Clinical trial NCT05553561: Intense Regulated Pulse Light Therapy in Dry Eye Disease
Official title: Therapeutic Effect of Intense Regulated Pulse Light in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Disease
Keywords: IPL therapy
IRPL therapy
Dry eye
MGD
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Non-invasive tear film break up time
timeFrame: before treatment
measure: Change in Non-invasive tear film break up time
timeFrame: Within 1 month after completion of treatment
measure: Tear Meniscus Height
timeFrame: before treatment
measure: Change in Tear Meniscus Height
timeFrame: Within 1 month after completion of treatment
measure: Lipid layer thickness
timeFrame: before treatment
measure: Change in Lipid layer thickness
timeFrame: Within 1 month after completion of treatment
measure: Meibomian glands % loss grading
timeFrame: before treatment
measure: Change in Meibomian glands % loss grading
timeFrame: Within 1 month after completion of treatment
measure: patient's quality of life affection
timeFrame: before treatment
measure: Change in patient's quality of life affection
timeFrame: Within 1 month after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Menoufia
country: Egypt
facility: Monoufia university
Study officials:
References: