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Intense Regulated Pulse Light Therapy in Dry Eye Disease

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05553561
Enrollment
34
Registered
2022-09-23
Start date
2023-01-01
Completion date
2023-12-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Keywords

IPL therapy, IRPL therapy, Dry eye, MGD

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.

Interventions

PROCEDUREIPRL 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.

PROCEDUREpharmacological therapy & Eyelid hygiene

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

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Non-invasive tear film break up timebefore treatmentassessment of tear film through MediWorks device attached to the slitlamp
Change in Non-invasive tear film break up timeWithin 1 month after completion of treatmentassessment of tear film through MediWorks device attached to the slitlamp
Tear Meniscus Heightbefore treatmentassessment of tear film through MediWorks device attached to the slitlamp
Change in Tear Meniscus HeightWithin 1 month after completion of treatmentassessment of tear film through MediWorks device attached to the slitlamp
Lipid layer thicknessbefore treatmentassessment of tear film through MediWorks device attached to the slitlamp
Change in Lipid layer thicknessWithin 1 month after completion of treatmentassessment of tear film through MediWorks device attached to the slitlamp
Meibomian glands % loss gradingbefore treatmentassessment of tear film through MediWorks device attached to the slitlamp
Change in Meibomian glands % loss gradingWithin 1 month after completion of treatmentassessment of tear film through MediWorks device attached to the slitlamp
patient's quality of life affectionbefore treatmentThe 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 affectionWithin 1 month after completion of treatmentThe 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.

Countries

Egypt

Contacts

Primary ContactRofaida Mostafa Mansour, Master degree in ophthalmology
drrofaidamostafa1989@gmail.com01000502442

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026