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

NCT ID: NCT05487547

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-21
• Study Completion Date: 2022-12-28

Brief 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hand, several researchers reported that application of RF around the eyelids provide immediate relief of DED symptoms (unpublished observations: Dr.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.

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Conditions

Dry Eye Disease; Meibomian Gland Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm

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.

Group Type: EXPERIMENTAL

IPL_RF_MGX

Intervention Type: DEVICE

intense pulsed light followed by Radiofrequency followed by meibomian gland expression

Interventions

IPL_RF_MGX

intense pulsed light followed by Radiofrequency followed by meibomian gland expression

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Chelnis, MD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Face and Eye

Chantel Garcia, OD

Role: PRINCIPAL_INVESTIGATOR

Carolina Eye Doctors

Locations

Manhattan Face and Eye clinic

New York, New York, United States

Carolina Eye Doctors

Harrisburg, North Carolina, United States

Countries

United States

Other Identifiers

LUM-VBU-NUERA-OPT-22-01

Identifier Type: -

Identifier Source: org_study_id