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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Device: Rexon-eye

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lita Uthaithammarat, MD; Phone Number: 66867836002; Email: lita.t@chula.ac.th
• Study Contact Backup: Name: Ngamjit Kasetsuwan, MD; Email: ngamjitk@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Chulalongkorn University
    • Contact: Lita Uthaithammarat, MD; Phone Number: 66867836002; Email: lita.t@chula.ac.th
    • Principal Investigator: Lita Uthaithammarat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; This treatment is delivered by contact electrodes built in a mask, which is worn by the patient over closed eyes. The device setup is really easy and intuitive.	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; Other Names: Quantum Molecular Resonance device
Sham Comparator: Sham-intervention; The same device as treatment but the power of device will be set to ZERO power.	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; Other Names: Quantum Molecular Resonance device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Lid margin telangiectasia	Change from baseline Lid margin telangiectasia at 1 month after last treatment	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	1 month after last treatment (2 month from baseline)
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)
meibum expressibility grade	change from baseline meibum expressibility grade at 1 month after last treatment	1 month after last treatment (2 month from baseline)
meibum quality grade	Change from baseline meibum quality grade at 1 month after last treatment	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	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	1 month after last treatment (2 month from baseline)
Tear osmole	Change from baseline Tear osmole level at 1 month after last treatment	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	1 month after last treatment (2 month from baseline)
Tear meniscus height	Change from baseline Tear meniscus height at 1 month after last treatment	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	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	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	1 month after last treatment (2 month from baseline)
Incidence of adverse event	Incidence of adverse event	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	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	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	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	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	2 month after last treatment (3 month from baseline)
Lid margin telangiectasia	Change from baseline Lid margin telangiectasia at 2 month after last treatment	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	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	2 month after last treatment (3 month from baseline)
meibum expressibility grade	change from baseline meibum expressibility grade at 2 month after last treatment	2 month after last treatment (3 month from baseline)
meibum quality grade	Change from baseline meibum quality grade at 2 month after last treatment	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	2 month after last treatment (3 month from baseline)
Tear meniscus height	Change from baseline Tear meniscus height at 2 month after last treatment	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	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	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	2 month after last treatment (3 month from baseline)

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Lita Uthaithammarat, MD, Chulalongkorn University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: IRB 845/63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After submit to journal, I will send the raw data to the journal and published as supplementary file
• IPD Sharing Time Frame: After submitting to journal.
• IPD Sharing Access Criteria: I am happy to share all of my protocol and also my raw data to who which interested and plan to do the study about Recon-eye device. Moreover, If journal I have submitted want to publish all data and research protocol as supplementary or request me to upload in any data sharing website, I will follow their request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No