QMR: Quantum Molecular Resonance Electrotherapy in Severe Dry Eye Disease

• Sponsor: Centro Oculistico Borroni (Other)
• Overall Status: Completed
• CT.gov ID: NCT06119386
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.7
• Patients Per Site Per Month: 21.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Device: Rexon-Eye	N/A

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
• Actual Enrollment: 81 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Quantum Molecular Resonance Electrotherapy in Severe Dry Eye Disease
• Actual Study Start Date: Nov 3, 2022
• Actual Primary Completion Date: Feb 25, 2023
• Actual Study Completion Date: Feb 25, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Ocular surface evaluation [3 month]

   Tear meniscus height (TMH) measured in millimeters

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Oculistico Borroni	Gallarate	VA	Italy	21013

Sponsors and Collaborators

• Centro Oculistico Borroni

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Centro Oculistico Borroni
• ClinicalTrials.gov Identifier: NCT06119386
• Other Study ID Numbers: DB13385-2568932022
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centro Oculistico Borroni: Cornea; Dry Eye
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases

Study Results

No Results Posted as of Nov 7, 2023