Quantum Molecular Resonance Effects on Patients With Dry Eye Disease

Shamir Medical Center (Assaf-Harofeh)

Status: Enrolling

Conditions: Dry Eye Syndromes

Treatments: Device: Rexon device

Study type: Interventional

Funder types: Other

Identifiers

NCT05469932

AAA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

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.

Treatment:

Device: Rexon device

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: Rexon device