Evaluating the efficacy of Quantum Molecular Resonance (QMR) electrotherapy in mixed-type dry eye patients.
Alexandra Trivli, Efthymios Karmiris, Georgios Dalianis...
https://pubmed.ncbi.nlm.nih.gov/35851496Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07175909
Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease
Led by The Hong Kong Polytechnic University · Updated on 2025-09-16
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Dry Eye Disease (DED) to better understand tear protein profiles and to evaluate the safety and effectiveness of a new treatment device certified in Europe. Current diagnosis methods for DED rely on questionnaires and tear tests that may not always match patient symptoms well, so this study aims to find more reliable ways to diagnose and manage DED using a special electrotherapy device. The treatment device, called Rexon-Eye, uses Quantum Molecular Resonance technology to apply low-intensity, high-frequency electrical stimulation through goggles worn over closed eyelids. The study will involve 75 adults aged 18 to 65, including 50 DED patients and 25 without the disease as controls. Participants with DED will be randomly assigned to receive either the active treatment or a sham treatment once a week for four weeks. After the initial treatments and follow-ups at one and three months, the sham group will also receive the active treatment followed by additional evaluations. Participants will undergo thorough eye evaluations, including tear collection using Schirmer strips before and after treatment. Researchers will analyze changes in tear proteins using mass spectrometry and assess clinical outcomes up to eight months from enrollment. The study will monitor safety and effectiveness through clinical signs and patient symptoms, with follow-up visits scheduled after treatments to track any lasting effects.
CONDITIONS
Brief Title
Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Ocular Surface Disease Index (OSDI) score of 13 or higher
- Failed at least one of the following diagnostic tests: Non-invasive tear break-up time less than 10 seconds; Tear osmolarity equal to or above 308 mOsm/L or inter-ocular difference greater than 8 mOsm/L; Conjunctival or corneal staining or lid wiper epitheliopathy meeting specified thresholds
You will not qualify if you...
- Any active eye infections, inflammations, or eyelid abnormalities
- Pregnant or breastfeeding women
- Uncontrolled or newly diagnosed systemic diseases or changes in long-term medications within the past 6 months
- Presence of active implantable devices such as pacemakers or hearing aids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Implementation
Duration - 4 weeks
Participants receive weekly 20-minute treatments using the Rexon-Eye device or sham treatments for four weeks.
4 weekly visits (in-person)
Follow-up
Duration - 3 months
Participants are evaluated for clinical efficacy and tear proteome changes at one month and three months after the final treatment.
2 visits (in-person)
Implementation
Duration - 4 weeks
Sham treatment group receives four weekly 20-minute treatments using the Rexon-Eye device after the three-month follow-up.
4 weekly visits (in-person)
Follow-up
Duration - Duration not specified
Sham treatment group undergoes two additional evaluation visits for clinical efficacy and tear proteome changes after their treatments.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
The Hong Kong Polytechnic University, Hong Kong,
Hong Kong, Hong Kong
Actively Recruiting
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Research Team
S
Sung Hei Jimmy Tse
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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