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NCT06119386 Clinical Trial

Quantum Molecular Resonance Electrotherapy in Severe Dry Eye Disease

Dry Eye Clinical Trial

— QMR  

Official title:
Quantum Molecular Resonance Electrotherapy in Severe Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06119386
Other study ID # DB13385-2568932022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 3, 2022
Est. completion date February 25, 2023

Study information
Verified date November 2023
Source Centro Oculistico Borroni
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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. In this prospective, interventional study, 81 patients will be 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 will include 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 at baseline, 1-month and 3-months follow-up.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date February 25, 2023
Est. primary completion date February 25, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion criteria: -> 18 years old with a self-reported history of DED - OSDI score = 33 points - TBUT less than 10 seconds. Exclusion criteria: - skin pathologies that prevent QRM treatment - corneal infection and corneal dystrophies - active ocular allergies - intraocular surgery or laser ocular surgery

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Rexon-Eye
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.

Locations
Country Name City State
Italy Centro Oculistico Borroni Gallarate VA

Sponsors (1)
Lead Sponsor Collaborator
Centro Oculistico Borroni

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular surface evaluation Tear meniscus height (TMH) measured in millimeters 3 month
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