Efficacy of Quantum Molecular Resonance Combined With Intense Pulsed Light in Mixed Dry Eye
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedFirst Submitted
Initial submission to the registry
August 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 28, 2024
CompletedAugust 28, 2024
August 1, 2024
6 months
August 25, 2024
August 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Change in Schirmer I Test (ST) Score
Baseline, 1 month, 3 months
Other Outcomes (1)
Correlation Between Clinical Endpoints and Symptom Improvement
3 months
Study Arms (1)
Combination Treatment: Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL)
EXPERIMENTALParticipants 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.
Interventions
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.
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tedesco Eye Center
Girifalco, Catanzaro, 88024, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
José-María Sánchez-González, OD, MsC, PhD
University of Seville
- STUDY DIRECTOR
Carlos Rocha-de-Lossada, MD PhD
University of Seville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Vision Science Research Group
Study Record Dates
First Submitted
August 25, 2024
First Posted
August 28, 2024
Study Start
September 1, 2023
Primary Completion
February 28, 2024
Study Completion
February 28, 2024
Last Updated
August 28, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share
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.