Clinical Efficacy and Molecular Dynamics of Quantum Molecular Resonance (QMR) Electrotherapy in Dry Eye Management
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- clinical efficacy
研究概览
简要总结
This project aims to investigate the clinical efficacy and molecular mechanisms of Quantum Molecular Resonance (QMR) electrotherapy in the management of dry eye disease (DED). DED is a multifactorial condition characterized by tear film instability, hyperosmolarity, inflammation, and neurosensory abnormalities, leading to discomfort and visual disturbances. The Rexon-Eye device, which utilizes QMR technology, has shown positive effects in alleviating dry eye symptoms. However, the exact mechanisms by which the stimulation of high-frequency electrical fields promotes improvement in DED remain unclear.
The research will be conducted as a longitudinal study involving 30 participants between the ages of 18 and 40 who meet the diagnostic criteria for DED. Participants will be randomly assigned to either a treatment group receiving QMR electrotherapy or a control group receiving a sham treatment, followed by a real treatment after second evaluation. Each participant in the treatment group will undergo a 20-minute weekly session for four weeks, with clinical evaluations and tear fluid collection occurring throughout the study.
Comprehensive assessments will be performed to evaluate tear film stability, lipid layer composition, ocular surface health and corneal sensitivity. Tear samples collected during the study will undergo molecular analysis using mass spectrometry to identify biochemical changes associated with QMR electrotherapy. Additionally, safety evaluations will be conducted at each visit to monitor potential adverse effects.
The study aims to determine whether QMR electrotherapy effectively improves clinical dry eye parameters while also uncovering the molecular changes in tear composition that may underlie its therapeutic effects. By exploring both clinical outcomes and biological mechanisms, this research will contribute valuable insights into the potential of QMR electrotherapy as an innovative treatment for dry eye disease.
详细描述
Study Purpose and Potential Benefits:
Recently, a high frequency electrotherapy device using Quantum Molecular Resonance (QMR) technique, the Rexon-Eye was being developed for dry eye treatment. During the treatment, a low-intensity, high-frequency (a spectrum of frequencies ranging from 4 MHz to 64 MHz) electrical stimulations are applied on the epidermis of closed eyelids up to the lid border by specially designed goggles. Previous data showed that it could effectively improve symptoms and clinical signs of DED by increasing the tear secretion and improving the meibomian gland function. Compared with conventional DED management options such as lubricant and warm compress, previous studies proposed that this treatment may allow a possible capability to induce reactivation of physiological lacrimal functions instead of a short-term symptom relief.
The aims of this project are to investigate the clinical efficacy of QMR electrotherapy and the associated changes in tear proteomics and lipidomics in the management of dry eye disease.
Participant Eligibility
- aged 18 to 40 years old
- with habitual or best corrected visual acuity better than or equal to 6/9
- diagnosed as dry eye disease according to OSDI score (13 or above) and at least one positive result from dry eye assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 to 40 years old
- •with habitual or best corrected visual acuity better than or equal to 6/9
- •diagnosed as dry eye disease according to OSDI score (13 or above) and at least one positive result from dry eye assessment.
排除标准
- •history of ocular inflammation, trauma or surgery within 6 months
- •long-term ocular medications
- •current dry eye treatment
- •uncontrolled, newly diagnosed systemic diseases
- •with modified long-term medications within 6 months that are known to affect tear profile
- •carrying active implantable devices (e.g., pacemakers and hearing aids)
研究组 & 干预措施
Treatment Arm
Following a comprehensive evaluation, the treatment group will undergo a 20-minute treatment once per week for four weeks.
干预措施: The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology (Device)
Control Arm
Following a comprehensive evaluation, the sham treatment group will firstly undergo a 20-minute sham treatment once per week for four weeks. Two additional comprehensive evaluations and tear fluid collections will be conducted one month and three months after the completion of the treatment period.
After the three-month post-treatment evaluation, the control group will receive four weekly treatments.
干预措施: The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology (Device)
结局指标
主要结局
clinical efficacy
时间窗: From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months
Ocular Surface Disease Index
次要结局
- The associated tear proteomics and lipidomics changes after Electrotherapy(From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months)
研究者
TSE Sung Hei Jimmy
Assistant Professor of Practice
The Hong Kong Polytechnic University