Intense Pulsed Light in Meibomian Gland Dysfunction

Not Applicable

• Conditions: Meibomian Gland Dysfunction
• Interventions: Device: Intense Pulsed Light therapy; Device: Sham Treatment

• Registration Number: NCT05089591
• Lead Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-20
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Last Update Submitted: 2021-10-20
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22
• Primary Completion: 2022-10-20
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study eyes	Intense Pulsed Light therapy	Study eye receives the standard energy dose as recommended by the manufacturer (between 8 and 12J/cm2, in accordance with the manufacturer's recommendations).
Control eyes	Sham Treatment	The control eye is treated using low energy dose energy (1J/ cm2) as sham treatment, ensuring blinding of the respective patient.

Primary Outcome Measures

Name	Time	Method
Difference Meibum quality score and expressibility between both eyes during the 6-month visit	6-months visit

Secondary Outcome Measures

Name	Time	Method
Change of Ocular Surface Disease Index (OSDI) score during the study period	6 months
Comparison of dry eye related parameters between both eyes (tear film break up time, Oxford Staining)	6 months
Change of dry eye related parameters during the study period in the study eye (tear film break up time, Oxford Staining)	6 months

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery; 🇦🇹 Vienna, Austria