IPL + RF for Dry Eye Syndrome

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for people with dry eye disease caused by Meibomian gland dysfunction (MGD). The treatment, IPL_RF_MGX, combines intense pulsed light (IPL) and radiofrequency (RF) to evaluate its safety and effectiveness. Participants will receive four treatments over two months, focusing on the area around the eyes. This trial may suit those who regularly experience moderate to severe dry eyes and have been diagnosed with MGD. As an unphased trial, it offers an opportunity to explore innovative treatment options for dry eye disease.

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 prior data suggests that this combination therapy is safe for treating Dry Eye Disease?

Research has shown that using intense pulsed light (IPL) with radiofrequency (RF) is generally safe for treating dry eye disease caused by meibomian gland dysfunction. One study found that this combination improves symptoms more effectively than using either treatment alone. Although specific safety details aren't mentioned, both IPL and RF are used in other treatments and are generally considered safe. These treatments might cause mild side effects, such as temporary redness or warmth in the treated area. Always consult your doctor to determine if this treatment is suitable for you.12345

Why are researchers excited about this trial?

Researchers are excited about the IPL_RF_MGX treatment for dry eye disease due to meibomian gland dysfunction because it combines three innovative therapies into one regimen. Unlike standard treatments like artificial tears, warm compresses, or eyelid scrubs, this approach uses intense pulsed light (IPL) on the malar region and radiofrequency (RF) around the eyes, which may improve the function of the meibomian glands more effectively. The addition of meibomian gland expression (MGX) further enhances gland clearance. This combination targets the underlying causes of meibomian gland dysfunction, offering a potentially more comprehensive and longer-lasting solution compared to conventional methods.

What evidence suggests that this combination therapy might be an effective treatment for Dry eye disease?

Research has shown that combining intense pulsed light (IPL), radiofrequency (RF), and meibomian gland expression (MGX) can improve dry eye symptoms caused by meibomian gland issues. In this trial, participants will receive this combination treatment, which has provided greater symptom relief compared to past data. A review of past cases revealed that 89% of patients experienced significant relief from dry eye symptoms after receiving IPL and MGX. Studies have also found that IPL-MGX is more effective than MGX alone. Additionally, RF has proven to safely and effectively ease dry eye symptoms. Overall, these treatments together have shown promise in improving the condition.13678

Who Is on the Research Team?

JC

James Chelnis, MD

Principal Investigator

Manhattan Face and Eye

CG

Chantel Garcia, OD

Principal Investigator

Carolina Eye Doctors

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

  • IPL_RF_MGX
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Study armExperimental Treatment1 Intervention

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+

Citations

Multi-Frequency RF Combined with Intense Pulsed Light ...Combination of multi-frequency RF and IPL+MGX improves signs and symptoms of MGD. In comparison to a historical control, improvements were generally larger.
Intense pulsed light for treatment of dry eye disease"The combination of IPL and MGX can significantly improve dry eye symptoms — in this retrospective analysis, in 89% of patients — and meibomian ...
Feasibility of IPL Combined With RF for Treatment of DED ...Each treatment will consist of IPL administered on the malar region, followed by RF administered around the eye, followed by Meibomian gland expression (MGX).
Efficacy of intense pulsed light and meibomian gland ...Conclusions: IPL-MGX is safer and more efficacious as compared to the MGX alone in the treatment of patients with meibomian gland dysfunction-related dry eye.
Transcutaneous Radiofrequency-mediated Meibomian ...This pilot study examined the safety and efficacy of RF-mediated meibomian gland expression for the treatment of dry eye symptoms. The data supports the ...
Comparison of clinical outcomes between intense pulsed ...Our study compared treatment efficacy between cut-off and notch filters in intense pulsed light (IPL) therapy for meibomian gland dysfunction (MGD)
LipiFlow or intense pulsed light? A systematic review and ...Our analysis indicated that IPL therapy resulted in a greater decrease in SPEED score compared to controls (MD: -2.9; 95% CI [-5.18, -0.64] p = 0.01). However, ...
Feasibility of IPL Combined With RF for Treatment of DED ...The purpose of this single-arm pilot study is to evaluate the feasibility and safety of combination therapy of IPL and RF for treatment of DED due to MGD. As ...
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