Efficacy of Quantum Molecular Resonance Combined With Intense Pulsed Light in Mixed Dry Eye
- Conditions
- Dry Eye
- Interventions
- Device: Quantum Molecular Resonance (QMR) TherapyDevice: Intense Pulsed Light (IPL) TherapyDrug: Tear Substitute Treatment (Supportive Therapy)
- Registration Number
- NCT06576245
- Lead Sponsor
- University of Seville
- Brief Summary
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.
- Detailed Description
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.
IPL (Intense Pulsed Light): This treatment uses light to heat the skin around the eyes, which helps improve the function of glands that produce the oily layer of tears, preventing tears from evaporating too quickly.
Study Design:
Participants: 25 patients with Mixed Dry Eye Treatment: Participants received 4 sessions of QMR and 3 sessions of IPL over 6 weeks. They were also given tear substitutes to use during the study.
Follow-up: Patients were evaluated at the beginning, and after 1 and 3 months to assess the improvement in their condition.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combination Treatment: Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL) Quantum Molecular Resonance (QMR) Therapy 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. Combination Treatment: Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL) Intense Pulsed Light (IPL) Therapy 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. Combination Treatment: Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL) Tear Substitute Treatment (Supportive Therapy) 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.
- Primary Outcome Measures
Name Time Method Improvement in Ocular Surface Disease Index (OSDI) Score 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.
- Secondary Outcome Measures
Name Time Method Change in Schirmer I Test (ST) Score Baseline, 1 month, 3 months The Schirmer I Test (ST) measures tear production. A strip of filter paper is placed under the lower eyelid, and the length of the wet portion of the strip is measured in millimeters after 5 minutes. The test is performed without anesthesia. The change in ST score from baseline to 1 month and 3 months after treatment will be used to assess improvements in tear production.
Change in Lipid Layer Thickness (LLT) Baseline, 1 month, 3 months Lipid Layer Thickness (LLT) of the tear film will be measured using the Lipiview II ocular surface interferometer. The LLT is expressed in nanometers (nm) and reflects the thickness of the lipid layer in the tear film. The change in LLT from baseline to 1 month and 3 months after treatment will be assessed to determine the effectiveness of the combination therapy in improving tear film stability.
Change in Non-Invasive Tear Film Break-Up Time (NIBUT) Baseline, 1 month, 3 months Non-Invasive Tear Film Break-Up Time (NIBUT) will be measured using the Keratograph 5M. NIBUT is the time taken for the tear film to break up after a blink, without the use of dyes or invasive techniques. It will be recorded in seconds. An increase in NIBUT indicates improved tear film stability. The change in NIBUT will be evaluated from baseline to 1 month and 3 months after treatment.
Trial Locations
- Locations (1)
Tedesco Eye Center
🇮🇹Girifalco, Catanzaro, Italy