Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05469932
Status:
UNKNOWN
Last Update Posted:
2022-07-22
First Post:
2022-03-03
Brief Title:
Quantum Molecular Resonance Effects on Patients With Dry Eye Disease
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Quantum Molecular Resonance Effects on Patients With Dry Eye Disease
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None