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Feasibility of IPL Combined With RF for Treatment of DED Due to MGD
N/A
Waitlist Available
Led By Chantel Garcia, OD
Research Sponsored by Lumenis Ltd.
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 4 weeks after the 4th treatment session
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for people with dry eyes caused by gland issues. The treatment uses special light pulses and radio waves to reduce swelling and warm the eyelids, providing both quick relief and long-term improvement.
Eligible Conditions
- Meibomian Gland Dysfunction
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks after the 4th treatment session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after the 4th treatment session
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
modified meibomian gland score (mMGS)
Secondary study objectives
Eyelid appearance
Meibography
NIBUT
+2 moreOther study objectives
MMP-9 test
Predominant quality of the meibum
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study armExperimental Treatment1 Intervention
Subjects will receive 4 treatments at 2-weeks intervals. Each treatment will consist of IPL administered on the malar region, followed by RF administered around the eye, followed by Meibomian gland expression (MGX). Follow-up will be conducted at 4 weeks after the 4th treatment session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IPL_RF_MGX
2022
N/A
~40
Find a Location
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
37 Previous Clinical Trials
1,380 Total Patients Enrolled
4 Trials studying Meibomian Gland Dysfunction
176 Patients Enrolled for Meibomian Gland Dysfunction
Chantel Garcia, ODPrincipal InvestigatorCarolina Eye Doctors
James Chelnis, MDPrincipal InvestigatorManhattan Face and Eye
2 Previous Clinical Trials
1,084 Total Patients Enrolled