NCT05487547

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In the past several years, a large number of studies have demonstrated that several sessions of IPL followed by MGX lead to a long-term reduction in signs and symptoms of DED due to MGD, however benefits for the patient are expected only after 2 or 3 sessions. On the other hand, several researchers reported that application of RF around the eyelids provide immediate relief of DED symptoms (unpublished observations: Dr. Chantel Garcia). The efficacy of RF for reduction of DED signs and symptoms was also demonstrated in two clinical studies and one animal model of obstructive MGD. Despite the small number of studies with RF, these preliminary results suggest that the combination of IPL, MGX and RF could provide immediate symptomatic relief together with long-term improvement of signs and symptoms of DED. In addition, combination therapy might be useful to increase the efficacy of monotherapy RF or monotherapy IPL. 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 far as we know this is the first study of its kind. Results of this current study will be useful to choose the most effective outcome measures, to estimate the risk to benefit ratio, and to anticipate the effect size. In the future, such information will be essential for evaluating the merits of this approach, by designing a powered and randomized controlled study. .

Conditions

• Dry Eye Disease
• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DEVICE	IPL_RF_MGX	intense pulsed light followed by Radiofrequency followed by meibomian gland expression

Timeline

• Start date: 2022-07-21
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2022-08-04
• Last updated: 2023-01-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study