Quantum Molecular Resonance Effects on Patients With Dry Eye Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Disease Index (OSDI) Questionnaire
研究概览
简要总结
The Rexon Eye device (Resono Ophthalmic Inc, Trieste, Italy) is a new device based on QMR technology. Quantum Molecular Resonance (QMR) is a technique in which low-intensity, high-frequency electric currents are administered to a biological tissue through contact electrodes. The device applies stimulation to the epidermis of closed eyelids up to the lid margin by means of specially designed goggles. Previous studies have shown that it is relatively safe with high patient satisfaction. Preliminary studies have also shown it is effective for accelerating healing in chronic wounds and treating dry eye symptoms.
详细描述
In this study, the investigators aim to examine the efficacy of the Rexon eye device for the treatment of dry eye signs and symptoms in a randomized double-blind placebo-controlled fashion among a cohort of prospectively recruited patients with dry eye. The control group will receive a similar application of treatment with the device goggles disconnected from the device, effectively receiving no treatment. The treatment will be performed by research assistants following thorough instruction by the manufacturing company representatives and/or provided material. Participants will be actively questioned on any harms or side effects in every meeting.
Outcomes will be assessed based on clinical signs and by validated questionnaires on dry eye symptoms (OSDI).
Informed written consent will be obtained from all participants involved in the study prior to enrollment. The goal of the study is to evaluate the Rexon device as a possible additional treatment option for patients with dry eye or to establish it has no added benefit.
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
- Single (Participant)
盲法说明
The patient does not know wheater they are on treatment or placebo arm.
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
- •Patients above the age of 18 years
- •Patients who are willing and able to consent and adhere to the research plan
- •Patients diagnosed with dry eye or patients who are at risk for dry eye
排除标准
- •Active infection of the eyelid or periorbital area
- •Patients who are pregnant or lactating
- •Patients under the age of 18
- •Those scheduled for (<30 days) or immediately after (<30 days) ocular surgery (excluding cataract and eyelid surgery)
- •Patient who do not adhere to all four treatment sessions.
结局指标
主要结局
Change in Ocular Surface Disease Index (OSDI) Questionnaire
时间窗: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
A validated questionnaire that assess the symptoms of ocular irritation in dry eye disease. and how they affect functioning related to vision. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease
次要结局
- Change in Corneal Staining(At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))
- Change in Tear breakup time(At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))
- Change in Corrected visual acuity(At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))
- Change in Meibomian gland dysfunction Grading(At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))
- Change in Schirmer with anesthesia(At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))
研究者
Asaf Shemer
Physician in the Ophthalmology Department
Assaf-Harofeh Medical Center