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OpenTrials
Completed

NCT Number: NCT06119386

Quantum Molecular Resonance Electrotherapy in Severe Dry Eye Disease

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.

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Key information

Conditions

Dry Eye Corneal Diseases Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Oculistico Borroni

Gallarate, VA, 21013, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rexon-Eye

Device

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.

Primary outcomes

  1. Ocular surface evaluation

    Time frame: 3 month

    Tear meniscus height (TMH) measured in millimeters

Sponsors and collaborators

Lead sponsor

Centro Oculistico Borroni

Other

Registry information

Acronym: QMR

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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