Intense Regulated Pulse Light Therapy in Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553561
• Other study ID #: 7/2022OPHT23
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Menoufia University
• Contact: Rofaida Mostafa Mansour, Master degree in ophthalmology
• Phone: 01000502442
• Email: drrofaidamostafa1989[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Procedure:
• IPRL device
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.
• pharmacological therapy & Eyelid hygiene
traditional methods of MGD treatment as Eyelid hygiene, topical preservative free lubricant, topical & systemic antibiotics & anti-inflammatory agent

Locations

Country	Name	City	State
Egypt	Monoufia university	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-invasive tear film break up time	assessment of tear film through MediWorks device attached to the slitlamp	before treatment
Primary	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
Primary	Tear Meniscus Height	assessment of tear film through MediWorks device attached to the slitlamp	before treatment
Primary	Change in Tear Meniscus Height	assessment of tear film through MediWorks device attached to the slitlamp	Within 1 month after completion of treatment
Primary	Lipid layer thickness	assessment of tear film through MediWorks device attached to the slitlamp	before treatment
Primary	Change in Lipid layer thickness	assessment of tear film through MediWorks device attached to the slitlamp	Within 1 month after completion of treatment
Primary	Meibomian glands % loss grading	assessment of tear film through MediWorks device attached to the slitlamp	before treatment
Primary	Change in Meibomian glands % loss grading	assessment of tear film through MediWorks device attached to the slitlamp	Within 1 month after completion of treatment
Primary	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
Primary	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