The investigators proposed a prospective randomized double-masked sham-controlled clinical trial to investigate the efficacy and safety of intense pulse light in MGD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPL group | Experimental | IPL 9-13 J/cm2 according to Fitzpatrick's skin type on day 0, 15, 45 |
|
| sham-IPL group | Sham Comparator | IPL 0 J/cm2 according to Fitzpatrick's skin type on day 0, 15, 45 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intense Pulsed Light | Device | E> Eye (E-SWIN, Paris, France) IPL machine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fluorescein tear break-up time at month 6 using fluorescein technique | time elapsed from the last complete eyelid blink until appearance of the first dry spot on the cornea | day 0, 15, 45, month 3, month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dry eye symptoms using Ocular Surface Disease Index (OSDI), a questionnaire, at month 6 | a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. | day 0, 15, 45, month 3, month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yonrawee Piyacomn, MD | Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonrawee Piyacomn | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| ID | Term |
|---|---|
| D062325 | Intense Pulsed Light Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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| Standard treatment |
| Combination Product |
warm compression, lid scrub and non-preservative ocular lubricants |
|
| Change in lipid layer thickness at month 6 using LipiView interferometer (TearScience inc., Morrisville,NC) |
quantitative values of the tear-film lipid layer depth or thickness by imaging the surface contour of the tear film, lipid layer thickness measurement |
| day 0, 15, 45, month 3, month 6 |
| Change in Meibomian gland's anatomy by Meiboscore using Meibography at month 6 using Keratograph 5M (OCULUS, Wetzlar, Germany) | directly visualising the morphology of meibomian glands in vivo | day 0, 15, 45, month 3, month 6 |
| Change in ocular surface staining at month 6 using fluorescein staining technique | fluorescein dye which is a mildly invasive stain that marks the tear film and defects in the corneal and conjunctival epithelium. The investigators use National Eye Institute (NEI) grading for ocular surface staining score in this study | day 0, 15, 45, month 3, month 6 |
| Change in Meibomian gland expressibility at month 6 after applying the force onto the eyelids using meibomian gland evaluator | number of glands expressible after applying force onto the eyelids | day 0, 15, 45, month 3, month 6 |
| Change in Meibum quality at month 6 after applying the force onto the eyelids using meibomian gland evaluator | quality of the meibum content after applying the force onto the eyelids | day 0, 15, 45, month 3, month 6 |
| Change in tear osmolarity at month 6 using TearLab Osmolarity System (San Diego, CA) | concentration of the tear : The investigators use TearLab Osmolarity System (San Diego, CA) | day 0, 45, month 3, month 6 |
| Change in tear production test (Schirmer's test) at month 3 using calibrated strips of a non-toxic filter paper | is used determine whether the lacrimal glands produce enough tears to keep the eyes adequately moist | day 0, month 3 |
| Change in tear cytokines Interleukins-1 receptor antagonist (IL-1Ra) at month 3 using Bio-Plex® 200 system (Bio-Rad, Hercules, CA) | one of the tear inflammatory cytokines | day 0, month 3 |
| Change in tear cytokines Interleukins-6 at month 3 using Bio-Plex® 200 system (Bio-Rad, Hercules, CA) | one of the tear inflammatory cytokines | day 0, month 3 |