Intense Regulated Pulse Light Therapy in Dry Eye Disease

Sponsor

Menoufia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05553561

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Procedure: IPRL device Procedure: pharmacological therapy & Eyelid hygiene	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IRPL Therapy 17 patients with moderate to severe evaporative dry eye disease will treated with 3 sessions of IRPL therapy.	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.
Active Comparator: Non IRPL Therapy 17 patients with moderate to severe evaporative dry eye disease will treated with traditional methods of MGD	Procedure: pharmacological therapy & Eyelid hygiene traditional methods of MGD treatment as Eyelid hygiene, topical preservative free lubricant, topical & systemic antibiotics & anti-inflammatory agent

Arm

Intervention/Treatment

Active Comparator: IRPL Therapy

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

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.

Active Comparator: Non IRPL Therapy

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

Procedure: pharmacological therapy & Eyelid hygiene

traditional methods of MGD treatment as Eyelid hygiene, topical preservative free lubricant, topical & systemic antibiotics & anti-inflammatory agent

Outcome Measures

Primary Outcome Measures

Non-invasive tear film break up time [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
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 Lipid layer thickness [Within 1 month after completion of 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
Change in Meibomian glands % loss grading [Within 1 month after completion of 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.