Quantum Molecular Resonance Electrotherapy in Severe Dry Eye Disease (QMR)

November 3, 2023 updated by: Centro Oculistico Borroni
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VA
      • Gallarate, VA, Italy, 21013
        • Centro Oculistico Borroni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 - Treated Eye
Patients with treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular surface evaluation
Time Frame: 3 month
Tear meniscus height (TMH) measured in millimeters
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Oculistico Borroni

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2022

Primary Completion (Actual)

February 25, 2023

Study Completion (Actual)

February 25, 2023

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DB13385-2568932022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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