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

December 7, 2021 updated by: Chulalongkorn University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University
        • Contact:
        • Principal Investigator:
          • Lita Uthaithammarat, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
non-invasive tear break-up time (NITBUT)
Time Frame: 1 month after last treatment (2 month from baseline)
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)
Time Frame: 2 month after last treatment (3 month from baseline)
Change from baseline NITBUT at 2 month after last treatment
2 month after last treatment (3 month from baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ocular Surface Index Score scored (OSDI score)
Time Frame: 1 month after last treatment (2 month from baseline)
Change from baseline OSDI score at 1 month after last treatment
1 month after last treatment (2 month from baseline)
Lid margin thickening grade
Time Frame: 1 month after last treatment (2 month from baseline)
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
Time Frame: 1 month after last treatment (2 month from baseline)
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
Time Frame: 1 month after last treatment (2 month from baseline)
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
Time Frame: 1 month after last treatment (2 month from baseline)
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)
Time Frame: 1 month after last treatment (2 month from baseline)
Change from baseline Lid meibography grade at 1 month after last treatment
1 month after last treatment (2 month from baseline)
meibum expressibility grade
Time Frame: 1 month after last treatment (2 month from baseline)
change from baseline meibum expressibility grade at 1 month after last treatment
1 month after last treatment (2 month from baseline)
meibum quality grade
Time Frame: 1 month after last treatment (2 month from baseline)
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)
Time Frame: 1 month after last treatment (2 month from baseline)
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)
Time Frame: 1 month after last treatment (2 month from baseline)
Change from baseline Tear cytokine level at 1 month after last treatment
1 month after last treatment (2 month from baseline)
Tear osmole
Time Frame: 1 month after last treatment (2 month from baseline)
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)
Time Frame: 1 month after last treatment (2 month from baseline)
Change from baseline schirmer test at 1 month after last treatment
1 month after last treatment (2 month from baseline)
Tear meniscus height
Time Frame: 1 month after last treatment (2 month from baseline)
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)
Time Frame: 1 month after last treatment (2 month from baseline)
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)
Time Frame: 1 month after last treatment (2 month from baseline)
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)
Time Frame: 1 month after last treatment (2 month from baseline)
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
Time Frame: at every visit after treatment (baseline, day7, day14, day21)
Incidence of adverse event
at every visit after treatment (baseline, day7, day14, day21)
best spectacle corrected visual acuity (logMAR)
Time Frame: at every visit before treatment (baseline, day7, day14, day21)
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)
Time Frame: at every visit before treatment (baseline, day7, day14, day21)
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)
Time Frame: 2 month after last treatment (3 month from baseline)
Change from baseline OSDI score at 2 month after last treatment
2 month after last treatment (3 month from baseline)
Lid margin thickening grade
Time Frame: 2 month after last treatment (3 month from baseline)
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
Time Frame: 2 month after last treatment (3 month from baseline)
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
Time Frame: 2 month after last treatment (3 month from baseline)
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
Time Frame: 2 month after last treatment (3 month from baseline)
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)
Time Frame: 2 month after last treatment (3 month from baseline)
Change from baseline Lid meibography grade at 2 month after last treatment
2 month after last treatment (3 month from baseline)
meibum expressibility grade
Time Frame: 2 month after last treatment (3 month from baseline)
change from baseline meibum expressibility grade at 2 month after last treatment
2 month after last treatment (3 month from baseline)
meibum quality grade
Time Frame: 2 month after last treatment (3 month from baseline)
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)
Time Frame: 2 month after last treatment (3 month from baseline)
Change from baseline schirmer test at 2 month after last treatment
2 month after last treatment (3 month from baseline)
Tear meniscus height
Time Frame: 2 month after last treatment (3 month from baseline)
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)
Time Frame: 2 month after last treatment (3 month from baseline)
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)
Time Frame: 2 month after last treatment (3 month from baseline)
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)
Time Frame: 2 month after last treatment (3 month from baseline)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chulalongkorn University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lita Uthaithammarat, MD, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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