Effectiveness and Safety of High Frequency Electrotherapy in Patients With Meibomian Gland Dysfunction : Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- non-invasive tear break-up time (NITBUT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
non-invasive tear break-up time (NITBUT)
时间窗: 2 month after last treatment (3 month from baseline)
Change from baseline NITBUT at 2 month after last treatment
次要结局
- Ocular Surface Index Score scored (OSDI score)(2 month after last treatment (3 month from baseline))
- Lid meibography grade (upper and lower lid)(2 month after last treatment (3 month from baseline))
- meibum expressibility grade(2 month after last treatment (3 month from baseline))
- Tear osmole(1 month after last treatment (2 month from baseline))
- Bulbar conjunctiva hyperaemia (graded by Janvis score)(2 month after last treatment (3 month from baseline))
- Tear cytokine level (Interleukin-6, Interferon-gamma, Interleukin-1RA)(1 month after last treatment (2 month from baseline))
- Lid margin thickening grade(2 month after last treatment (3 month from baseline))
- Lid margin notching grade(2 month after last treatment (3 month from baseline))
- meibomian gland cupping grade(2 month after last treatment (3 month from baseline))
- meibum quality grade(2 month after last treatment (3 month from baseline))
- Tear meniscus height(2 month after last treatment (3 month from baseline))
- TFLLT (Tear film lipid layer thickness)(2 month after last treatment (3 month from baseline))
- Corneal and conjunctiva staining score (Use fluorescent and lissamine green stain)(2 month after last treatment (3 month from baseline))
- Incidence of adverse event(at every visit after treatment (baseline, day7, day14, day21))
- Lid margin telangiectasia(2 month after last treatment (3 month from baseline))
- best spectacle corrected visual acuity (logMAR)(at every visit before treatment (baseline, day7, day14, day21))
- uncorrected visual acuity (logMAR)(at every visit before treatment (baseline, day7, day14, day21))
- Amount of bacteria culture from lid margin and meibum (colony forming unit)(1 month after last treatment (2 month from baseline))
- Schirmer test (not use anaesthesia, mm)(2 month after last treatment (3 month from baseline))