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

Chulalongkorn University

Status: Unknown

Conditions: Meibomian Gland Dysfunction

Treatments: Device: Rexon-eye

Study type: Interventional

Funder types: Other

Identifiers

NCT05165342

IRB 845/63

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Treatment

Experimental group

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.

Treatment:

Device: Rexon-eye

Sham-intervention

Sham Comparator group

Description:

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

Treatment:

Device: Rexon-eye