Intense Regulated Pulse Light Therapy in Dry Eye Disease

Menoufia University

Status: Enrolling

Conditions: Dry Eye Disease

Treatments: Procedure: IPRL device; Procedure: pharmacological therapy & Eyelid hygiene

Study type: Interventional

Funder types: Other

Identifiers

NCT05553561

7/2022OPHT23

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

IRPL Therapy

Active Comparator group

Description:

17 patients with moderate to severe evaporative dry eye disease will treated with 3 sessions of IRPL therapy.

Treatment:

Procedure: IPRL device

Non IRPL Therapy

Active Comparator group

Description:

17 patients with moderate to severe evaporative dry eye disease will treated with traditional methods of MGD

Treatment:

Procedure: pharmacological therapy & Eyelid hygiene