MedTrace Logo

Effectiveness and Safety of Intense Pulsed Light in Patients With Meibomian Gland Dysfunction

NCT03518398 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2019-06-19

No results posted yet for this study

Summary

Meibomian gland dysfunction (MGD) is one of the most common causes of dry eye diseases. Over the past decade, several treatment options in MGD have been extensively studied including warm compression, lid hygiene, ocular lubricants, forceful expression, LipiFlow thermal pulsation system, intraductal probing, debridement scaling and intense pulsed light (IPL). IPL is a broad spectrum, non-coherent and polychromatic light source with a wavelength spectrum of 500-1200 nm. It can be filtered to allow only a range of wavelengths to be emitted. Different wavelength makes different depth of tissue to absorb a specific light energy. Intense pulsed light (IPL) has been widely used in dermatology as a therapeutic tool for removal of hypertrichosis, benign cavernous hemangioma, benign venous malformations, telangiectasia, port-wine stain and pigmented lesions. Concurrent ocular surface improvements have been observed in patients undergone IPL treatment. Very few prospective clinical trials showed that subjective dry eye symptoms decreased and some of the dry eye signs also improved. Nonetheless, there is still inconsistency in the efficacy of IPL among these studies. Biomarkers, specifically cytokines, in dry eye diseases have been studied to some extent. Moreover, the change in ocular surface inflammatory cytokines in patients with MGD after IPL treatment is unclear.

The investigators proposed a prospective randomized double-masked sham-controlled clinical trial to investigate the efficacy and safety of intense pulse light in MGD patients.

Conditions

  • Meibomian Gland Dysfunction (Disorder)
  • Dry Eye Syndromes

Interventions

DEVICE

Intense Pulsed Light

E\> Eye (E-SWIN, Paris, France) IPL machine

COMBINATION_PRODUCT

Standard treatment

warm compression, lid scrub and non-preservative ocular lubricants

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Yonrawee Piyacomn, MD · Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2019-04-02
Completion
2019-04-02

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03518398 on ClinicalTrials.gov