Quantum Molecular Resonance Effects on Patients With Dry Eye Disease

Dry Eye Syndromes Clinical Trial

Official title:

Quantum Molecular Resonance Effects on Patients With Dry Eye Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469932
• Other study ID #: AAA
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2021
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Assaf-Harofeh Medical Center
• Contact: Asaf Shemer, MD
• Phone: +972-8-9779620
• Email: ShemerasafMD[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
Israel	Shamir Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

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