Intense Pulsed Light Therapy in Meibomian Gland Dysfunction

Study Overview
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Brief Summary
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to evaluate the effect of intense pulsed light on resistant patients with Meibomian gland dysfunction

Official Title
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Intense Pulsed Light Therapy in the Treatment of Refractory Meibomian Gland Dysfunction

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: intense pulsed light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age of at least 20 years. The diagnosis of obstructive MGD based on ocular symptoms, plugged gland oriﬁces, vascularity and irregularity of lid margins, and reduced meibum expression (meibum grade of .1, where grade 0 = clear meibum easily expressed, grade 1 = cloudy meibum expressed with mild pressure, grade 2 = cloudy meibum expressed with more than moderate pressure, and grade 3 = meibum could not be expressed even with strong pressure). failure of at least 3 types of conventional MGD therapy to improve symptoms or objective ﬁndings for at least 1 year before study treatment Exclusion Criteria: the presence of active skin lesions, skin cancer, or other speciﬁc skin pathology. active ocular infection or ocular inﬂammatory disease.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: flourescein staining, miboscore<br> | Device: intense pulsed light<br>* treatment with 3 sessions of intense pulsed light, the second one after 2 weeks, the third one after 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film break up time (TBUT) | After instillation of fluorescein in the conjunctival sac with fluorescein sodium strips (Jingming New TechnologicalDevelopment Co Ltd, Tianjin, China), the subject was asked to blink several times. Then, the tear film was observed under the slitlamp, using a cobalt blue filter to increase the visual contrast. For each eye, TBUT was evaluated three consecutive times, and the average of these three measurements was calculated and taken for the analysis.TBUT, a cut-off value of 5 sec was used to distinguish between moderate/severe TBUT (#5 sec) and mild/normal TBUT (.5 sec) | 6 months | 
| schirmmer staining | doctor places a piece of filter paper inside the lower eyelid of both eyes and the person closes their eyes. After 5 minutes, the doctor removes the filter paper. The doctor then assesses how far the tears have travelled on the paper. Result under 10 mm is considered to be an abnormally low level of tear production | 6 months | 
| Standard Patient Evaluation of Eye Dryness (SPEED)questionnaire | the self evaluated Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (Tear Science, Morrisville, VC). This validated questionnaire asked the subject to grade the frequency and severity of four symptoms categories: (1) dryness, grittiness or scratchiness; (2) soreness or irritation; (3) burning or watering; and (4) eye fatigue. For each of these symptom categories, the subject subscored the frequency using a 4-point scale (0 never, 1 sometimes, 2 often, 3 constant), and subscored the severity using a 5-point scale (0 none, 1 tolerable, 2 uncomfortable, 3 bothersome, 4 intolerable). The SPEED score was calculated as the sum of these eight subscores. A SPEED score of 10 is widely accepted as indicating severe DED symptoms, and a cut-off value around six is often used to distinguish between asymptomatic/mild and moderate/severe symptoms. | 6 months |