Intense Regulated Pulse Light Therapy in Dry Eye Disease

NCT ID: NCT05553561

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IRPL Therapy

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

Group Type ACTIVE_COMPARATOR

IPRL device

Intervention Type PROCEDURE

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.

Non IRPL Therapy

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

Group Type ACTIVE_COMPARATOR

pharmacological therapy & Eyelid hygiene

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

pharmacological therapy & Eyelid hygiene

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Rofaida Mostafa Mansour Serag EL Deen

Ophthalmologist at Menoufia university hospitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Monoufia university

Menoufia, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rofaida Mostafa Mansour, Master degree in ophthalmology

Role: CONTACT

01000502442

Other Identifiers

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7/2022OPHT23

Identifier Type: -

Identifier Source: org_study_id

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