Intense Regulated Pulse Light Therapy in Dry Eye Disease
- Conditions
- Dry Eye Disease
- Interventions
- Procedure: IPRL deviceProcedure: pharmacological therapy & Eyelid hygiene
- Registration Number
- NCT05553561
- Lead Sponsor
- Menoufia University
- Brief Summary
The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 34
- Patients with moderate to severe dry eye disease & clinicaily significant signs of meibomian gland dysfunction
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IRPL Therapy IPRL device 17 patients with moderate to severe evaporative dry eye disease will treated with 3 sessions of IRPL therapy. Non IRPL Therapy pharmacological therapy & Eyelid hygiene 17 patients with moderate to severe evaporative dry eye disease will treated with traditional methods of MGD
- Primary Outcome Measures
Name Time Method Tear Meniscus Height before treatment assessment of tear film through MediWorks device attached to the slitlamp
Change in Tear Meniscus Height Within 1 month after completion of treatment assessment of tear film through MediWorks device attached to the slitlamp
Lipid layer thickness before treatment assessment of tear film through MediWorks device attached to the slitlamp
Change in Non-invasive tear film break up time Within 1 month after completion of treatment assessment of tear film through MediWorks device attached to the slitlamp
Change in Lipid layer thickness Within 1 month after completion of treatment assessment of tear film through MediWorks device attached to the slitlamp
Change in Meibomian glands % loss grading Within 1 month after completion of treatment assessment of tear film through MediWorks device attached to the slitlamp
Change in patient's quality of life affection Within 1 month after completion of treatment 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.
Non-invasive tear film break up time before treatment assessment of tear film through MediWorks device attached to the slitlamp
Meibomian glands % loss grading before treatment assessment of tear film through MediWorks device attached to the slitlamp
patient's quality of life affection before treatment 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Monoufia university
🇪🇬Menoufia, Egypt