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

NCT05165342 | Unknown

• 1 other identifier: IRB 845/63
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (32)

• Ocular Surface Index Score scored (OSDI score)

  1 month after last treatment (2 month from baseline)

• Lid margin thickening grade

  1 month after last treatment (2 month from baseline)

• Lid margin notching grade

  1 month after last treatment (2 month from baseline)

• Lid margin telangiectasia

  1 month after last treatment (2 month from baseline)

• meibomian gland cupping grade

  1 month after last treatment (2 month from baseline)

Study Arms (2)

Treatment

EXPERIMENTAL

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

Sham-intervention

SHAM COMPARATOR

The same device as treatment but the power of device will be set to ZERO power.

Device: Rexon-eye

Interventions

Rexon-eye DEVICE

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

Also known as: Quantum Molecular Resonance device

Sham-intervention; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Declared legally blind in one eye
• Lipiflow treatment, or any equivalent treatments, within the past 12 months

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

Related 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.

  PMID: 31356415 RESULT

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Lita Uthaithammarat, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lita Uthaithammarat, MD

CONTACT

66867836002; lita.t@chula.ac.th

Ngamjit Kasetsuwan, MD

CONTACT

ngamjitk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 21, 2021
• Study Start: December 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After submitting to journal.
• 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.

Locations

TH (1)