Intense Regulated Pulse Light Therapy in Dry Eye Disease

February 7, 2023 updated by: Rofaida Mostafa Mansour Serag EL Deen, Menoufia University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Menoufia, Egypt
        • Recruiting
        • Monoufia university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive tear film break up time
Time Frame: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
before treatment
Change in Non-invasive tear film break up time
Time Frame: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Within 1 month after completion of treatment
Tear Meniscus Height
Time Frame: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
before treatment
Change in Tear Meniscus Height
Time Frame: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Within 1 month after completion of treatment
Lipid layer thickness
Time Frame: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
before treatment
Change in Lipid layer thickness
Time Frame: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Within 1 month after completion of treatment
Meibomian glands % loss grading
Time Frame: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
before treatment
Change in Meibomian glands % loss grading
Time Frame: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Within 1 month after completion of treatment
patient's quality of life affection
Time Frame: 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.
before treatment
Change in patient's quality of life affection
Time Frame: 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.
Within 1 month after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2023

Primary Completion (ANTICIPATED)

July 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (ACTUAL)

September 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7/2022OPHT23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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