Feasibility of IPL Combined With RF for Treatment of DED Due to MGD
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|ClinicalTrials.gov Identifier: NCT05487547|
Recruitment Status : Recruiting
First Posted : August 4, 2022
Last Update Posted : August 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Disease Meibomian Gland Dysfunction||Device: IPL_RF_MGX||Not Applicable|
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hand, several researchers reported that application of RF around the eyelids provide immediate relief of DED symptoms (unpublished observations: Dr.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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
intense pulsed light followed by Radiofrequency followed by meibomian gland expression
- 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.
- OSDI [ Time Frame: 4 weeks after the 4th treatment session ]Ocular Surface Disease Index questionnaire
- 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.
- 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.
- 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
- 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
- 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
- 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).
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
|Contact: Haya Hamza, B.Scemail@example.com|
|United States, New York|
|Manhattan Face and Eye clinic||Recruiting|
|New York, New York, United States, 10019|
|Contact: James Chelnis, MD firstname.lastname@example.org|
|United States, North Carolina|
|Carolina Eye Doctors||Recruiting|
|Harrisburg, North Carolina, United States, 28075|
|Contact: Chantel Garcia, OD email@example.com|
|Principal Investigator:||James Chelnis, MD||Manhattan Face and Eye|
|Principal Investigator:||Chantel Garcia, OD||Carolina Eye Doctors|