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

Completed · Not applicable

Conditions studied: Dry Eye Disease, Meibomian Gland Dysfunction

In brief

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).

Key facts

Study ID

NCT05487547

Run by

Lumenis Be Ltd.

People needed

33

Starts

2022-07-21

Expected to finish

2022-12-28

Last updated by the study team

2023-01-18

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able to read, understand and sign an IC form
• 22 or older
• Self-assessed symptoms are consistent with moderate to severe dry eye (OSDI score ≥ 23)
• Signs of MGD, as detected in biomicroscopy
• Modified Meibomian Gland Score (mMGS) > 12 in the lower eyelid of at least one eye
• Fitzpatrick skin type I-IV
• Subject is willing to comply with all study procedures

You may not qualify if…

• Fitzpatrick skin type V or VI
• Pacemaker
• Any metal implants above the neck, excluding dental implants
• Dry Eye due to Sjogren
• LASIK/SMILE surgery, within 1 year prior to screening
• RK surgery
• Other ocular surgery or eyelid surgery, within 3 months prior to screening
• Recent ocular trauma, within 3 months prior to screening
• Pre-cancerous lesions or skin cancer in the planned treatment area
• Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface
• Uncontrolled infections or uncontrolled immunosuppressive diseases
• Legally blind in either eye worse than 20/200
• Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, Epithelial Basement Membrane Dystrophy (EBMD)
• Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, blepharospasm, Grading staining in the lower third secondary to lagophthalmos, severe trichiasis, and severe ptosis
• Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
• Active sun burn in the treatment area
• Moderate to severely compromised corneal health as assessed by corneal fluorescein staining
• Anterior chamber inflammation
• Corneal edema
• 4 weeks wash out of all prescription eye drops, excluding artificial lubricants
• No more than 75% loss of meibomian glands, as evaluated with meibography, in either lower eyelid
• Any non-prescription product for dry eye, within 1 month from the study, excluding artificial lubricants
• Any condition revealed whereby the investigator deems the subject inappropriate for this study

Where it is running

• Manhattan Face and Eye clinic — New York, New York, United States
• Carolina Eye Doctors — Harrisburg, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.