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

Primary Purpose

Meibomian Gland Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Rexon-eye
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chulalongkorn UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Sham-intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

non-invasive tear break-up time (NITBUT)
Change from baseline NITBUT at 1 month after last treatment
non-invasive tear break-up time (NITBUT)
Change from baseline NITBUT at 2 month after last treatment

Secondary Outcome Measures

Ocular Surface Index Score scored (OSDI score)
Change from baseline OSDI score at 1 month after last treatment
Lid margin thickening grade
Change from baseline Lid margin thickening grade at 1 month after last treatment
Lid margin notching grade
Change from baseline Lid margin notching grade at 1 month after last treatment
Lid margin telangiectasia
Change from baseline Lid margin telangiectasia at 1 month after last treatment
meibomian gland cupping grade
Change from baseline meibomian gland cupping grade at 1 month after last treatment
Lid meibography grade (upper and lower lid)
Change from baseline Lid meibography grade at 1 month after last treatment
meibum expressibility grade
change from baseline meibum expressibility grade at 1 month after last treatment
meibum quality grade
Change from baseline meibum quality grade at 1 month after last treatment
Amount of bacteria culture from lid margin and meibum (colony forming unit)
Change from baseline meibum quality grade at 1 month after last treatment
Tear cytokine level (Interleukin-6, Interferon-gamma, Interleukin-1RA)
Change from baseline Tear cytokine level at 1 month after last treatment
Tear osmole
Change from baseline Tear osmole level at 1 month after last treatment
Schirmer test (not use anaesthesia, mm)
Change from baseline schirmer test at 1 month after last treatment
Tear meniscus height
Change from baseline Tear meniscus height at 1 month after last treatment
TFLLT (Tear film lipid layer thickness)
Change from baseline TFLLT at 1 month after last treatment
Bulbar conjunctiva hyperaemia (graded by Janvis score)
Change from baseline Bulbar conjunctiva hyperaemia at 1 month after last treatment
Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)
Change from baseline corneal and conjunctival stain at 1 month after last treatment
Incidence of adverse event
Incidence of adverse event
best spectacle corrected visual acuity (logMAR)
Any change from baseline best spectacle corrected visual acuity (logMAR) at day7, day14, and day 21
uncorrected visual acuity (logMAR)
Any change from baseline uncorrected visual acuity (logMAR) at day7, day14, and day 21
Ocular Surface Index Score scored (OSDI score)
Change from baseline OSDI score at 2 month after last treatment
Lid margin thickening grade
Change from baseline Lid margin thickening grade at 2 month after last treatment
Lid margin notching grade
Change from baseline Lid margin notching grade at 2 month after last treatment
Lid margin telangiectasia
Change from baseline Lid margin telangiectasia at 2 month after last treatment
meibomian gland cupping grade
Change from baseline meibomian gland cupping grade at 2 month after last treatment
Lid meibography grade (upper and lower lid)
Change from baseline Lid meibography grade at 2 month after last treatment
meibum expressibility grade
change from baseline meibum expressibility grade at 2 month after last treatment
meibum quality grade
Change from baseline meibum quality grade at 2 month after last treatment
Schirmer test (not use anaesthesia, mm)
Change from baseline schirmer test at 2 month after last treatment
Tear meniscus height
Change from baseline Tear meniscus height at 2 month after last treatment
TFLLT (Tear film lipid layer thickness)
Change from baseline TFLLT at 2 month after last treatment
Bulbar conjunctiva hyperaemia (graded by Janvis score)
Change from baseline Bulbar conjunctiva hyperaemia at 2 month after last treatment
Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)
Change from baseline corneal and conjunctival stain at 2 month after last treatment

