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MGX and Intense Pulsed Light Treatment (IPL) for Dry Eye Syndrome

N/A
Waitlist Available
Led By Joanne F Shen
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long term improvement of symptoms for patients by improving the quality of meibum, increasing meibum flow, improving tear film stability and decreasing inflammation. Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation, topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers, intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses, among other. Despite this variety of symptoms, patients often do not experience complete or long term relief of symptoms. Forced meibomian gland expression (MGX) has been shown to be an effective method of rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are forcefully compressed to express gland contents. Research has shown improvement in patient symptoms with the use of MGX. Intense pulsed light (IPL) have been used in dermatology to treat various conditions. Patients with DED who have tried other therapies and found no relief, often resort to IPL as a last resort. Research has shown IPL alone may be effective in improving patient symptoms. In addition, such studies have failed to show significant adverse events with the use of IPL. Here, we propose a prospective, randomized, case controlled clinical pilot study to examine the efficacy for both subjective and objective measures. 20 patients with DED will be recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL. Objective measures will include tear cytokine levels, impression cytology, meibography, tear osmolarity and others. Subjective measures will include quality of life screening tools. We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective dry eye symptoms and objective measures. Given the lack of adverse effects reported in the literature, we do not anticipate adverse effects in our study. Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no contact with subjects or biospecimens.

Eligible Conditions
  • Eye Redness
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score
Secondary study objectives
Change in Meibomian Glands Open - Left Lower Lid
Change in Meibomian Glands Open - Right Lower Lid

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MGX and Intense Pulsed Light Treatment (IPL)Experimental Treatment2 Interventions
Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX)
Group II: Meibomian Gland Expression (MGX)Active Control1 Intervention
Treatment with 4 visits and 4 treatments of MGX only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intense Pulsed Light Treatment (IPL)
2017
N/A
~20
Meibomian Gland Expression
2017
N/A
~30

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,322 Previous Clinical Trials
3,060,033 Total Patients Enrolled
Joanne F ShenPrincipal InvestigatorMayo Clinic
~2 spots leftby Oct 2025