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Meibomian Gland DysfunctionNCT05165342

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

A study testing Rexon-eye in people with Meibomian Gland Dysfunction, run by Chulalongkorn University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meibomian Gland Dysfunction
What is being tested?
Rexon-eye
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteThailand
Study dates
Dec 2021to Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Lita Uthaithammarat, MD contact

66867836002

lita.t@chula.ac.th

Ngamjit Kasetsuwan, MD contact

ngamjitk@gmail.com

Thailand1 site, 1 recruiting

  • Chulalongkorn University

    Bangkok, 10330

    Lita Uthaithammarat, MD, 66867836002, lita.t@chula.ac.th

    Lita Uthaithammarat, MD

    Recruiting

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
Rexon-eye
Medical subject headings
Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rexon-eyeDevice

    Also called Quantum Molecular Resonance 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

Study groups in NCT05165342
Study groupRoleWhat they receive
TreatmentExperimentalThis 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.
Receives: Device: Rexon-eye
Sham-interventionSham comparatorThe same device as treatment but the power of device will be set to ZERO power.
Receives: Device: Rexon-eye

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. non-invasive tear break-up time (NITBUT)

    Change from baseline NITBUT at 1 month after last treatment

    Measured: 1 month after last treatment (2 month from baseline)

  2. non-invasive tear break-up time (NITBUT)

    Change from baseline NITBUT at 2 month after last treatment

    Measured: 2 month after last treatment (3 month from baseline)

Secondary outcomes (32)

  1. Ocular Surface Index Score scored (OSDI score)

    Change from baseline OSDI score at 1 month after last treatment

    Measured: 1 month after last treatment (2 month from baseline)

  2. Lid margin thickening grade

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

    Measured: 1 month after last treatment (2 month from baseline)

  3. Lid margin notching grade

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

    Measured: 1 month after last treatment (2 month from baseline)

  4. Lid margin telangiectasia

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

    Measured: 1 month after last treatment (2 month from baseline)

  5. meibomian gland cupping grade

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

    Measured: 1 month after last treatment (2 month from baseline)

  6. Lid meibography grade (upper and lower lid)

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

    Measured: 1 month after last treatment (2 month from baseline)

  7. meibum expressibility grade

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

    Measured: 1 month after last treatment (2 month from baseline)

  8. meibum quality grade

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

    Measured: 1 month after last treatment (2 month from baseline)

  9. Amount of bacteria culture from lid margin and meibum (colony forming unit)

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

    Measured: 1 month after last treatment (2 month from baseline)

  10. Tear cytokine level (Interleukin-6, Interferon-gamma, Interleukin-1RA)

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

    Measured: 1 month after last treatment (2 month from baseline)

  11. Tear osmole

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

    Measured: 1 month after last treatment (2 month from baseline)

  12. Schirmer test (not use anaesthesia, mm)

    Change from baseline schirmer test at 1 month after last treatment

    Measured: 1 month after last treatment (2 month from baseline)

  13. Tear meniscus height

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

    Measured: 1 month after last treatment (2 month from baseline)

  14. TFLLT (Tear film lipid layer thickness)

    Change from baseline TFLLT at 1 month after last treatment

    Measured: 1 month after last treatment (2 month from baseline)

  15. Bulbar conjunctiva hyperaemia (graded by Janvis score)

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

    Measured: 1 month after last treatment (2 month from baseline)

  16. Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)

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

    Measured: 1 month after last treatment (2 month from baseline)

  17. Incidence of adverse event

    Incidence of adverse event

    Measured: at every visit after treatment (baseline, day7, day14, day21)

  18. best spectacle corrected visual acuity (logMAR)

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

    Measured: at every visit before treatment (baseline, day7, day14, day21)

  19. uncorrected visual acuity (logMAR)

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

    Measured: at every visit before treatment (baseline, day7, day14, day21)

  20. Ocular Surface Index Score scored (OSDI score)

    Change from baseline OSDI score at 2 month after last treatment

    Measured: 2 month after last treatment (3 month from baseline)

  21. Lid margin thickening grade

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

    Measured: 2 month after last treatment (3 month from baseline)

  22. Lid margin notching grade

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

    Measured: 2 month after last treatment (3 month from baseline)

  23. Lid margin telangiectasia

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

    Measured: 2 month after last treatment (3 month from baseline)

  24. meibomian gland cupping grade

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

    Measured: 2 month after last treatment (3 month from baseline)

  25. Lid meibography grade (upper and lower lid)

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

    Measured: 2 month after last treatment (3 month from baseline)

  26. meibum expressibility grade

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

    Measured: 2 month after last treatment (3 month from baseline)

  27. meibum quality grade

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

    Measured: 2 month after last treatment (3 month from baseline)

  28. Schirmer test (not use anaesthesia, mm)

    Change from baseline schirmer test at 2 month after last treatment

    Measured: 2 month after last treatment (3 month from baseline)

  29. Tear meniscus height

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

    Measured: 2 month after last treatment (3 month from baseline)

  30. TFLLT (Tear film lipid layer thickness)

    Change from baseline TFLLT at 2 month after last treatment

    Measured: 2 month after last treatment (3 month from baseline)

  31. Bulbar conjunctiva hyperaemia (graded by Janvis score)

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

    Measured: 2 month after last treatment (3 month from baseline)

  32. Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)

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

    Measured: 2 month after last treatment (3 month from baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2021
  2. Study startDec 2021 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionApr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05165342
Sponsor's protocol ID
IRB 845/63
Status last verified
Nov 2021
First submitted
17 Nov 2021
Last updated
21 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After submit to journal, I will send the raw data to the journal and published as supplementary file

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.

    PubMed 31356415

Questions about this trial

What is this clinical trial studying?

A study testing Rexon-eye in people with Meibomian Gland Dysfunction, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lita Uthaithammarat, MD (66867836002, lita.t@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

non-invasive tear break-up time (NITBUT) (time frame: 1 month after last treatment (2 month from baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05165342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.

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