Clinical trial NCT06955806: Clinical Efficacy and Molecular Dynamics of Quantum Molecular Resonance (QMR) Electrotherapy in Dry Eye Management
Official title: Clinical Efficacy and Molecular Dynamics of Quantum Molecular Resonance (QMR) Electrotherapy in Dry Eye Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Disease (DED)
Keywords: Dry eye
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This project aims to investigate the clinical efficacy and molecular mechanisms of Quantum Molecular Resonance (QMR) electrotherapy in the management of dry eye disease (DED). DED is a multifactorial condition characterized by tear film instability, hyperosmolarity, inflammation, and neurosensory abnormalities, leading to discomfort and visual disturbances. The Rexon-Eye device, which utilizes QMR technology, has shown positive effects in alleviating dry eye symptoms. However, the exact mechanisms by which the stimulation of high-frequency electrical fields promotes improvement in DED remain unclear.

The research will be conducted as a longitudinal study involving 30 participants between the ages of 18 and 40 who meet the diagnostic criteria for DED. Participants will be randomly assigned to either a treatment group receiving QMR electrotherapy or a control group receiving a sham treatment, followed by a real treatment after second evaluation. Each participant in the treatment group will undergo a 20-minute weekly session for four weeks, with clinical evaluations and tear fluid collection occurring throughout the study.

Comprehensive assessments will be performed to evaluate tear film stability, lipid layer composition, ocular surface health and corneal sensitivity. Tear samples collected during the study will undergo molecular analysis using mass spectrometry to identify biochemical changes associated with QMR electrotherapy. Additionally, safety evaluations will be conducted at each visit to monitor potential adverse effects.

The study aims to determine whether QMR electrotherapy effectively improves clinical dry eye parameters while also uncovering the molecular changes in tear composition that may underlie its therapeutic effects. By exploring both clinical outcomes and biological mechanisms, this research will contribute valuable insights into the potential of QMR electrotherapy as an innovative treatment for dry eye disease.

Detailed description: Study Purpose and Potential Benefits:

Recently, a high frequency electrotherapy device using Quantum Molecular Resonance (QMR) technique, the Rexon-Eye was being developed for dry eye treatment. During the treatment, a low-intensity, high-frequency (a spectrum of frequencies ranging from 4 MHz to 64 MHz) electrical stimulations are applied on the epidermis of closed eyelids up to the lid border by specially designed goggles. Previous data showed that it could effectively improve symptoms and clinical signs of DED by increasing the tear secretion and improving the meibomian gland function. Compared with conventional DED management options such as lubricant and warm compress, previous studies proposed that this treatment may allow a possible capability to induce reactivation of physiological lacrimal functions instead of a short-term symptom relief.

The aims of this project are to investigate the clinical efficacy of QMR electrotherapy and the associated changes in tear proteomics and lipidomics in the management of dry eye disease.

Participant Eligibility

* aged 18 to 40 years old
* with habitual or best corrected visual acuity better than or equal to 6/9
* diagnosed as dry eye disease according to OSDI score (13 or above) and at least one positive result from dry eye assessment.

Exclusion criteria:

* history of ocular inflammation, trauma or surgery within 6 months
* long-term ocular medications
* current dry eye treatment
* uncontrolled, newly diagnosed systemic diseases
* with modified long-term medications within 6 months that are known to affect tear profile
* carrying active implantable devices (e.g., pacemakers and hearing aids) Contact lens wearers will be required to stop contact lens wear 1 month before the first evaluation and during the whole study period.

Study Procedure All the participants will be given a comprehensive dry eye assessment at the baseline visit (visit1). The assessment includes questionnaire filling, ocular surface checking, tear fluid examination and collection, and eyelid examination.

Participants will then be assigned to receive QMR treatment, which requires four sessions of treatment (on a weekly basis). Two post treatment comprehensive dry eye assessment will be scheduled one month after the 4th treatment, and three months after the 4th treatment.

Some participants may be given another four sessions of treatment (on a weekly basis), followed by two post treatment comprehensive dry eye assessment (also one month after the 4th treatment, and three months after the 4th treatment). In summary, some participants need to visit us 6 times in 5 months while the others may need to visit us 12 times in 8 months.

Parameters to be assessed in Comprehensive evaluation:

* Dry Eye Disease (DED) questionnaires - Ocular Surface Disease Index (OSDI)
* Non-invasive tear break-up time (NITBUT), tear meniscus height (TMH) - Keratograph® 5M
* Lipid layer thickness (LLT) and infrared meibography - idra® Ocular Surface Analyser
* External ocular health, ocular surface staining and lid margin assessment - Slit-lamp biomicroscopy and fluorescein strips
* Corneal sensitivity - Corneal Esthesiometer Brill

Potential Risk(s) or Discomfort(s) and their minimization(s):

EC certificate has certified the device safety of Rexon-Eye including electrical safety and electromagnetic compatibility, and also its clinical safety and effectiveness in treating DED. There is no anticipated risk to participants according to the current literature. All procedures will be conducted by a registered or student optometrist.

Some possible treatment induced effects included a sensation of about 3 to 4°C temperature increment underneath the treatment goggles; transient blurred vision after treatment caused by the pressure of the goggles to the closed eyelid; or transient eyelid skin redness for subjects with sensitive skin. From published results, all these effects should be reversible and disappear within minutes after the treatment is finished. Eye check will be done before and after the treatment to avoid any potential problem.

The treatment will be terminated if the subject is sensitive to the procedure or any unexpected adverse response is observed during the study.

Eligibility criteria: Inclusion Criteria:

* aged 18 to 40 years old
* with habitual or best corrected visual acuity better than or equal to 6/9
* diagnosed as dry eye disease according to OSDI score (13 or above) and at least one positive result from dry eye assessment.

Exclusion Criteria:

* history of ocular inflammation, trauma or surgery within 6 months
* long-term ocular medications
* current dry eye treatment
* uncontrolled, newly diagnosed systemic diseases
* with modified long-term medications within 6 months that are known to affect tear profile
* carrying active implantable devices (e.g., pacemakers and hearing aids)

Primary outcomes:
measure: clinical efficacy
timeFrame: From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months
Secondary outcomes:
measure: The associated tear proteomics and lipidomics changes after Electrotherapy
timeFrame: From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months
Other outcomes:
Locations:
Study officials:
References:
citation: Trivli A, Karmiris E, Dalianis G, Ruggeri A, Terzidou C. Evaluating the efficacy of Quantum Molecular Resonance (QMR) electrotherapy in mixed-type dry eye patients. J Optom. 2023 Apr-Jun;16(2):128-134. doi: 10.1016/j.optom.2022.06.003. Epub 2022 Jul 16.