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Rexon-Eye in Dry Eye

Efficacy and Safety of Rexon Eye in Asian Dry Eye

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04320563
Enrollment
40
Registered
2020-03-25
Start date
2019-07-20
Completion date
2022-08-30
Last updated
2022-10-26

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

Conditions

Dry Eye

Keywords

Rexon-eye

Brief summary

Resono Ophthalmic has developed Rexo-Eye in 2014, a QMR-based patented instrument which is hypothesised to stimulate physiological cellular regeneration and reactivate the tear system by stimulating and reactivating the lacrimal system, induce mild hyperthermia and massage effects which reactivate the tear and lipid secretion, targeting all arms of pathogenic mechanisms of dry eye disease. By improving cell migration and cell health, eye surface epithelial problems in dry eyes which are hard to reverse could hopefully be improved. It has been marked since 2016 as a medical device for the treatment of ocular surface disorders and patented in Italy and Europe, with other international patents pending. In this study, we aim to assess the efficacy and safety of Rexon-Eye in dry eye patients.

Detailed description

Dry eye disease, or ocular surface disease (OSD)as defined by the International Dry Eye Workshop (2007)1, is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance and tear film instability with potential damage to the ocular surface.1 There is an armantaranium of therapies different types of dry eyes such as lubricating eyedrops, moisture retention chamber, intense pulsed light which are not curative and require repetitive application. Recently, Quantum molecular resonance (QMR) has emerged as a new treatment for all types of dry eyes. This technology involves transpalpebral non-invasive high frequency microcurrent electrical stimulation of cells which stimulate natural regeneration of cells. With the application of low-power high-frequency oscillating electrical currents in the range of 4 to 64 megahertz, it works via the resonance effect by maximising delivery of energy to biological tissues by oscillating electrical fields without increasing temperature and eliciting biological responses.2, 3 A previous in-vitro study had evaluated the biophysical effects these high frequency electrical fields on cells in culture, which showed that it invoked a series of cellular massage of contractions and relaxations' which trigger cellular metabolism and stimulate tissues. Resono Ophthalmic has developed Rexo-Eye in 2014, a QMR-based patented instrument which is hypothesised to stimulate physiological cellular regeneration and reactivate the tear system by stimulating and reactivating the lacrimal system, induce mild hyperthermia and massage effects which reactivate the tear and lipid secretion, targeting all arms of pathogenic mechanisms of dry eye disease. By improving cell migration and cell health, eye surface epithelial problems in dry eyes which are hard to reverse could hopefully be improved. It has been marked since 2016 as a medical device for the treatment of ocular surface disorders and patented in Italy and Europe, with other international patents pending. Therapy takes place in the form of special mask electrodes applied to the patient's periorbital area worn for 20 minutes per session. Earlier studies have shown evidence to improve subjective and objective symptoms of dry eye disease as well as to successfully reduce the number of tear substitute eye drops over a 2 month treatment period with Rexon-Eye. However, these studies are mainly small scale and conducted in Western populations. There have been no other studies conducted in Asian populations on the efficacy and safety of the Rexon-Eye device in targeting dry eye disease. Thus our study aims to evaluate these two aims through this study, while determining patient satisfaction and acceptability of the technology and furthermore, exploring changes in the composite of tears before and after the Rexon-Eye device.

Interventions

PROCEDURERexon-eye

This treatment involved the technology known as quantum molecular resonance (QMR) which has emerged as a new treatment for all types of dry eyes.

Sponsors

Singapore National Eye Centre
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Both the participants and Investigators were masked. Only the study staff we helped with the Rexon-eye treatment was unmasked.

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

1. 21 years old and above; 2. Diagnosed with moderate dry eyes based on grade 3 and worse corneal fluorescein staining in the central interpalpebral region 3. Are on other eye drops (including artificial tears, topical ciclosporin, steroids), blephagel or lid warming solely for dry eyes, with no recent change in the last 1 month; 4. Willing to perform all eye examinations in this study; 5. Clear of

Design outcomes

Primary

MeasureTime frameDescription
SPEED Questionnaire to access the dry eye symptoms3 monthsTo assess the improvement of dry eye symptoms by SPEED questionnaire

Secondary

MeasureTime frameDescription
Acceptance of treatment (Rexon-eye)3 monthsParticipants will be asked to answer some questions on the satisfaction and acceptability of Rexon-eye treatment

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026