Intense Pulsed Light in Meibomian Gland Dysfunction

NCT05089591 | Unknown DMC

• 1 other identifier: IPL
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• Difference Meibum quality score and expressibility between both eyes during the 6-month visit

  6-months visit

Secondary Outcomes (3)

• 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

• Change of Ocular Surface Disease Index (OSDI) score during the study period

  6 months

Study Arms (2)

Study eyes

ACTIVE COMPARATOR

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

Device: Intense Pulsed Light therapy

Control eyes

SHAM COMPARATOR

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

Device: Sham Treatment

Interventions

Intense Pulsed Light therapy DEVICE

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.

Study eyes

Sham Treatment DEVICE

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.

Control eyes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18 years
• Presence of meibomian gland dysfunction at any stage
• Presence of meibomian glands on each lower eyelid's Meibography

You may not qualify if:

• 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

Sponsors & Collaborators

• Prim. Prof. Dr. Oliver Findl, MBA: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

RECRUITING

Related Publications (1)

• Schlatter A, Palkovits S, Amir-Asgari S, Ruiss M, Zeilinger J, Rotter A, Schmidl D, Findl O. Safety and efficacy of a novel intense pulsed light system in patients with meibomian gland dysfunction: a randomized, double-masked, intra-individual controlled study. Int Ophthalmol. 2025 Jun 16;45(1):246. doi: 10.1007/s10792-025-03622-2.

  PMID: 40524073 DERIVED

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Central Study Contacts

Stefan Palkovits, MD, PhD

CONTACT

+43 (0)1 91021- 57564; office@viros.at

Andreas Schlatter, MD

CONTACT

+43 (0)1 91021- 57564; office@viros.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prim. Univ. Prof. Dr. Oliver Findl, MBA

Model Details: Bilateral comparison

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 22, 2021
• Study Start: October 20, 2021
• Primary Completion: October 20, 2022
• Study Completion: November 1, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

AU (1)