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Effectiveness and Safety of Intense Pulsed Light in Patients With Meibomian Gland Dysfunction

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ClinicalTrials.gov Identifier: NCT03518398
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Yonrawee Piyacomn, M.D., FICO, Chulalongkorn University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction (Disorder) Dry Eye Syndromes Device: Intense Pulsed Light Combination Product: Standard treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Intense Pulsed Light in Patients With Meibomian Gland Dysfunction
Actual Study Start Date : July 3, 2018
Actual Primary Completion Date : April 2, 2019
Actual Study Completion Date : April 2, 2019

Arm Intervention/treatment
Experimental: IPL group
IPL 9-13 J/cm2 according to Fitzpatrick's skin type on day 0, 15, 45
Device: Intense Pulsed Light
E> Eye (E-SWIN, Paris, France) IPL machine

Combination Product: Standard treatment
warm compression, lid scrub and non-preservative ocular lubricants

Sham Comparator: sham-IPL group
IPL 0 J/cm2 according to Fitzpatrick's skin type on day 0, 15, 45
Combination Product: Standard treatment
warm compression, lid scrub and non-preservative ocular lubricants




Primary Outcome Measures :
  1. Change in fluorescein tear break-up time at month 6 using fluorescein technique [ Time Frame: day 0, 15, 45, month 3, month 6 ]
    time elapsed from the last complete eyelid blink until appearance of the first dry spot on the cornea


Secondary Outcome Measures :
  1. Change in dry eye symptoms using Ocular Surface Disease Index (OSDI), a questionnaire, at month 6 [ Time Frame: day 0, 15, 45, month 3, 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.

  2. Change in lipid layer thickness at month 6 using LipiView interferometer (TearScience inc., Morrisville,NC) [ Time Frame: day 0, 15, 45, month 3, month 6 ]
    quantitative values of the tear-film lipid layer depth or thickness by imaging the surface contour of the tear film, lipid layer thickness measurement

  3. Change in Meibomian gland's anatomy by Meiboscore using Meibography at month 6 using Keratograph 5M (OCULUS, Wetzlar, Germany) [ Time Frame: day 0, 15, 45, month 3, month 6 ]
    directly visualising the morphology of meibomian glands in vivo

  4. Change in ocular surface staining at month 6 using fluorescein staining technique [ Time Frame: day 0, 15, 45, month 3, month 6 ]
    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

  5. Change in Meibomian gland expressibility at month 6 after applying the force onto the eyelids using meibomian gland evaluator [ Time Frame: day 0, 15, 45, month 3, month 6 ]
    number of glands expressible after applying force onto the eyelids

  6. Change in Meibum quality at month 6 after applying the force onto the eyelids using meibomian gland evaluator [ Time Frame: day 0, 15, 45, month 3, month 6 ]
    quality of the meibum content after applying the force onto the eyelids

  7. Change in tear osmolarity at month 6 using TearLab Osmolarity System (San Diego, CA) [ Time Frame: day 0, 45, month 3, month 6 ]
    concentration of the tear : The investigators use TearLab Osmolarity System (San Diego, CA)

  8. Change in tear production test (Schirmer's test) at month 3 using calibrated strips of a non-toxic filter paper [ Time Frame: day 0, month 3 ]
    is used determine whether the lacrimal glands produce enough tears to keep the eyes adequately moist

  9. Change in tear cytokines Interleukins-1 receptor antagonist (IL-1Ra) at month 3 using Bio-Plex® 200 system (Bio-Rad, Hercules, CA) [ Time Frame: day 0, month 3 ]
    one of the tear inflammatory cytokines

  10. Change in tear cytokines Interleukins-6 at month 3 using Bio-Plex® 200 system (Bio-Rad, Hercules, CA) [ Time Frame: day 0, month 3 ]
    one of the tear inflammatory cytokines



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to read, understand and sign an informed consent form
  2. 18-80 years of age
  3. Fitzpatrick skin type 1-5
  4. Able and willing to comply with the treatment /follow-up schedule and requirements
  5. Presence of meibomian gland on each lower eyelid's meibography
  6. Current diagnosis of stage1-4 of MGD in both eyes, according to the International Workshop on Meibomian Gland Dysfunction: Report of the Subcommittee on Management and Treatment of Meibomian Gland Dysfunction

Exclusion Criteria:

  1. Contact lens wearer within the past 1 month and throughout the study
  2. Recent ocular surgery or eyelid surgery within the past 6 months
  3. Neuro-paralysis in the planned treatment area within the past 6 months
  4. Current use of punctual plugs
  5. Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
  6. Uncontrolled infections or uncontrolled immunosuppressive diseases
  7. Subjects who have undergone refractive surgery within the past 6 months
  8. Diseases in the planned treatment area that could be stimulated by light at 560 nm to 1200 nm (e.g.,Herpes simplex 1 and 2, Systemic Lupus Erythematosus, porphyria)
  9. Use of photosensitive medications and/or herbs that may cause sensitivity to 560-1200 nm light exposure, such as isotretinoin, tetracycline, or St. John's Wort
  10. Pregnancy and lactation
  11. Radiation therapy to the head or neck within the past year, or planned radiation therapy throughout study period
  12. Treatment with chemotherapeutic agent within the past 8 weeks, or planned chemotherapy throughout study period
  13. Any condition revealed during the eligibility screening process whereby the physician deems the subject inappropriate for this study
  14. Declared legally blind in one eye
  15. IPL treatment within the past 12 months
  16. Lipiflow treatment, or any equivalent treatments, within the past 12 months
  17. Any anti-glaucomatous eye drop uses within the past 3 months and throughout the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518398


Locations
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Thailand
Yonrawee Piyacomn
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
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Principal Investigator: Yonrawee Piyacomn, MD Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

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Responsible Party: Yonrawee Piyacomn, M.D., FICO, Yonrawee Piyacomn, MD, FICO, Principal Investigator, Fellow of Cornea and Refractive Surgery Unit, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03518398     History of Changes
Other Study ID Numbers: Yonrawee Piyacomn
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yonrawee Piyacomn, M.D., FICO, Chulalongkorn University:
Intense pulsed light
Meibomian gland dysfunction
Dry eye
cytokines
Additional relevant MeSH terms:
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Dry Eye Syndromes
Eye Diseases
Lacrimal Apparatus Diseases