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

Sponsor
Chulalongkorn University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05165342
Collaborator
(none)
80
1
2
4
20.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Rexon-eye
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness and Safety of High Frequency Electrotherapy in Patients With Meibomian Gland Dysfunction : Randomized Controlled Trial
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. non-invasive tear break-up time (NITBUT) [1 month after last treatment (2 month from baseline)]

      Change from baseline NITBUT at 1 month after last treatment

    2. non-invasive tear break-up time (NITBUT) [2 month after last treatment (3 month from baseline)]

      Change from baseline NITBUT at 2 month after last treatment

    Secondary Outcome Measures

    1. Ocular Surface Index Score scored (OSDI score) [1 month after last treatment (2 month from baseline)]

      Change from baseline OSDI score at 1 month after last treatment

    2. Lid margin thickening grade [1 month after last treatment (2 month from baseline)]

      Change from baseline Lid margin thickening grade at 1 month after last treatment

    3. Lid margin notching grade [1 month after last treatment (2 month from baseline)]

      Change from baseline Lid margin notching grade at 1 month after last treatment

    4. Lid margin telangiectasia [1 month after last treatment (2 month from baseline)]

      Change from baseline Lid margin telangiectasia at 1 month after last treatment

    5. meibomian gland cupping grade [1 month after last treatment (2 month from baseline)]

      Change from baseline meibomian gland cupping grade at 1 month after last treatment

    6. Lid meibography grade (upper and lower lid) [1 month after last treatment (2 month from baseline)]

      Change from baseline Lid meibography grade at 1 month after last treatment

    7. meibum expressibility grade [1 month after last treatment (2 month from baseline)]

      change from baseline meibum expressibility grade at 1 month after last treatment

    8. meibum quality grade [1 month after last treatment (2 month from baseline)]

      Change from baseline meibum quality grade at 1 month after last treatment

    9. Amount of bacteria culture from lid margin and meibum (colony forming unit) [1 month after last treatment (2 month from baseline)]

      Change from baseline meibum quality grade at 1 month after last treatment

    10. Tear cytokine level (Interleukin-6, Interferon-gamma, Interleukin-1RA) [1 month after last treatment (2 month from baseline)]

      Change from baseline Tear cytokine level at 1 month after last treatment

    11. Tear osmole [1 month after last treatment (2 month from baseline)]

      Change from baseline Tear osmole level at 1 month after last treatment

    12. Schirmer test (not use anaesthesia, mm) [1 month after last treatment (2 month from baseline)]

      Change from baseline schirmer test at 1 month after last treatment

    13. Tear meniscus height [1 month after last treatment (2 month from baseline)]

      Change from baseline Tear meniscus height at 1 month after last treatment

    14. TFLLT (Tear film lipid layer thickness) [1 month after last treatment (2 month from baseline)]

      Change from baseline TFLLT at 1 month after last treatment

    15. Bulbar conjunctiva hyperaemia (graded by Janvis score) [1 month after last treatment (2 month from baseline)]

      Change from baseline Bulbar conjunctiva hyperaemia at 1 month after last treatment

    16. Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain) [1 month after last treatment (2 month from baseline)]

      Change from baseline corneal and conjunctival stain at 1 month after last treatment

    17. Incidence of adverse event [at every visit after treatment (baseline, day7, day14, day21)]

      Incidence of adverse event

    18. best spectacle corrected visual acuity (logMAR) [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

    19. uncorrected visual acuity (logMAR) [at every visit before treatment (baseline, day7, day14, day21)]

      Any change from baseline uncorrected visual acuity (logMAR) at day7, day14, and day 21

    20. Ocular Surface Index Score scored (OSDI score) [2 month after last treatment (3 month from baseline)]

      Change from baseline OSDI score at 2 month after last treatment

    21. Lid margin thickening grade [2 month after last treatment (3 month from baseline)]

      Change from baseline Lid margin thickening grade at 2 month after last treatment

    22. Lid margin notching grade [2 month after last treatment (3 month from baseline)]

      Change from baseline Lid margin notching grade at 2 month after last treatment

    23. Lid margin telangiectasia [2 month after last treatment (3 month from baseline)]

      Change from baseline Lid margin telangiectasia at 2 month after last treatment

    24. meibomian gland cupping grade [2 month after last treatment (3 month from baseline)]

      Change from baseline meibomian gland cupping grade at 2 month after last treatment

    25. Lid meibography grade (upper and lower lid) [2 month after last treatment (3 month from baseline)]

      Change from baseline Lid meibography grade at 2 month after last treatment

    26. meibum expressibility grade [2 month after last treatment (3 month from baseline)]

      change from baseline meibum expressibility grade at 2 month after last treatment

    27. meibum quality grade [2 month after last treatment (3 month from baseline)]

      Change from baseline meibum quality grade at 2 month after last treatment

    28. Schirmer test (not use anaesthesia, mm) [2 month after last treatment (3 month from baseline)]

      Change from baseline schirmer test at 2 month after last treatment

    29. Tear meniscus height [2 month after last treatment (3 month from baseline)]

      Change from baseline Tear meniscus height at 2 month after last treatment

    30. TFLLT (Tear film lipid layer thickness) [2 month after last treatment (3 month from baseline)]

      Change from baseline TFLLT at 2 month after last treatment

    31. Bulbar conjunctiva hyperaemia (graded by Janvis score) [2 month after last treatment (3 month from baseline)]

      Change from baseline Bulbar conjunctiva hyperaemia at 2 month after last treatment

    32. Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain) [2 month after last treatment (3 month from baseline)]

      Change from baseline corneal and conjunctival stain at 2 month after last treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chulalongkorn University Bangkok Thailand 10330

    Sponsors and Collaborators

    • Chulalongkorn University

    Investigators

    • Principal Investigator: Lita Uthaithammarat, MD, Chulalongkorn University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chulalongkorn University
    ClinicalTrials.gov Identifier:
    NCT05165342
    Other Study ID Numbers:
    • IRB 845/63
    First Posted:
    Dec 21, 2021
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 21, 2021