Intense Pulsed Light in Meibomian Gland Dysfunction

Prim. Prof. Dr. Oliver Findl, MBA

Status: Unknown

Conditions: Meibomian Gland Dysfunction

Treatments: Device: Sham Treatment; Device: Intense Pulsed Light therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05089591

IPL

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Study eyes

Active Comparator group

Description:

Study eye receives the standard energy dose as recommended by the manufacturer (between 8 and 12J/cm2, in accordance with the manufacturer's recommendations).

Treatment:

Device: Intense Pulsed Light therapy

Control eyes

Sham Comparator group

Description:

The control eye is treated using low energy dose energy (1J/ cm2) as sham treatment, ensuring blinding of the respective patient.

Treatment:

Device: Sham Treatment