Clinical Efficacy and Molecular Dynamics of Quantum Molecular Resonance (QMR) Electrotherapy in Dry Eye Management

NCT06955806 | Active Not Recruiting

• 1 other identifier: HSEARS20250209003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease (DED)

Keywords

Dry eye

Outcome Measures

Primary Outcomes (1)

• clinical efficacy

  Ocular Surface Disease Index

  From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months

Secondary Outcomes (1)

• The associated tear proteomics and lipidomics changes after Electrotherapy

  From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

Following a comprehensive evaluation, the treatment group will undergo a 20-minute treatment once per week for four weeks.

Device: The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology

Control Arm

SHAM COMPARATOR

Following a comprehensive evaluation, the sham treatment group will firstly undergo a 20-minute sham treatment once per week for four weeks. Two additional comprehensive evaluations and tear fluid collections will be conducted one month and three months after the completion of the treatment period. After the three-month post-treatment evaluation, the control group will receive four weekly treatments.

Device: The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology

Interventions

The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology DEVICE

The device has received EC certification as a medical device for the treatment of ocular surface disorders. It will deliver a low-intensity alternating electrical current (ranging from 4 MHz to 64 MHz) to targeted biological tissue via contact electrodes. Previous studies have shown the effectiveness of this treatment in alleviating dry eye symptoms, both subjectively and objectively.

Control Arm; Treatment Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 35851496 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Practice

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)