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.

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: Quantum Molecular Resonance (QMR) Therapy; Device: Intense Pulsed Light (IPL) Therapy; Drug: Tear Substitute Treatment (Supportive Therapy)

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catanzaro
    • Girifalco, Catanzaro, Italy, 88024
      • Tedesco Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Ocular Surface Disease Index (OSDI) Score	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.	Baseline, 1 month, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lipid Layer Thickness (LLT)	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.	Baseline, 1 month, 3 months
Change in Non-Invasive Tear Film Break-Up Time (NIBUT)	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.	Baseline, 1 month, 3 months
Change in Schirmer I Test (ST) Score	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.	Baseline, 1 month, 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between Clinical Endpoints and Symptom Improvement	This exploratory outcome measure will analyze the correlation between clinical endpoints (such as NIBUT, LLT, and ST) and the improvement in OSDI scores. The goal is to determine which clinical measures most strongly predict symptom improvement.	3 months

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Study Chair: José-María Sánchez-González, OD, MsC, PhD, University of Seville; Study Director: Carlos Rocha-de-Lossada, MD PhD, University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Tear Film Stability; Mixed Dry Eye; Quantum Molecular Resonance (QMR); Intense Pulsed Light (IPL); Dry Eye Treatment
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: USeville_2024_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to confidentiality concerns and the lack of a data-sharing agreement in place. However, aggregated results and key findings will be published in peer-reviewed journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No