Rexon-Eye in Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

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.
    

Intervention name(s): Rexon-eye
Intervention type(s): Procedure
Intervention description(s): This treatment involved the technology known as quantum molecular resonance (QMR) which has emerged as a new treatment for all types of dry eyes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rexon-eye