NCT06576245

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

Efficacy of Quantum Molecular Resonance Combined With Intense Pulsed Light in Mixed Dry Eye: A Prospective Clinical Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	Quantum Molecular Resonance (QMR) Therapy	Quantum Molecular Resonance (QMR) therapy will be administered using the RexonEye® device (Resono Ophthalmic, Trieste, Italy). The device delivers low-intensity, high-frequency electrical waves ranging from 4-64 MHz through specialized contact electrodes. Participants will receive 4 QMR treatment sessions over 6 weeks. Each session lasts for 20 minutes, with a 30-second alternation between the eyes. The goal of QMR therapy is to stimulate cellular regeneration and improve tear production by targeting the lacrimal gland.
DEVICE	Intense Pulsed Light (IPL) Therapy	Intense Pulsed Light (IPL) therapy will be performed using the OptiLIGHT® device (Lumenis Be Ltd., Yokneam, Israel). IPL treatment involves the application of high-intensity, non-coherent, polychromatic light within the 500 to 1200 nm wavelength spectrum. Participants will receive 3 IPL sessions over 6 weeks, with sessions targeting the periocular area and upper eyelids to improve meibomian gland function. Each session includes the application of 50 light pulses to the periocular area and upper eyelids using specified parameters (e.g., fluence 14 J/cm² for the periocular area, fluence 11 J/cm² for the upper eyelids).
DRUG	Tear Substitute Treatment (Supportive Therapy)	All participants will also receive supportive therapy with tear substitutes throughout the study period. This includes: Idroflog® (0.2% Hyaluronic Acid with 0.001% Hydrocortisone): Applied 3 times per day. VisuXL gel® (Cross-linked Carboxymethyl Cellulose with Coenzyme Q10): Applied once a day. Artelac® Nighttime Gel (0.24% Sodium Hyaluronate with Carbomer): Applied before sleeping. These tear substitutes are intended to provide symptomatic relief and support tear film stability during the treatment period.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2024-08-28
• Last updated: 2024-08-28

Locations

1 site across 1 country: Italy