Efficacy of Quantum Molecular Resonance Combined With Intense Pulsed Light in Mixed Dry Eye

University of Seville

Status: Completed

Conditions: Dry Eye

Treatments: Device: Intense Pulsed Light (IPL) Therapy; Device: Quantum Molecular Resonance (QMR) Therapy; Drug: Tear Substitute Treatment (Supportive Therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT06576245

USeville_2024_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Combination Treatment: Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL)

Experimental group

Description:

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.

Treatment:

Drug: Tear Substitute Treatment (Supportive Therapy)

Device: Quantum Molecular Resonance (QMR) Therapy

Device: Intense Pulsed Light (IPL) Therapy