Clinical trial NCT06576245: Efficacy of Quantum Molecular Resonance Combined With Intense Pulsed Light in Mixed Dry Eye
Official title: Efficacy of Quantum Molecular Resonance Combined With Intense Pulsed Light in Mixed Dry Eye: A Prospective Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Mixed Dry Eye
Quantum Molecular Resonance (QMR)
Intense Pulsed Light (IPL)
Tear Film Stability
Dry Eye Treatment
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Ocular Surface Disease Index (OSDI) Score
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Change in Lipid Layer Thickness (LLT)
timeFrame: Baseline, 1 month, 3 months
measure: Change in Non-Invasive Tear Film Break-Up Time (NIBUT)
timeFrame: Baseline, 1 month, 3 months
measure: Change in Schirmer I Test (ST) Score
timeFrame: Baseline, 1 month, 3 months
Other outcomes:
measure: Correlation Between Clinical Endpoints and Symptom Improvement
timeFrame: 3 months
Locations:
city: Girifalco
country: Italy
facility: Tedesco Eye Center
state: Catanzaro
Study officials:
affiliation: University of Seville
name: José-María Sánchez-González, OD, MsC, PhD
role: STUDY_CHAIR
affiliation: University of Seville
name: Carlos Rocha-de-Lossada, MD PhD
role: STUDY_DIRECTOR
References: