33 Participants Needed

Feasibility of IPL Combined With RF for Treatment of DED Due to MGD

Recruiting at 1 trial location
HH
Overseen ByHaya Hamza, B.Sc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires a 4-week period without using any prescription eye drops, except for artificial lubricants. Non-prescription products for dry eye should not be used within 1 month of the study, except for artificial lubricants.

What is the purpose of this trial?

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.

Research Team

JC

James Chelnis, MD

Principal Investigator

Manhattan Face and Eye

CG

Chantel Garcia, OD

Principal Investigator

Carolina Eye Doctors

Eligibility Criteria

Inclusion Criteria

22 or older
You have moderate to severe dry eye.
Subject is able to read, understand and sign an IC form
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 treatments at 2-week intervals, consisting of IPL, RF, and MGX

8 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Treatment Details

Interventions

  • IPL_RF_MGX
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lumenis Ltd.

Lead Sponsor

Trials
24
Recruited
670+

Lumenis Be Ltd.

Lead Sponsor

Trials
39
Recruited
1,500+
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