Clinical utility of Quantum Molecular Resonance treatment for dry eye disease

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001187831

Enrollment

Registered

2021-09-03

Start date

2021-10-01

Completion date

2022-01-01

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Dry eye disease is one of the most common ophthalmic conditions presenting to eye care professionals and is becoming increasingly common with the ageing population. Affecting millions across the world, the burden of dry eye disease is significant, both financially and socially, with an adverse impact on productivity and quality of life for those affected. Existing management strategies do not meet current needs and there is an ongoing search for novel effective therapies that can provide relief from the symptoms and signs of dry eye disease. Quantum molecular resonance (QMR) offers such potential, through a unique mechanism of action, but evidence supporting its efficacy in treating dry eye through carefully controlled scientific studies is lacking. Aim: This trial aims to explore the efficacy of Quantum Molecular Resonance (QMR), (Rexon-Eye, Resono Ophthalmic, Italy) in relieving the signs and symptoms of dry eye disease of varying severity and across a range of aqueous deficient dry eye (ADDE) and evaporative dry eye (EDE) subtypes. Rexon-Eye (Resono Ophthalmic, Italy) is a commercially available and medically certified device, applied according to manufacturer's instructions. The outcome measurements performed during the study are all standard clinical tests. Study Design: Prospective, randomised, double-masked, parallel group, controlled clinical trial. We are recruiting up to 58 participants with signs and symptoms of dry eye; the study will be carried out by New Zealand registered optometrists in the Department of Ophthalmology at the University of Auckland.

Interventions

Rexon-Eye (Telea Electronic Engineering, Italy) is a commercially available device that generates Quantum Molecular Resonance (QMR) by high-frequency (4–64 MHz) and low-power (60–120 mJ/cm2/s) electrical currents. Each session of stimulation consists of electrodes being placed in the periorbital area of both eyes via a ‘goggle like’ device. Its proposed mechanism of action is based on the resonance effect, which is the delivery of energy to biological tissues by oscillating electric fields without significantly increasing the temperature, and eliciting biological responses to achieve both pathophysiological and potentially therapeutic benefits. In this prospective, double-masked, placebo-controlled trial, participants will receive either 4 x weekly Rexon-Eye treatments or 4 weekly sham treatments (with heat to mimic QMR application, but omitting the application of the low power, high frequency stimulation), over the course of one month. Treatment will be applied by a trained individual uninvolved in collecting study outcomes. Three ‘follow-up’ visits are arranged at 1 month, 2 months, and 3 months after the fourth treatment session, to measure clinical outcomes only.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Participants with symptomatic dry eye caused by evaporative causes (e.g. meibomian gland dysfunction) or aqueous deficient causes (e.g. Sjögren's syndrome). Participants will be required to: • Meet TFOS DEWS II criteria for dry eye diagnosis • Be willing and able to follow the protocol accurately • Be willing to minimise application of dry eye treatments beyond the study treatment TFOS DEWS II dry eye diagnosis: Adult participants meeting the criteria for dry eye disease according to the TFOS DEWS II diagnostic criteria (symptoms: OSDI greater or equal to 13, DEQ-5 greater or equal to 6; plus one or more signs: non-invasive breakup time (NIBUT) less than 10s, osmolarity greater than 308 or interocular diff of greater or equal to 8; greater than 5 spots corneal staining with NaFl, greater than 9 spots conjunctival staining with lissamine green, lid margin staining (lid wiper epitheliopathy) of greater or equal to 2mm in length and greater or equal to 25% lid margin width will be recruited. Subclassification according to dry eye status (ADDE, EDE or mixed) and severity (mild-moderate vs moderate-severe) will be determined according to established cut-offs. For EDE: Clinically significant signs of MGD: (eyelid margin or mucocutaneous junction abnormalities, meibomian gland orifice capping, and/or decreased expressed meibum quality). For ADDE: reduced tear meniscus height (less than 0.2mm).

Exclusion criteria

Exclusion Criteria: • OPAS score greater than 70% on questions 1, 4 or 7 indicating possible ocular neuropathic pain that may be unresponsive to treatment • Contact lens wear, or application of topical therapies other than dry eye drops within two weeks of the eligibility assessment or during the trial • Use of systemic medications known to affect the ocular surface or tear production • Current or planned pregnancy or lactation during the study • History of major systemic, dermatologic or ocular conditions • Ocular surgery or dermatologic treatments in the previous three months or planned during the treatment period. • Unwillingness to refrain from dye drop application on study visit days • Use of warm compresses or lid hygiene unless applied regularly as part of a stable regime for greater than 3 months and continued throughout trial, but not within 24 hours of study visits • LipiFlow, IPL (Intense Pulsed Light) or investigational treatment for dry eye disease within 6 months of study start • Lid debridement or therapeutic meibomian gland expression within 1 month of study start

Outcome results