Effectiveness and Safety of High Frequency Electrotherapy in Patients With Meibomian Gland Dysfunction : Randomized Controlled Trial

Chulalongkorn University1 site in 1 country80 target enrollmentDecember 2021

ConditionsMeibomian Gland Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Meibomian Gland Dysfunction
Sponsor: Chulalongkorn University
Enrollment: 80
Locations: 1
Primary Endpoint: non-invasive tear break-up time (NITBUT)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective randomized double-masked sham-controlled clinical trial to determine the clinical improvement, safety and mechanism of action by evaluation inflammatory cytokine, and amount of bacteria and demodex, after high frequency electrotherapy or called quantum molecular resonance treatment in patients with meibomian gland dysfunction.

Detailed Description

The Rexon-eye is quantum molecular resonance device which was published in previous study that could treat meibomian gland dysfunction. Participants in this study will have Rexon-eye treatment at baseline (after recording of baseline characteristics and giving and inform consent), day 7, day 14, day 21. The evaluation for most parameter except for safety parameter will be recorded at baseline, 1 month after last treatment, and 2 mont after last treatment. Safety parameter will be recorded in all 4 follow-ups. During study, all participant will instructed to use same artificial tears for four time a day.

Registry

clinicaltrials.gov

Start Date

December 2021

End Date

April 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chulalongkorn University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able to read, understand and sign an informed consent form
•\> 18years of age
•Able and willing to comply with the treatment/follow-up schedule and requirements
•Presence of meibomian gland on each lower eyelid's meibography
•Current diagnosis of stage 1-4 of MGD in both eyes, according to the International Workshop on Meibomian Gland Dysfunction: Report of the Subcommittee on Management and Treatment of Meibomian Gland Dysfunction

Exclusion Criteria

•Contact lens wearer within the past 1 month and throughout the study
•Recent ocular surgery or eyelid surgery within the past 6 months
•Neuro-paralysis in the planned treatment area within the past 6 months
•Current use of punctal plugs
•Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
•Uncontrolled infections or uncontrolled immunosuppressive diseases
•Subjects who have undergone refractive surgery within the past 6 months
•Patients who had ocular infection within 6 months
•Pregnancy and lactation
•Any condition revealed during the eligibility screening process whereby the physician deems the subject inappropriate for this study

Outcomes

Primary Outcomes

non-invasive tear break-up time (NITBUT)

Time Frame: 2 month after last treatment (3 month from baseline)

Change from baseline NITBUT at 2 month after last treatment

Secondary Outcomes

Ocular Surface Index Score scored (OSDI score)(2 month after last treatment (3 month from baseline))
Lid meibography grade (upper and lower lid)(2 month after last treatment (3 month from baseline))
meibum expressibility grade(2 month after last treatment (3 month from baseline))
Tear osmole(1 month after last treatment (2 month from baseline))
Bulbar conjunctiva hyperaemia (graded by Janvis score)(2 month after last treatment (3 month from baseline))
Tear cytokine level (Interleukin-6, Interferon-gamma, Interleukin-1RA)(1 month after last treatment (2 month from baseline))
Lid margin thickening grade(2 month after last treatment (3 month from baseline))
Lid margin notching grade(2 month after last treatment (3 month from baseline))
meibomian gland cupping grade(2 month after last treatment (3 month from baseline))
meibum quality grade(2 month after last treatment (3 month from baseline))
Tear meniscus height(2 month after last treatment (3 month from baseline))
TFLLT (Tear film lipid layer thickness)(2 month after last treatment (3 month from baseline))
Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)(2 month after last treatment (3 month from baseline))
Incidence of adverse event(at every visit after treatment (baseline, day7, day14, day21))
Lid margin telangiectasia(2 month after last treatment (3 month from baseline))
best spectacle corrected visual acuity (logMAR)(at every visit before treatment (baseline, day7, day14, day21))
uncorrected visual acuity (logMAR)(at every visit before treatment (baseline, day7, day14, day21))
Amount of bacteria culture from lid margin and meibum (colony forming unit)(1 month after last treatment (2 month from baseline))
Schirmer test (not use anaesthesia, mm)(2 month after last treatment (3 month from baseline))