Clinical trial NCT05165342: Effectiveness and Safety of High Frequency Electrotherapy in Patients With Meibomian Gland Dysfunction
Official title: Effectiveness and Safety of High Frequency Electrotherapy in Patients With Meibomian Gland Dysfunction : Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: non-invasive tear break-up time (NITBUT)
timeFrame: 1 month after last treatment (2 month from baseline)
measure: non-invasive tear break-up time (NITBUT)
timeFrame: 2 month after last treatment (3 month from baseline)
Secondary outcomes:
measure: Ocular Surface Index Score scored (OSDI score)
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Lid margin thickening grade
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Lid margin notching grade
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Lid margin telangiectasia
timeFrame: 1 month after last treatment (2 month from baseline)
measure: meibomian gland cupping grade
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Lid meibography grade (upper and lower lid)
timeFrame: 1 month after last treatment (2 month from baseline)
measure: meibum expressibility grade
timeFrame: 1 month after last treatment (2 month from baseline)
measure: meibum quality grade
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Amount of bacteria culture from lid margin and meibum (colony forming unit)
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Tear cytokine level (Interleukin-6, Interferon-gamma, Interleukin-1RA)
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Tear osmole
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Schirmer test (not use anaesthesia, mm)
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Tear meniscus height
timeFrame: 1 month after last treatment (2 month from baseline)
measure: TFLLT (Tear film lipid layer thickness)
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Bulbar conjunctiva hyperaemia (graded by Janvis score)
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)
timeFrame: 1 month after last treatment (2 month from baseline)
measure: Incidence of adverse event
timeFrame: at every visit after treatment (baseline, day7, day14, day21)
measure: best spectacle corrected visual acuity (logMAR)
timeFrame: at every visit before treatment (baseline, day7, day14, day21)
measure: uncorrected visual acuity (logMAR)
timeFrame: at every visit before treatment (baseline, day7, day14, day21)
measure: Ocular Surface Index Score scored (OSDI score)
timeFrame: 2 month after last treatment (3 month from baseline)
measure: Lid margin thickening grade
timeFrame: 2 month after last treatment (3 month from baseline)
measure: Lid margin notching grade
timeFrame: 2 month after last treatment (3 month from baseline)
measure: Lid margin telangiectasia
timeFrame: 2 month after last treatment (3 month from baseline)
measure: meibomian gland cupping grade
timeFrame: 2 month after last treatment (3 month from baseline)
measure: Lid meibography grade (upper and lower lid)
timeFrame: 2 month after last treatment (3 month from baseline)
measure: meibum expressibility grade
timeFrame: 2 month after last treatment (3 month from baseline)
measure: meibum quality grade
timeFrame: 2 month after last treatment (3 month from baseline)
measure: Schirmer test (not use anaesthesia, mm)
timeFrame: 2 month after last treatment (3 month from baseline)
measure: Tear meniscus height
timeFrame: 2 month after last treatment (3 month from baseline)
measure: TFLLT (Tear film lipid layer thickness)
timeFrame: 2 month after last treatment (3 month from baseline)
measure: Bulbar conjunctiva hyperaemia (graded by Janvis score)
timeFrame: 2 month after last treatment (3 month from baseline)
measure: Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)
timeFrame: 2 month after last treatment (3 month from baseline)
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Lita Uthaithammarat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrari G, Colucci A, Barbariga M, Ruggeri A, Rama P. High Frequency Electrotherapy for the Treatment of Meibomian Gland Dysfunction. Cornea. 2019 Nov;38(11):1424-1429. doi: 10.1097/ICO.0000000000002063.