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IPL_RF_MGX for Meibomian Gland Dysfunction

Manhattan Face and Eye clinic, New York, NY
Targeting 3 different conditionsIPL_RF_MGXN/AWaitlist AvailableLed by Chantel Garcia, ODResearch Sponsored by Lumenis Ltd.

Study Summary

This trial is testing a new treatment for dry eye disease that uses a combination of light and radiofrequency energy. The goal is to see if it is safe and effective.

Eligible Conditions
  • Meibomian Gland Dysfunction
  • Dry Eye Syndrome

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have moderate to severe dry eye.
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You have skin type I-IV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after the 4th treatment session
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after the 4th treatment session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
modified meibomian gland score (mMGS)
Secondary outcome measures
Eyelid appearance
Meibography
NIBUT
+2 more
Other outcome measures
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
35 Previous Clinical Trials
1,180 Total Patients Enrolled
4 Trials studying Meibomian Gland Dysfunction
176 Patients Enrolled for Meibomian Gland Dysfunction
Chantel Garcia, ODPrincipal InvestigatorCarolina Eye Doctors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count for this investigation?

"Correct. According to clinicaltrials.gov, this research endeavour is currently in the process of recruiting volunteers; it was posted on July 21st 2022 and most recently amended on August 1st 2022. The study necessitates 30 patients between two separate sites."

Answered by AI

Is this research endeavor accepting participants that are above the age of 40?

"The criteria for enrollment for this trial requires that participants are between 22 and 85 years of age."

Answered by AI

Is it possible to become an enrollee in this clinical trial?

"30 participants with meibomian gland dysfunction between 22 and 85 years old will be admitted in this trial. It is essential that these individuals are literate, possess moderate to severe dry eye symptoms (OSDI score ≥ 23), demonstrate MGD signs during biomicroscopy, have a mMGS value of 12 or higher for their lower eyelids, agree to comply with the conditions set by the study protocol, and fall within Fitzpatrick skin type I-IV."

Answered by AI

Are there still open enrollment slots in this investigation?

"Evidenced by the clinicaltrials.gov website, this study is still recruiting participants. The original posting of the trial was on July 21st 2022 and a recent update occurred on August 1st 2022."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Manhattan Face and Eye clinic
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Feasibility of IPL Combined With RF for Treatment of DED Due to MGD
2022. "Feasibility of IPL Combined With RF for Treatment of DED Due to MGD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05487547.
~14 spots leftby Nov 2024
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