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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Sham-intervention | Sham Comparator | The same device as treatment but the power of device will be set to ZERO power. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rexon-eye | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| non-invasive tear break-up time (NITBUT) | 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) | Change from baseline NITBUT at 2 month after last treatment | 2 month after last treatment (3 month from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Index Score scored (OSDI score) | Change from baseline OSDI score at 1 month after last treatment | 1 month after last treatment (2 month from baseline) |
| Lid margin thickening grade |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lita Uthaithammarat, MD | Contact | 66867836002 | lita.t@chula.ac.th | |
| Ngamjit Kasetsuwan, MD | Contact | ngamjitk@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lita Uthaithammarat, MD | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University | Recruiting | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31356415 | Result | 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. |
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After submit to journal, I will send the raw data to the journal and published as supplementary file
After submitting to journal.
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.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 9, 2022 | |
| Reset | Aug 25, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 9, 2022 | Aug 25, 2023 |
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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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 | 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 | 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 | 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) | Change from baseline Lid meibography grade at 1 month after last treatment | 1 month after last treatment (2 month from baseline) |
| meibum expressibility grade | change from baseline meibum expressibility grade at 1 month after last treatment | 1 month after last treatment (2 month from baseline) |
| meibum quality grade | 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) | 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) | Change from baseline Tear cytokine level at 1 month after last treatment | 1 month after last treatment (2 month from baseline) |
| Tear osmole | 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) | Change from baseline schirmer test at 1 month after last treatment | 1 month after last treatment (2 month from baseline) |
| Tear meniscus height | 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) | 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) | 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) | 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 | Incidence of adverse event | at every visit after treatment (baseline, day7, day14, day21) |
| best spectacle corrected visual acuity (logMAR) | 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) | 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) | Change from baseline OSDI score at 2 month after last treatment | 2 month after last treatment (3 month from baseline) |
| Lid margin thickening grade | 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 | 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 | 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 | 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) | Change from baseline Lid meibography grade at 2 month after last treatment | 2 month after last treatment (3 month from baseline) |
| meibum expressibility grade | change from baseline meibum expressibility grade at 2 month after last treatment | 2 month after last treatment (3 month from baseline) |
| meibum quality grade | 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) | Change from baseline schirmer test at 2 month after last treatment | 2 month after last treatment (3 month from baseline) |
| Tear meniscus height | 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) | 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) | 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) | Change from baseline corneal and conjunctival stain at 2 month after last treatment | 2 month after last treatment (3 month from baseline) |