Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction

Study Overview
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Brief Summary
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This study aimed to determine the therapeutic effectiveness of different machines in intense pulsed light (IPL) treatment of meibomian gland dysfunction (MGD). Subjects diagnosed with MGD underwent three sessions of IPL treatment in a control (M22) treatment group or experimental (OPL-I) treatment group and were followed up three to four weeks after each session. Tear breakup time (TBUT), meibomian gland secretion scores (MGSS), meibomian gland meibum scores (MGMS), corneal fluorescein staining (CFS) scores, and the Standard Patient Evaluation of Eye Dryness (SPEED) was used to assess eye dryness signs and symptoms at baseline and follow-up visits.

Official Title
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Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction

Conditions
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MGD-Meibomian Gland Dysfunction

Intervention / Treatment
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* Procedure: Intense pulsed light
* Drug: 0.3% hyaluronic acid eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fitzpatrick skin type I-IV according to sun sensitivity and skin appearance A Standard Patient Evaluation of Eye Dryness (SPEED) score of ≥6 Tear breakup time (TBUT) of ≤10 s in the studied eye Corneal fluorescein staining (CFS) score of ≥1 (it is not necessary to consider this criterion if the TBUT is ≤5 s) Meibomian gland secretion score (MGSS) of ≥6 in the studied eye. Exclusion Criteria: Use of prescription eye drops (excluding artificial tears) within 48 hours of recruitment Facial IPL treatment within the prior 12 months Any surgery of the eye or eyelids within the prior six months Ocular surface and eyelid abnormalities Any systemic condition that might cause eye dryness Use of photosensitive drugs within the prior three months Precancerous lesions Skin cancer or pigmented lesions in the treatment area Overexposure to the sun within the previous month Ocular infections within the previous six months Uncontrolled infections or immunosuppressive diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The trial aimed to assess therapeutic effectiveness of the study treatment arm (OPL-I with the dual filter system; Miracle Laser systems, Wuhan, China) to the control treatment arm (M22 with a single filter; Lumenis, Yokneam, Israel). Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPL-I<br>Patients treated with OPL-I with the dual filter system | Procedure: Intense pulsed light<br>* Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.<br>Drug: 0.3% hyaluronic acid eye drops<br>* 0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.<br>|
| Active Comparator: M22<br>Patients treated with OPL-I with the single filter system | Procedure: Intense pulsed light<br>* Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.<br>Drug: 0.3% hyaluronic acid eye drops<br>* 0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPEED Scores | Standard Patient Evaluation of Eye Dryness questionnaire | Baseline, 1 month, 2 months, 3 months, 4 months | 
| CFS scores | corneal fluorescein staining scores | Baseline, 1 month, 2 months, 3 months, 4 months | 
| TBUT | Tear breakup time | Baseline, 1 month, 2 months, 3 months, 4 months | 
| MGSS | Meibomian gland secretion scores. The MGSS evaluates the obstruction of meibum along the lower eyelid. Three positions along the lower eyelid were detected (five nasal, five central, and five temporal meibomian glands). A score of 0 indicated secretion by all five glands, a score of 1 indicated secretion by three to four glands, a score of 2 indicated secretion by one or two glands, and a score of 3 indicated no secretion by any glands. | Baseline, 1 month, 2 months, 3 months, 4 months | 
| MGMS | meibomian gland meibum scores. The MGMS evaluates the quality of meibum along the lower eyelid, with a score of 0 indicating clear liquid meibum, a score of 1 indicating cloudy liquid meibum, a score of 2 indicating cloudy granular meibum, and a score of 3 indicating toothpaste-like solid meibum). | Baseline, 1 month, 2 months, 3 months, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA | best-corrected visual acuity | Baseline, 4 months | 
| IOP | intraocular pressure measurements | Baseline, 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MGD, IPL, Non-inferiority analysis