IPL_RF_MGX for Meibomian Gland Dysfunction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Manhattan Face and Eye clinic, New York, NY
Meibomian Gland Dysfunction+4 More
IPL_RF_MGX - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this single-arm pilot study is to evaluate the feasibility and safety of combination therapy of intense pulsed light (IPL) and (Radiofrequency) RF for treatment of Dry eye disease (DED) due to Meibomian gland dysfunction (MGD).

Eligible Conditions

  • Meibomian Gland Dysfunction
  • Dry Eye Syndromes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 4 weeks after the 4th treatment session

Week 4
Eyelid appearance
MMP-9 test
Meibography
NIBUT
Number of expressible glands
OSDI
Predominant quality of the meibum
modified meibomian gland score (mMGS)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Study arm
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: IPL_RF_MGX · No Placebo Group · N/A

Study arm
Device
Experimental Group · 1 Intervention: IPL_RF_MGX · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks after the 4th treatment session
Closest Location: Manhattan Face and Eye clinic · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Meibomian Gland Dysfunction
0 CompletedClinical Trials

Who is running the clinical trial?

Lumenis Ltd.Lead Sponsor
23 Previous Clinical Trials
641 Total Patients Enrolled
4 Trials studying Meibomian Gland Dysfunction
176 Patients Enrolled for Meibomian Gland Dysfunction
Lumenis Be Ltd.Lead Sponsor
27 Previous Clinical Trials
701 Total Patients Enrolled
4 Trials studying Meibomian Gland Dysfunction
176 Patients Enrolled for Meibomian Gland Dysfunction
James Chelnis, MDPrincipal InvestigatorManhattan Face and Eye
2 Previous Clinical Trials
2,000 Total Patients Enrolled
Chantel Garcia, ODPrincipal InvestigatorCarolina Eye Doctors

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have moderate to severe dry eye.
You have skin type I-IV.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.