Effectiveness and Safety of High Frequency Electrotherapy in Patients With Meibomian Gland Dysfunction

Chulalongkorn University80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Meibomian Gland Dysfunction

Interventions

Rexon-eyeDEVICE

a technique in which low-intensity, high-frequency (a spectrum of frequencies ranging from 4 MHz to 64 MHz) electric currents are administered to a biological tissue through contact electrodes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able to read, understand and sign an informed consent form 2. \> 18years of age 3. Able and willing to comply with the treatment/follow-up schedule and requirements 4. Presence of meibomian gland on each lower eyelid's meibography 5. 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: 1. Contact lens wearer within the past 1 month and throughout the study 2. Recent ocular surgery or eyelid surgery within the past 6 months 3. Neuro-paralysis in the planned treatment area within the past 6 months 4. Current use of punctal plugs 5. Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area 6. Uncontrolled infections or uncontrolled immunosuppressive diseases 7. Subjects who have undergone refractive surgery within the past 6 months 8. Patients who had ocular infection within 6 months 9. Pregnancy and lactation 10. Any condition revealed during the eligibility screening process whereby the physician deems the subject inappropriate for this study 11. Declared legally blind in one eye 12. Lipiflow treatment, or any equivalent treatments, within the past 12 months

Locations (1)

Chulalongkorn University

Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

non-invasive tear break-up time (NITBUT)

Change from baseline NITBUT at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

non-invasive tear break-up time (NITBUT)

Change from baseline NITBUT at 2 month after last treatment

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

Secondary Outcomes

Ocular Surface Index Score scored (OSDI score)

Change from baseline OSDI score at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Lid margin thickening grade

Change from baseline Lid margin thickening grade at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Lid margin notching grade

Change from baseline Lid margin notching grade at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Lid margin telangiectasia

Change from baseline Lid margin telangiectasia at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

meibomian gland cupping grade

Change from baseline meibomian gland cupping grade at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Lid meibography grade (upper and lower lid)

Central Contacts

Lita Uthaithammarat, MD

CONTACT

66867836002 lita.t@chula.ac.th

Ngamjit Kasetsuwan, MD

CONTACT

ngamjitk@gmail.com

Data from ClinicalTrials.gov

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Change from baseline Lid meibography grade at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

meibum expressibility grade

change from baseline meibum expressibility grade at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

meibum quality grade

Change from baseline meibum quality grade at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Amount of bacteria culture from lid margin and meibum (colony forming unit)

Change from baseline meibum quality grade at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Tear cytokine level (Interleukin-6, Interferon-gamma, Interleukin-1RA)

Change from baseline Tear cytokine level at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Tear osmole

Change from baseline Tear osmole level at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Schirmer test (not use anaesthesia, mm)

Change from baseline schirmer test at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Tear meniscus height

Change from baseline Tear meniscus height at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

TFLLT (Tear film lipid layer thickness)

Change from baseline TFLLT at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Bulbar conjunctiva hyperaemia (graded by Janvis score)

Change from baseline Bulbar conjunctiva hyperaemia at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)

Change from baseline corneal and conjunctival stain at 1 month after last treatment

Time frame: 1 month after last treatment (2 month from baseline)

Incidence of adverse event

Time frame: at every visit after treatment (baseline, day7, day14, day21)

best spectacle corrected visual acuity (logMAR)

Any change from baseline best spectacle corrected visual acuity (logMAR) at day7, day14, and day 21

Time frame: at every visit before treatment (baseline, day7, day14, day21)

uncorrected visual acuity (logMAR)

Any change from baseline uncorrected visual acuity (logMAR) at day7, day14, and day 21

Time frame: at every visit before treatment (baseline, day7, day14, day21)

Ocular Surface Index Score scored (OSDI score)

Change from baseline OSDI score at 2 month after last treatment

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

Lid margin thickening grade

Change from baseline Lid margin thickening grade at 2 month after last treatment

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

Lid margin notching grade

Change from baseline Lid margin notching grade at 2 month after last treatment

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

Lid margin telangiectasia

Change from baseline Lid margin telangiectasia at 2 month after last treatment

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

meibomian gland cupping grade

Change from baseline meibomian gland cupping grade at 2 month after last treatment

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

Lid meibography grade (upper and lower lid)

Change from baseline Lid meibography grade at 2 month after last treatment

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

meibum expressibility grade

change from baseline meibum expressibility grade at 2 month after last treatment

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

meibum quality grade

Change from baseline meibum quality grade at 2 month after last treatment

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

Schirmer test (not use anaesthesia, mm)

Change from baseline schirmer test at 2 month after last treatment

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

Tear meniscus height

Change from baseline Tear meniscus height at 2 month after last treatment

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

TFLLT (Tear film lipid layer thickness)

Change from baseline TFLLT at 2 month after last treatment

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

Bulbar conjunctiva hyperaemia (graded by Janvis score)

Change from baseline Bulbar conjunctiva hyperaemia at 2 month after last treatment

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

Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)

Change from baseline corneal and conjunctival stain at 2 month after last treatment

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