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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165342
• Other study ID #: IRB 845/63
• Status: Recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: April 2022

Study information

• Verified date: November 2021
• Source: Chulalongkorn University
• Contact: Lita Uthaithammarat, MD
• Phone: 66867836002
• Email: lita.t[@]chula.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Device:
• Rexon-eye
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

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non-invasive tear break-up time (NITBUT)	Change from baseline NITBUT at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Primary	non-invasive tear break-up time (NITBUT)	Change from baseline NITBUT at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	Ocular Surface Index Score scored (OSDI score)	Change from baseline OSDI score at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Lid margin thickening grade	Change from baseline Lid margin thickening grade at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Lid margin notching grade	Change from baseline Lid margin notching grade at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Lid margin telangiectasia	Change from baseline Lid margin telangiectasia at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	meibomian gland cupping grade	Change from baseline meibomian gland cupping grade at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Lid meibography grade (upper and lower lid)	Change from baseline Lid meibography grade at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	meibum expressibility grade	change from baseline meibum expressibility grade at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	meibum quality grade	Change from baseline meibum quality grade at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Amount of bacteria culture from lid margin and meibum (colony forming unit)	Change from baseline meibum quality grade at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Tear cytokine level (Interleukin-6, Interferon-gamma, Interleukin-1RA)	Change from baseline Tear cytokine level at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Tear osmole	Change from baseline Tear osmole level at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Schirmer test (not use anaesthesia, mm)	Change from baseline schirmer test at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Tear meniscus height	Change from baseline Tear meniscus height at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	TFLLT (Tear film lipid layer thickness)	Change from baseline TFLLT at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Bulbar conjunctiva hyperaemia (graded by Janvis score)	Change from baseline Bulbar conjunctiva hyperaemia at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)	Change from baseline corneal and conjunctival stain at 1 month after last treatment	1 month after last treatment (2 month from baseline)
Secondary	Incidence of adverse event	Incidence of adverse event	at every visit after treatment (baseline, day7, day14, day21)
Secondary	best spectacle corrected visual acuity (logMAR)	Any change from baseline best spectacle corrected visual acuity (logMAR) at day7, day14, and day 21	at every visit before treatment (baseline, day7, day14, day21)
Secondary	uncorrected visual acuity (logMAR)	Any change from baseline uncorrected visual acuity (logMAR) at day7, day14, and day 21	at every visit before treatment (baseline, day7, day14, day21)
Secondary	Ocular Surface Index Score scored (OSDI score)	Change from baseline OSDI score at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	Lid margin thickening grade	Change from baseline Lid margin thickening grade at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	Lid margin notching grade	Change from baseline Lid margin notching grade at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	Lid margin telangiectasia	Change from baseline Lid margin telangiectasia at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	meibomian gland cupping grade	Change from baseline meibomian gland cupping grade at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	Lid meibography grade (upper and lower lid)	Change from baseline Lid meibography grade at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	meibum expressibility grade	change from baseline meibum expressibility grade at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	meibum quality grade	Change from baseline meibum quality grade at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	Schirmer test (not use anaesthesia, mm)	Change from baseline schirmer test at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	Tear meniscus height	Change from baseline Tear meniscus height at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	TFLLT (Tear film lipid layer thickness)	Change from baseline TFLLT at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	Bulbar conjunctiva hyperaemia (graded by Janvis score)	Change from baseline Bulbar conjunctiva hyperaemia at 2 month after last treatment	2 month after last treatment (3 month from baseline)
Secondary	Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)	Change from baseline corneal and conjunctival stain at 2 month after last treatment	2 month after last treatment (3 month from baseline)