Quantum Molecular Resonance Effects on Patients With Dry Eye Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: Rexon device

Detailed Description

In this study, the investigators aim to examine the efficacy of the Rexon eye device for the treatment of dry eye signs and symptoms in a randomized double-blind placebo-controlled fashion among a cohort of prospectively recruited patients with dry eye. The control group will receive a similar application of treatment with the device goggles disconnected from the device, effectively receiving no treatment. The treatment will be performed by research assistants following thorough instruction by the manufacturing company representatives and/or provided material. Participants will be actively questioned on any harms or side effects in every meeting.

Outcomes will be assessed based on clinical signs and by validated questionnaires on dry eye symptoms (OSDI).

Informed written consent will be obtained from all participants involved in the study prior to enrollment. The goal of the study is to evaluate the Rexon device as a possible additional treatment option for patients with dry eye or to establish it has no added benefit.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asaf Shemer, MD; Phone Number: +972-8-9779620; Email: ShemerasafMD@gmail.com
• Study Contact Backup: Name: Adi Einan; Phone Number: +972-8-9779620; Email: ADI.einan@gmail.com

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Shamir Medical Center
    • Contact: Asaf Shemer; Phone Number: +972-8-9779620; Email: ShemerasafMD@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment; 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; Rexon device for 20 minutes each session. A total of 4 sessions with one week apart from each other.; Other Names: Resono Ophthalmic
Placebo Comparator: Placebo; 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; Rexon device for 20 minutes each session. A total of 4 sessions with one week apart from each other.; Other Names: Resono Ophthalmic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Meibomian gland dysfunction Grading	Min = 0. Max =4. Low score: low Meibomian gland dysfunction (normal) High score: Meibomian gland dysfunction (pathology)	At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
Change in Corneal Staining	We measure the amount of fluorescein dots (score 0 for 0 dots, score 1 for 1-5 dots, score 2 for 6-30 dots, score 3 for >30 dots) Additional 1 point for - Patches of confluent staining Additional 1 point for - Staining in the pupillary area Additional 1 point for - One or more filament Min = 0. Max =6. Low score: Clear cornea (normal) High score: pathological cornea (pathology)	At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
Change in Tear breakup time	Measures the number of seconds for the fluorescein to break and thus assesses the stability of tear film. Min = 0. Max = 20. Low score: Tear film instability (pathology) High score: Normal Tear film stability (normal)	At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
Change in Schirmer with anesthesia	The Schirmer's test evaluates aqueous tear production. It is helpful in the assessment of patients with signs and/or symptoms of dry eye - as it can determine whether surface dryness is due to reduced tear production from the lacrimal glands as opposed to some other cause. The Schirmer basal secretion test was performed for each patient in both eyes in the following manner: Topical anesthetic was applied to the eye, and the conjunctival fornix was dried with a cotton tip applicator. After a 2-minute waiting period, the paper strip was folded and placed between the lower eyelid and the globe at the junction between the middle and lateral thirds of the eyelid. After 5 minutes, the filter paper is removed and the amount of wetting from the fold is measured (mm) We used the standard (no. 41 Whatman) filter paper. Min = 0 mm Max = 30 mm Low score: Low tear secretion (pathology) High score: Normal tear secretion (normal)	At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
Change in Corrected visual acuity	LogMAR scale. Min = 0. Max = 1. Low score: Normal visual acuity (normal) High score: Imparied visual acuity (pathology)	At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cornea; Dry Eye; Quantum Molecular Resonance
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: AAA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No