Quantum Molecular Resonance Effects on Patients With Dry Eye Disease

NCT05469932 | Unknown

• 1 other identifier: AAA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The Rexon Eye device (Resono Ophthalmic Inc, Trieste, Italy) is a new device based on QMR technology. Quantum Molecular Resonance (QMR) is a technique in which low-intensity, high-frequency electric currents are administered to a biological tissue through contact electrodes. The device applies stimulation to the epidermis of closed eyelids up to the lid margin by means of specially designed goggles. Previous studies have shown that it is relatively safe with high patient satisfaction. Preliminary studies have also shown it is effective for accelerating healing in chronic wounds and treating dry eye symptoms.

Conditions

Dry Eye Syndromes

Keywords

Cornea; Dry Eye; Quantum Molecular Resonance

Outcome Measures

Primary Outcomes (1)

• Change in Ocular Surface Disease Index (OSDI) Questionnaire

  A validated questionnaire that assess the symptoms of ocular irritation in dry eye disease. and how they affect functioning related to vision. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease

  At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)

Secondary Outcomes (5)

• Change in Meibomian gland dysfunction Grading

  At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)

• Change in Corneal Staining

  At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)

• Change in Tear breakup time

  At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)

• Change in Schirmer with anesthesia

  At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)

• Change in Corrected visual acuity

  At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Pre-treatment medical examination by an ophthalmologist and self-filled questionnaire. Four treatment sessions. Each session includes 20 minutes with the instrument active at power level 4. Post-treatment medical examination by an ophthalmologist and self-filled questionnaire.

Device: Rexon device

Placebo

PLACEBO COMPARATOR

Pre-treatment medical examination by an ophthalmologist and self-filled questionnaire. Four treatment sessions. Each session includes 20 minutes with the instrument active at power level 0. Post-treatment medical examination by an ophthalmologist and self-filled questionnaire.

Device: Rexon device

Interventions

Rexon device DEVICE

Rexon device for 20 minutes each session. A total of 4 sessions with one week apart from each other.

Also known as: Resono Ophthalmic

Placebo; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above the age of 18 years
• Patients who are willing and able to consent and adhere to the research plan
• Patients diagnosed with dry eye or patients who are at risk for dry eye

You may not qualify if:

• Active infection of the eyelid or periorbital area
• Patients who are pregnant or lactating
• Patients under the age of 18
• Those scheduled for (\<30 days) or immediately after (\<30 days) ocular surgery (excluding cataract and eyelid surgery)
• Patient who do not adhere to all four treatment sessions.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (4)

• Ferrari G, Colucci A, Barbariga M, Ruggeri A, Rama P. High Frequency Electrotherapy for the Treatment of Meibomian Gland Dysfunction. Cornea. 2019 Nov;38(11):1424-1429. doi: 10.1097/ICO.0000000000002063.

  PMID: 31356415 BACKGROUND

• Pedrotti E, Bosello F, Fasolo A, Frigo AC, Marchesoni I, Ruggeri A, Marchini G. Transcutaneous periorbital electrical stimulation in the treatment of dry eye. Br J Ophthalmol. 2017 Jun;101(6):814-819. doi: 10.1136/bjophthalmol-2016-308678. Epub 2016 Sep 22.

  PMID: 27660329 BACKGROUND

• Sella S, Adami V, Amati E, Bernardi M, Chieregato K, Gatto P, Menarin M, Pozzato A, Pozzato G, Astori G. In-vitro analysis of Quantum Molecular Resonance effects on human mesenchymal stromal cells. PLoS One. 2018 Jan 2;13(1):e0190082. doi: 10.1371/journal.pone.0190082. eCollection 2018.

  PMID: 29293552 BACKGROUND

• Shemer A, Altarescu A, Nusbaum L, Vardi M, Dubinsky-Pertzov B, Hecht I, Or L, Einan-Lifshitz A, Pras E. Quantum Molecular Resonance Effects on Patients With Dry Eye Disease: A Randomized Controlled Trial. Cornea. 2024 Sep 1;43(9):1144-1149. doi: 10.1097/ICO.0000000000003443. Epub 2023 Dec 28.

  PMID: 38166187 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Dry Eye Syndromes; Corneal Diseases

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Asaf Shemer, MD

CONTACT

+972-8-9779620; ShemerasafMD@gmail.com

Adi Einan

CONTACT

+972-8-9779620; ADI.einan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient does not know wheater they are on treatment or placebo arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician in the Ophthalmology Department

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: July 22, 2022
• Study Start: February 14, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

IL (1)