Rexon-Eye in Dry Eye

NCT ID: NCT04320563

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-20
• Study Completion Date: 2022-08-30

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Full power treatment 4

These group of participants will receive the full power treatment 4

Group Type: ACTIVE_COMPARATOR

Rexon-eye

Intervention Type: PROCEDURE

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

Comparative Power 1

These group of participants will receive the comparative power 1 treatment

Group Type: PLACEBO_COMPARATOR

Rexon-eye

Intervention Type: PROCEDURE

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

Interventions

Rexon-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.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

Exclusion Criteria

1. Pregnant women

2. Patients carrying active implantable device (e.g., pacemakers and hearing aids)

3. Oncologic patients under treatment

4. Patient who underwent ocular surgery in the last month

5. Patients who are vegan or exclude egg in their diet

6. Patient who is on antibiotic or glaucoma eye drops

7. Patient who had ocular infection within 6 months

8. Any other specified reason as determined by clinical investigator

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Singapore National Eye Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Louis Tong

Clinician-Scientist, Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

Singapore Eye Research Institute

Locations

Singapore Eye Research Institute

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2019/2446

Identifier Type: REGISTRY

Identifier Source: secondary_id

R1624/21/2019

Identifier Type: -

Identifier Source: org_study_id