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Dry Eye SyndromesNCT05469932

Quantum Molecular Resonance Effects on Patients With Dry Eye Disease

A study testing Rexon device in people with Dry Eye Syndromes, run by Assaf-Harofeh Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Syndromes
What is being tested?
Rexon device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteIsrael
Study dates
14 Feb 2021to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Asaf Shemer, MD contact

+972-8-9779620

ShemerasafMD@gmail.com

Adi Einan contact

+972-8-9779620

ADI.einan@gmail.com

Israel1 site, 1 recruiting

  • Shamir Medical Center

    Tel Aviv

    Asaf Shemer, +972-8-9779620, ShemerasafMD@gmail.com

    Recruiting

Other trials in Israel

About this study

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.

Read the 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.

Being tested
Rexon device
Keywords
Cornea, Dry Eye, Quantum Molecular Resonance
Medical subject headings
Dry Eye Syndromes, Corneal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rexon deviceDevice

    Also called Resono Ophthalmic

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

Study groups in NCT05469932
Study groupRoleWhat they receive
TreatmentActive comparatorPre-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.
Receives: Device: Rexon device
PlaceboPlacebo comparatorPre-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.
Receives: Device: Rexon device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (5)

  1. Change in Meibomian gland dysfunction Grading

    Min = 0. Max =4. Low score: low Meibomian gland dysfunction (normal) High score: Meibomian gland dysfunction (pathology)

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

  2. 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)

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

  3. 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)

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

  4. 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)

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

  5. Change in Corrected visual acuity

    LogMAR scale.

    Min = 0. Max = 1. Low score: Normal visual acuity (normal) High score: Imparied visual acuity (pathology)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2022
  2. Study start14 Feb 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05469932
Sponsor's protocol ID
AAA
Status last verified
Jul 2022
First submitted
3 Mar 2022
Last updated
22 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 31356415

  • 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.

    PubMed 27660329

  • 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.

    PubMed 29293552

  • 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.

    PubMed 38166187

Questions about this trial

What is this clinical trial studying?

A study testing Rexon device in people with Dry Eye Syndromes, run by Assaf-Harofeh Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Asaf Shemer, MD (+972-8-9779620, ShemerasafMD@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Ocular Surface Disease Index (OSDI) Questionnaire (time frame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05469932, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.

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