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NCT06955806
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Clinical Efficacy and Molecular Dynamics of Quantum Molecular Resonance (QMR) Electrotherapy in Dry Eye Management

Sponsor: The Hong Kong Polytechnic University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-05-31

Completion Date

2026-12-31

Last Updated

2025-09-12

Healthy Volunteers

No

Interventions

DEVICE

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

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.

Locations (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong