We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05487547
Recruitment Status : Recruiting
First Posted : August 4, 2022
Last Update Posted : August 4, 2022
Sponsor:
Information provided by (Responsible Party):
Lumenis Be Ltd.

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).

Condition or disease Intervention/treatment Phase
Dry Eye Disease Meibomian Gland Dysfunction Device: IPL_RF_MGX Not Applicable

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hand, several researchers reported that application of RF around the eyelids provide immediate relief of DED symptoms (unpublished observations: Dr.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

.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of IPL Combined With RF for Treatment of DED Due to MGD
Actual Study Start Date : July 21, 2022
Estimated Primary Completion Date : November 27, 2022
Estimated Study Completion Date : December 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: 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.
Device: IPL_RF_MGX
intense pulsed light followed by Radiofrequency followed by meibomian gland expression




Primary Outcome Measures :
  1. modified meibomian gland score (mMGS) [ Time Frame: 4 weeks after the 4th treatment session ]
    15 meibomian glands along the lower lid (5 nasal + 5 central + 5 temporal) will be gently expressed with the dedicated expression forceps. Each gland will be scored 0 to 3, as follows: 0 = clear liquid meibum; 1 = cloudy liquid meibum; 2 = inspissated meibum; 3 = blocked). mMGS will be evaluated as the sum of scores for these 15 glands.


Secondary Outcome Measures :
  1. OSDI [ Time Frame: 4 weeks after the 4th treatment session ]
    Ocular Surface Disease Index questionnaire

  2. Eyelid appearance [ Time Frame: 4 weeks after the 4th treatment session ]
    Eyelid appearance will be assessed with biomicroscopy at the slit lamp. Five features of the eyelids will be scored: lid margin vascularity, eyelid thickness, loss of eyelashes, conjunctival injection, and plugging of meibomian gland orifices. Each feature will be scored using a 4 point grading system: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.

  3. Number of expressible glands [ Time Frame: 4 weeks after the 4th treatment session ]
    Glands along the upper and lower lids will be squeezed with a dedicated expression forceps. The number of glands expressing any meibum (clear liquid, cloudy liquid, or inspissated) will be counted, per each eyelid separately.

  4. NIBUT [ Time Frame: 4 weeks after the 4th treatment session ]
    The non-invasive breakup time (NIBUT) will be measured with the tear film analysis feature of the Antares system (CSO). The subject will be asked to maintain his/her eye open, without blinking, in front of a device that will project concentric Placido disks will be projected onto the ocular surface. Mire reflections of these placido disks will be monitored. The first occurrence of image distortion will

  5. Meibography [ Time Frame: 4 weeks after the 4th treatment session ]
    The study investigator will invert the eyelids of the subject, to expose the meibomian glands. After viewing the inverted eyelids with infra-red light illumination using the Antares system (CSO), an infra-red image of the meibomian glands will be captured cand saved. The Antares software will be use to calculate the area of meibomian gland loss


Other Outcome Measures:
  1. Predominant quality of the meibum [ Time Frame: 4 weeks after the 4th treatment session ]
    The predominant quality of the meibum represents the quality of the meibum expressed from the majority of the meibomian glands. This will be assessed using a 4 point grading system: 0 = clear liquid, 1 = cloud liquid, 2 = inspissated, and 3 = no expression

  2. MMP-9 test [ Time Frame: 4 weeks after the 4th treatment session ]
    Presence/Absence of MMP-9 in tear samples will be evaluated with the InflammaDry test (Pathogen Screening, Sarasota, FL).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05487547


Contacts
Layout table for location contacts
Contact: Haya Hamza, B.Sc +972527493696 haya.hamza@lumenis.com

Locations
Layout table for location information
United States, New York
Manhattan Face and Eye clinic Recruiting
New York, New York, United States, 10019
Contact: James Chelnis, MD       drchelnis@manhattanfaceandeye.com   
United States, North Carolina
Carolina Eye Doctors Recruiting
Harrisburg, North Carolina, United States, 28075
Contact: Chantel Garcia, OD       drgarcia@carolinaeyedocs.com   
Sponsors and Collaborators
Lumenis Be Ltd.
Investigators
Layout table for investigator information
Principal Investigator: James Chelnis, MD Manhattan Face and Eye
Principal Investigator: Chantel Garcia, OD Carolina Eye Doctors
Layout table for additonal information
Responsible Party: Lumenis Be Ltd.
ClinicalTrials.gov Identifier: NCT05487547    
Other Study ID Numbers: LUM-VBU-NUERA-OPT-22-01
First Posted: August 4, 2022    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis Sicca
Meibomian Gland Dysfunction
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Eyelid Diseases