Full Information

First Posted
November 17, 2021
Last Updated
December 7, 2021
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT05165342
Brief Title
Effectiveness and Safety of High Frequency Electrotherapy in Patients With Meibomian Gland Dysfunction
Official Title
Effectiveness and Safety of High Frequency Electrotherapy in Patients With Meibomian Gland Dysfunction : Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham-intervention
Arm Type
Sham Comparator
Arm Description
The same device as treatment but the power of device will be set to ZERO power.
Intervention Type
Device
Intervention Name(s)
Rexon-eye
Other Intervention Name(s)
Quantum Molecular Resonance device
Intervention Description
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
Primary Outcome Measure Information:
Title
non-invasive tear break-up time (NITBUT)
Description
Change from baseline NITBUT at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
non-invasive tear break-up time (NITBUT)
Description
Change from baseline NITBUT at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Secondary Outcome Measure Information:
Title
Ocular Surface Index Score scored (OSDI score)
Description
Change from baseline OSDI score at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Lid margin thickening grade
Description
Change from baseline Lid margin thickening grade at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Lid margin notching grade
Description
Change from baseline Lid margin notching grade at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Lid margin telangiectasia
Description
Change from baseline Lid margin telangiectasia at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
meibomian gland cupping grade
Description
Change from baseline meibomian gland cupping grade at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Lid meibography grade (upper and lower lid)
Description
Change from baseline Lid meibography grade at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
meibum expressibility grade
Description
change from baseline meibum expressibility grade at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
meibum quality grade
Description
Change from baseline meibum quality grade at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Amount of bacteria culture from lid margin and meibum (colony forming unit)
Description
Change from baseline meibum quality grade at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Tear cytokine level (Interleukin-6, Interferon-gamma, Interleukin-1RA)
Description
Change from baseline Tear cytokine level at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Tear osmole
Description
Change from baseline Tear osmole level at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Schirmer test (not use anaesthesia, mm)
Description
Change from baseline schirmer test at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Tear meniscus height
Description
Change from baseline Tear meniscus height at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
TFLLT (Tear film lipid layer thickness)
Description
Change from baseline TFLLT at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Bulbar conjunctiva hyperaemia (graded by Janvis score)
Description
Change from baseline Bulbar conjunctiva hyperaemia at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)
Description
Change from baseline corneal and conjunctival stain at 1 month after last treatment
Time Frame
1 month after last treatment (2 month from baseline)
Title
Incidence of adverse event
Description
Incidence of adverse event
Time Frame
at every visit after treatment (baseline, day7, day14, day21)
Title
best spectacle corrected visual acuity (logMAR)
Description
Any change from baseline best spectacle corrected visual acuity (logMAR) at day7, day14, and day 21
Time Frame
at every visit before treatment (baseline, day7, day14, day21)
Title
uncorrected visual acuity (logMAR)
Description
Any change from baseline uncorrected visual acuity (logMAR) at day7, day14, and day 21
Time Frame
at every visit before treatment (baseline, day7, day14, day21)
Title
Ocular Surface Index Score scored (OSDI score)
Description
Change from baseline OSDI score at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
Lid margin thickening grade
Description
Change from baseline Lid margin thickening grade at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
Lid margin notching grade
Description
Change from baseline Lid margin notching grade at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
Lid margin telangiectasia
Description
Change from baseline Lid margin telangiectasia at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
meibomian gland cupping grade
Description
Change from baseline meibomian gland cupping grade at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
Lid meibography grade (upper and lower lid)
Description
Change from baseline Lid meibography grade at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
meibum expressibility grade
Description
change from baseline meibum expressibility grade at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
meibum quality grade
Description
Change from baseline meibum quality grade at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
Schirmer test (not use anaesthesia, mm)
Description
Change from baseline schirmer test at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
Tear meniscus height
Description
Change from baseline Tear meniscus height at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
TFLLT (Tear film lipid layer thickness)
Description
Change from baseline TFLLT at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
Bulbar conjunctiva hyperaemia (graded by Janvis score)
Description
Change from baseline Bulbar conjunctiva hyperaemia at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)
Title
Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)
Description
Change from baseline corneal and conjunctival stain at 2 month after last treatment
Time Frame
2 month after last treatment (3 month from baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lita Uthaithammarat, MD
Phone
66867836002
Email
lita.t@chula.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Ngamjit Kasetsuwan, MD
Email
ngamjitk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lita Uthaithammarat, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lita Uthaithammarat, MD
Phone
66867836002
Email
lita.t@chula.ac.th
First Name & Middle Initial & Last Name & Degree
Lita Uthaithammarat, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
31356415
Citation
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.
Results Reference
result

Learn more about this trial

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

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