Efficacy of Quantum Molecular Resonance Combined With Intense Pulsed Light in Mixed Dry Eye: A Prospective Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Improvement in Ocular Surface Disease Index (OSDI) Score
研究概览
简要总结
This study examines the effectiveness of combining Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL) treatments for Mixed Dry Eye, a condition where both tear production and tear quality are compromised. Twenty-five patients received both treatments over a period of six weeks, and their symptoms and tear quality were monitored for three months.
详细描述
Study Title: Efficacy of Quantum Molecular Resonance Combined with Intense Pulsed Light in Mixed Dry Eye: A Prospective Clinical Study
Purpose of the Study: This study aims to evaluate how well two treatments-Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL)-work when used together to treat Mixed Dry Eye (MDE). Mixed Dry Eye is a condition that affects both the quantity and quality of tears, leading to discomfort and vision problems. The goal is to see if combining these treatments can better relieve symptoms and improve tear production and stability.
What is Mixed Dry Eye? Dry Eye Disease is a common condition that can cause symptoms like burning, itching, and blurred vision. Mixed Dry Eye occurs when both the tear production is low, and the tears evaporate too quickly, leading to chronic discomfort.
What are QMR and IPL Treatments?
QMR (Quantum Molecular Resonance): This is a newer technology that uses low-intensity, high-frequency waves to stimulate the cells in the eye. It may help improve tear production and reduce inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 years or older
- •Diagnosed with Mixed Dry Eye (MDE)
- •Ocular Surface Disease Index (OSDI) score of 13 or higher
- •Non-Invasive Tear Film Break-Up Time (NIBUT) less than 10 seconds
- •Lipid Layer Thickness (LLT) less than 75 nm
- •Schirmer I Test (ST) without anesthesia less than 5 mm in 5 minutes
排除标准
- •Presence of skin conditions that prevent QMR or IPL treatments
- •Corneal disorders that affect diagnostic tests, including:
- •Active corneal infections
- •Corneal dystrophies
- •Active ocular allergy
- •Previous device-based dry eye treatments, such as:
- •Microblepharoexfoliation
- •Low-level light therapy
- •Vectored thermal pulsation
- •Inability to understand or comprehend the informed consent
- •Pregnant or lactating women
- •Contact lens wearers who do not discontinue lens use at least one week before baseline and follow-up exams
研究组 & 干预措施
Combination Treatment: Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL)
Participants in this arm will receive a combination treatment consisting of Quantum Molecular Resonance (QMR) therapy and Intense Pulsed Light (IPL) therapy. The treatment protocol includes 4 sessions of QMR and 3 sessions of IPL over a period of 6 weeks. QMR and IPL will be combined in certain weeks, with additional sessions of QMR and IPL performed separately in other weeks. The effectiveness of this combination therapy will be evaluated through various clinical endpoints, including improvements in tear film stability and dry eye symptoms over a 3-month follow-up period.
干预措施: Quantum Molecular Resonance (QMR) Therapy (Device)
Combination Treatment: Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL)
Participants in this arm will receive a combination treatment consisting of Quantum Molecular Resonance (QMR) therapy and Intense Pulsed Light (IPL) therapy. The treatment protocol includes 4 sessions of QMR and 3 sessions of IPL over a period of 6 weeks. QMR and IPL will be combined in certain weeks, with additional sessions of QMR and IPL performed separately in other weeks. The effectiveness of this combination therapy will be evaluated through various clinical endpoints, including improvements in tear film stability and dry eye symptoms over a 3-month follow-up period.
干预措施: Intense Pulsed Light (IPL) Therapy (Device)
Combination Treatment: Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL)
Participants in this arm will receive a combination treatment consisting of Quantum Molecular Resonance (QMR) therapy and Intense Pulsed Light (IPL) therapy. The treatment protocol includes 4 sessions of QMR and 3 sessions of IPL over a period of 6 weeks. QMR and IPL will be combined in certain weeks, with additional sessions of QMR and IPL performed separately in other weeks. The effectiveness of this combination therapy will be evaluated through various clinical endpoints, including improvements in tear film stability and dry eye symptoms over a 3-month follow-up period.
干预措施: Tear Substitute Treatment (Supportive Therapy) (Drug)
结局指标
主要结局
Improvement in Ocular Surface Disease Index (OSDI) Score
时间窗: Baseline, 1 month, 3 months
The Ocular Surface Disease Index (OSDI) is a patient-reported questionnaire used to assess the severity of dry eye symptoms. It includes 12 items, with scores ranging from 0 (no symptoms) to 100 (severe symptoms). The change in OSDI score from baseline to 1 month and 3 months after treatment will be measured. A significant reduction in OSDI score indicates an improvement in dry eye symptoms.
次要结局
- Change in Schirmer I Test (ST) Score(Baseline, 1 month, 3 months)
- Change in Lipid Layer Thickness (LLT)(Baseline, 1 month, 3 months)
- Change in Non-Invasive Tear Film Break-Up Time (NIBUT)(Baseline, 1 month, 3 months)
研究者
José-María Sánchez-González
Head of Vision Science Research Group
University of Seville