Clinical trial NCT05469932: Quantum Molecular Resonance Effects on Patients With Dry Eye Disease
Official title: Quantum Molecular Resonance Effects on Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: Cornea
Dry Eye
Quantum Molecular Resonance
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Ocular Surface Disease Index (OSDI) Questionnaire
timeFrame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
Secondary outcomes:
measure: Change in Meibomian gland dysfunction Grading
timeFrame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
measure: Change in Corneal Staining
timeFrame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
measure: Change in Tear breakup time
timeFrame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
measure: Change in Schirmer with anesthesia
timeFrame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
measure: Change in Corrected visual acuity
timeFrame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Shamir Medical Center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.