Intense Pulsed Light in Meibomian Gland Dysfunction

Meibomian Gland Dysfunction Clinical Trial

Official title:

Efficacy of Intense Pulsed Light Treatment in Patients With Meibomian Gland Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05089591
• Other study ID #: IPL
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2021
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Stefan Palkovits, MD, PhD
• Phone: +43 (0)1 91021- 57564
• Email: office[@]viros.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: November 1, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age older than 18 years

• Presence of meibomian gland dysfunction at any stage

• Presence of meibomian glands on each lower eyelid's Meibography

Exclusion Criteria:

• Fitzpatrick Skin Type VI

• Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)

• Usage of systemic antibiotic therapy

• Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)

• Ocular surgery within prior 3 months

• Ocular injury within prior 3 months

• Ocular herpes of eye or eyelid within prior 3 months

• Active ocular infection

• Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months

• Eyelid abnormalities that affect lid function

• Ocular surface abnormality that may compromise corneal integrity

• Pregnancy

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Prim. Prof. Dr. Oliver Findl, MBA

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference Meibum quality score and expressibility between both eyes during the 6-month visit		6-months visit
Secondary	Comparison of dry eye related parameters between both eyes (tear film break up time, Oxford Staining)		6 months
Secondary	Change of dry eye related parameters during the study period in the study eye (tear film break up time, Oxford Staining)		6 months
Secondary	Change of Ocular Surface Disease Index (OSDI) score during the study period		6 months