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Clinical Trials/NCT06119386
NCT06119386CompletedNot Applicable

Quantum Molecular Resonance Electrotherapy in Severe Dry Eye Disease

Centro Oculistico Borroni2 sites in 1 country81 target enrollmentStarted: November 3, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
81
Locations
2
Primary Endpoint
Ocular surface evaluation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Ocular surface evaluation

Time Frame: 3 month

Tear meniscus height (TMH) measured in millimeters

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centro Oculistico Borroni
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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