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Intense Regulated Pulse Light Therapy in Dry Eye Disease

Primary Purpose

Dry Eye Disease

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IPRL device
pharmacological therapy & Eyelid hygiene
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease focused on measuring IPL therapy, IRPL therapy, Dry eye, MGD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Monoufia universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IRPL Therapy

Non IRPL Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Non-invasive tear film break up time
assessment of tear film through MediWorks device attached to the slitlamp
Change in Non-invasive tear film break up time
assessment of tear film through MediWorks device attached to the slitlamp
Tear Meniscus Height
assessment of tear film through MediWorks device attached to the slitlamp
Change in Tear Meniscus Height
assessment of tear film through MediWorks device attached to the slitlamp
Lipid layer thickness
assessment of tear film through MediWorks device attached to the slitlamp
Change in Lipid layer thickness
assessment of tear film through MediWorks device attached to the slitlamp
Meibomian glands % loss grading
assessment of tear film through MediWorks device attached to the slitlamp
Change in Meibomian glands % loss grading
assessment of tear film through MediWorks device attached to the slitlamp
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2022
Last Updated
February 7, 2023
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05553561
Brief Title
Intense Regulated Pulse Light Therapy in Dry Eye Disease
Official Title
Therapeutic Effect of Intense Regulated Pulse Light in Patients With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
IPL therapy, IRPL therapy, Dry eye, MGD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IRPL Therapy
Arm Type
Active Comparator
Arm Description
17 patients with moderate to severe evaporative dry eye disease will treated with 3 sessions of IRPL therapy.
Arm Title
Non IRPL Therapy
Arm Type
Active Comparator
Arm Description
17 patients with moderate to severe evaporative dry eye disease will treated with traditional methods of MGD
Intervention Type
Procedure
Intervention Name(s)
IPRL device
Intervention Description
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
Intervention Name(s)
pharmacological therapy & Eyelid hygiene
Intervention Description
traditional methods of MGD treatment as Eyelid hygiene, topical preservative free lubricant, topical & systemic antibiotics & anti-inflammatory agent
Primary Outcome Measure Information:
Title
Non-invasive tear film break up time
Description
assessment of tear film through MediWorks device attached to the slitlamp
Time Frame
before treatment
Title
Change in Non-invasive tear film break up time
Description
assessment of tear film through MediWorks device attached to the slitlamp
Time Frame
Within 1 month after completion of treatment
Title
Tear Meniscus Height
Description
assessment of tear film through MediWorks device attached to the slitlamp
Time Frame
before treatment
Title
Change in Tear Meniscus Height
Description
assessment of tear film through MediWorks device attached to the slitlamp
Time Frame
Within 1 month after completion of treatment
Title
Lipid layer thickness
Description
assessment of tear film through MediWorks device attached to the slitlamp
Time Frame
before treatment
Title
Change in Lipid layer thickness
Description
assessment of tear film through MediWorks device attached to the slitlamp
Time Frame
Within 1 month after completion of treatment
Title
Meibomian glands % loss grading
Description
assessment of tear film through MediWorks device attached to the slitlamp
Time Frame
before treatment
Title
Change in Meibomian glands % loss grading
Description
assessment of tear film through MediWorks device attached to the slitlamp
Time Frame
Within 1 month after completion of treatment
Title
patient's quality of life affection
Description
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.
Time Frame
before treatment
Title
Change in patient's quality of life affection
Description
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.
Time Frame
Within 1 month after completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rofaida Mostafa Mansour, Master degree in ophthalmology
Phone
01000502442
Email
drrofaidamostafa1989@gmail.com
Facility Information:
Facility Name
Monoufia university
City
Menoufia
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Intense Regulated Pulse Light Therapy in Dry Eye Disease

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