Quantum Molecular Resonance Electrotherapy in Severe Dry Eye Disease
QMR
1 other identifier
interventional
81
1 country
1
Brief Summary
To evaluate the efficacy and safety of Quantum Molecular Resonance (QMR) treatment in patients with severe dry eye disease (DED), as well as its effects on aqueous-deficient (ADDE), evaporative (EDE) and mixed (MDE) dry eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2023
CompletedFirst Submitted
Initial submission to the registry
October 17, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedNovember 7, 2023
November 1, 2023
4 months
October 17, 2023
November 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ocular surface evaluation
Tear meniscus height (TMH) measured in millimeters
3 month
Study Arms (1)
Group 1 - Treated Eye
EXPERIMENTALPatients with treatment
Interventions
In this prospective, interventional study, 81 patients were randomly allocated to received 4 treatment sessions of QMR at one-week intervals (Rexon-Eye ® , Resono Ophthalmic, Trieste, Italy) (QRM group) or tear substitute 4 times daily, containing 0.15% sodium hyaluronate and 3% trehalose (Thealoz Duo ® , Thea Pharma, France) (SH-TH group). Outcomes measures included ocular surface disease index (OSDI) questionnaire, tear meniscus height (TMH), tear breakup time (TBUT), non-invasive breakup time (NIBUT), corneal fluorescein staining (CFS), lipid layer thickness (LLT), tear film osmolarity (OSM) and meibomian gland dysfunction (MGD) grade, which were assessed at baseline, 1-month and 3-months follow-up.
Eligibility Criteria
You may qualify if:
- \> 18 years old with a self-reported history of DED
- OSDI score ≥ 33 points
- TBUT less than 10 seconds.
You may not qualify if:
- skin pathologies that prevent QRM treatment
- corneal infection and corneal dystrophies
- active ocular allergies
- intraocular surgery or laser ocular surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Oculistico Borroni
Gallarate, VA, 21013, Italy
Related Publications (2)
Foo VHX, Liu YC, Tho B, Tong L. Quantum molecular resonance electrotherapy (Rexon-Eye) for recalcitrant dry eye in an Asian population. Front Med (Lausanne). 2023 Sep 12;10:1209886. doi: 10.3389/fmed.2023.1209886. eCollection 2023.
PMID: 37771976BACKGROUNDBallesteros-Sanchez A, Sanchez-Gonzalez JM, Tedesco GR, Rocha-De-Lossada C, Russo F, Spinelli A, Ingrande I, Borroni D. Efficacy and Safety of Quantum Molecular Resonance Electrotherapy in Patients with Aqueous-Deficient, Evaporative and Mixed-Type Dry Eye: A Randomized Interventional Study. Ophthalmol Ther. 2024 Feb;13(2):495-507. doi: 10.1007/s40123-023-00868-w. Epub 2023 Dec 19.
PMID: 38113022DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2023
First Posted
November 7, 2023
Study Start
November 3, 2022
Primary Completion
February 25, 2023
Study Completion
February 25, 2023
Last Updated
November 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share