Meibomian Gland Dysfunction
Conditions
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.
Interventions
DEVICERexon-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
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Lid margin telangiectasia | 1 month after last treatment (2 month from baseline) | Change from baseline Lid margin telangiectasia at 1 month after last treatment |
| 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 |
| 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 |
| meibum expressibility grade | 1 month after last treatment (2 month from baseline) | change from baseline meibum expressibility grade at 1 month after last treatment |
| meibum quality grade | 1 month after last treatment (2 month from baseline) | Change from baseline meibum quality grade at 1 month after last treatment |
| 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 |
| 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 |
| 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 |
| Tear meniscus height | 1 month after last treatment (2 month from baseline) | Change from baseline Tear meniscus height at 1 month after last treatment |
| 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 |
| 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 |
| 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 |
| Incidence of adverse event | at every visit after treatment (baseline, day7, day14, day21) | Incidence of adverse event |
| 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 |
| 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 |
| Tear osmole | 1 month after last treatment (2 month from baseline) | Change from baseline Tear osmole level at 1 month after last treatment |
Countries
Thailand
Contacts
Primary ContactLita Uthaithammarat, MD
Backup ContactNgamjit Kasetsuwan, MD
Outcome results
None listed