AzTrials
AzTrials

Dry EyeNCT06576245

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

A study testing Quantum Molecular Resonance (QMR) Therapy, Intense Pulsed Light (IPL) Therapy and Tear Substitute Treatment (Supportive Therapy) in people with Dry Eye, run by University of Seville at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye
What is being tested?
Quantum Molecular Resonance (QMR) Therapy, Intense Pulsed Light (IPL) Therapy and Tear Substitute Treatment (Supportive Therapy)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteItaly
Study dates
1 Sep 2023to 28 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 12Show fewer
  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Tedesco Eye Center

    Girifalco, Catanzaro, 88024

Other trials in Italy

About this study

Official title: 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.

Read the 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
Being tested
Quantum Molecular Resonance (QMR) Therapy, Intense Pulsed Light (IPL) Therapy, Tear Substitute Treatment (Supportive Therapy)
Keywords
Mixed Dry Eye, Quantum Molecular Resonance (QMR), Intense Pulsed Light (IPL), Tear Film Stability, Dry Eye Treatment
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quantum Molecular Resonance (QMR) TherapyDevice

    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) TherapyDevice

    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).

  • Tear Substitute Treatment (Supportive Therapy)Drug

    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.

Study groups in NCT06576245
Study groupRoleWhat they receive
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.
Receives: Device: Quantum Molecular Resonance (QMR) Therapy; Device: Intense Pulsed Light (IPL) Therapy; Drug: Tear Substitute Treatment (Supportive Therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 1 month, 3 months

Secondary outcomes (3)

  1. 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.

    Measured: Baseline, 1 month, 3 months

  2. 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.

    Measured: Baseline, 1 month, 3 months

  3. 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.

    Measured: Baseline, 1 month, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start1 Sep 2023
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06576245
Sponsor's protocol ID
USeville_2024_01
Status last verified
Aug 2024
First submitted
25 Aug 2024
Last updated
28 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Quantum Molecular Resonance (QMR) Therapy, Intense Pulsed Light (IPL) Therapy and Tear Substitute Treatment (Supportive Therapy) in people with Dry Eye, run by University of Seville at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Ocular Surface Disease Index (OSDI) Score (time frame: Baseline, 1 month, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06576245.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in