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Intense Pulsed Light in Meibomian Gland Dysfunction

NCT05089591 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-10-22

No results posted yet for this study

Summary

Meibomian gland dysfunction (MGD) is a major cause of dry eye disease (DED). Up to 86% of patients suffering from DED also show signs of MGD. Traditional treatment of MGD is based on eye lid hygiene and massage in combination with intensive usage of lubricants.

Recently, a novel technology the intense pulsed light (IPL) therapy was introduced, which shows promising results in patients with meibomian gland dysfunction. Originating from field of dermatology, subjecting improvement of dry eye symptoms was recognized after the treatment of facial rosacea using IPL. Different hypotheses exist how IPL treatment might improve the situation in the dry eye patient. Warming of the eyelid, due to the light application and reduction of bacterial load are two possible mode of actions. Further, the used wavelengths in IPL may be modified that the light is only absorbed by oxygenated haemoglobin, which lead to an obliteration of telangiectasia and reduced inflammation on the lid margin. This principal is applied in the treatment of facial rosacea.

Aim of this study is to investigate the effect of IPL therapy in patients with MGD on dry eye parameters as well as subjective complaints.

Conditions

  • Meibomian Gland Dysfunction

Interventions

DEVICE

Intense Pulsed Light therapy

The LacryStim System is a CE marked device for treatment of meibomian gland dysfunction. It stimulates and reactivates meibomian glands and improves the related dry eye condition. Intense pulsed light is emitted with a light spectrum from 610nm to 1200nm. Each treatment consists of short individual pulses lasting for 4ms separated by a 26ms lasting interval to hinder tissue temperature increase, thermal damage to the skin and inflammatory reaction. During this phase 8 to 12 J / cm2 are delivered. Selection of total energy levels depends on the skin type (Fitzpatrick Skin Types) as recommended by the manufacturer.

DEVICE

Sham Treatment

The fellow eye serves as the control eye. Study eye receives the standard energy dose as recommended by the manufacturer (between 8 and 12J/cm2, in accordance with the manufacturer's recommendations). The control eye is treated using low energy dose energy (1J/ cm2) as sham treatment, ensuring blinding of the respective patient.

Sponsors & Collaborators

  • Prim. Prof. Dr. Oliver Findl, MBA

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2022-10-20
Completion
2022-11-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05089591 on ClinicalTrials.gov