Intense Regulated Pulse Light Therapy in Dry Eye Disease

Study Overview
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Brief Summary
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The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.

Detailed Description
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Dry eye disease is a common ocular condition that needs prompt diagnosis and careful treatment interventions. If left untreated, it can lead to numerous sight threatening complications, including ulceration of the cornea, blepharitis, alterations of the tear film, conjunctivitis, and in severe cases, significant drying of the eye may lead to scarring, thinning, and even perforation of the cornea. Intense pulsed light (IPL) therapy is a new treatment strategy for treatment of MGD by inducing the restoration of the normal activity of the meibomian glands. In fact, IPL has been used for treating the patients with facial telangiectasias and erythema of rosacea and also resulted in improvement in ocular surface health. Evaporative form is the commonest form of DED and it is mainly caused by meibomian glands dysfunction (MGD). The usual traditional treatment options for MGD include warm compresses, expression of meibomian glands (MG), anti-inflammatory drugs, and lubricant eye drops. The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye. The study included 34 patients with moderate to severe evaporative dry eye. The symptoms will be assessed with the Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire. The tear film will be assessed through MediWorks D130+S390L (WDR) which is a device attached to the slit lamp for non-invasive examination of tear film. Patients will be divided into 2 groups: The 1st group include (17) patients who will be treated with Intense Regulated Pulse Light (IRPL) & the 2nd group include (17) patients will treated by traditional methods of MGD as Eyelid hygiene, topical lubricant, topical & systemic antibiotics & anti-inflammatory agents IRPL will be done using E-Eye (E-Swin, France) & each patient will undergo 3 sessions on Day (1), Day (15), and Day (45). The patients will be reassessed after the 3rd session.

Official Title
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Therapeutic Effect of Intense Regulated Pulse Light in Patients With Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Procedure: IPRL device
* Procedure: pharmacological therapy & Eyelid hygiene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with moderate to severe dry eye disease & clinicaily significant signs of meibomian gland dysfunction Exclusion Criteria: Use systemic medications known to affect the eye two weeks prior to baseline assessment. Pregnancy. Ocular surgery or dermatologic treatments in the previous Two months or during the treatment period. Implants, tattoos, or pigmented lesions in the treatment area. Contraindications to IPL therapy, including the use of photosensitive medications.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IRPL Therapy<br>17 patients with moderate to severe evaporative dry eye disease will treated with 3 sessions of IRPL therapy. | Procedure: IPRL device<br>* Intense pulsed light therapy (IPL) is a non-coherent large wavelength high-intensity light in the range of 500-1200nm. It has been used by many investigators for the treatment of evaporative dry eye safely and effectively.<br>|
| Active Comparator: Non IRPL Therapy<br>17 patients with moderate to severe evaporative dry eye disease will treated with traditional methods of MGD | Procedure: pharmacological therapy & Eyelid hygiene<br>* traditional methods of MGD treatment as Eyelid hygiene, topical preservative free lubricant, topical & systemic antibiotics & anti-inflammatory agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive tear film break up time | assessment of tear film through MediWorks device attached to the slitlamp | before treatment | 
| Change in Non-invasive tear film break up time | assessment of tear film through MediWorks device attached to the slitlamp | Within 1 month after completion of treatment | 
| Tear Meniscus Height | assessment of tear film through MediWorks device attached to the slitlamp | before treatment | 
| Change in Tear Meniscus Height | assessment of tear film through MediWorks device attached to the slitlamp | Within 1 month after completion of treatment | 
| Lipid layer thickness | assessment of tear film through MediWorks device attached to the slitlamp | before treatment | 
| Change in Lipid layer thickness | assessment of tear film through MediWorks device attached to the slitlamp | Within 1 month after completion of treatment | 
| Meibomian glands % loss grading | assessment of tear film through MediWorks device attached to the slitlamp | before treatment | 
| Change in Meibomian glands % loss grading | assessment of tear film through MediWorks device attached to the slitlamp | Within 1 month after completion of treatment | 
| patient's quality of life affection | The effect of dry eye on the patient's Quality Of Life was evaluated with the aid of Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire. | before treatment | 
| Change in patient's quality of life affection | The effect of dry eye on the patient's Quality Of Life was evaluated with the aid of Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire. | Within 1 month after completion of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MGD, IPL therapy, IRPL therapy, Dry eye