Clinical trial NCT05089591: Intense Pulsed Light in Meibomian Gland Dysfunction
Official title: Efficacy of Intense Pulsed Light Treatment in Patients With Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bilateral comparison
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference Meibum quality score and expressibility between both eyes during the 6-month visit
timeFrame: 6-months visit
Secondary outcomes:
measure: Comparison of dry eye related parameters between both eyes (tear film break up time, Oxford Staining)
timeFrame: 6 months
measure: Change of dry eye related parameters during the study period in the study eye (tear film break up time, Oxford Staining)
timeFrame: 6 months
measure: Change of Ocular Surface Disease Index (OSDI) score during the study period
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery
Study officials:
References: