RECRUITINGINTERVENTIONAL
Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease
About This Trial
In this study, the initial tear proteome profiles in Dry Eye Disease (DED) patients, the safety and effectiveness of using an EC certificate DED treatment device in DED management, together with the associated global tear proteome changes, will be investigated.
Who May Be Eligible (Plain English)
Who May Qualify:
- OSDI score ≥ 13, and
- Fail one of the three diagnostic tests:
- Non-invasive tear break-up time (NITBUT) less than 10s;
- Tears osmolarity higher than or equals to 308 mOsm/L or inter-ocular difference \> 8 mOsm/L;
- When assessing with slit lamp, shows more than 9 spots of conjunctival stain with lissamine green, more than 5 spots of corneal stain with fluorescein or lid wiper epitheliopathy (LWE) with lissamine green ≥ 2 mm in length and/or ≥ 25% sagittal width.
Who Should NOT Join This Trial:
- Any active ocular infections, inflammations or anomalies in eyelid;
- Pregnant or lactating;
- Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months;
- Carrying active implantable devices (e.g., pacemakers and hearing aids)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* OSDI score ≥ 13, and
* Fail one of the three diagnostic tests:
* Non-invasive tear break-up time (NITBUT) less than 10s;
* Tears osmolarity higher than or equals to 308 mOsm/L or inter-ocular difference \> 8 mOsm/L;
* When assessing with slit lamp, shows more than 9 spots of conjunctival stain with lissamine green, more than 5 spots of corneal stain with fluorescein or lid wiper epitheliopathy (LWE) with lissamine green ≥ 2 mm in length and/or ≥ 25% sagittal width.
Exclusion Criteria:
* Any active ocular infections, inflammations or anomalies in eyelid;
* Pregnant or lactating;
* Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months;
* Carrying active implantable devices (e.g., pacemakers and hearing aids)
Treatments Being Tested
DEVICE
The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology
The device has received EC certification as a medical device for the treatment of ocular surface disorders. It will deliver a low-intensity alternating electrical current (ranging from 4 MHz to 64 MHz) to targeted biological tissue via contact electrodes. Previous studies have shown the effectiveness of this treatment in alleviating dry eye symptoms, both subjectively and objectively.
Locations (1)
The Hong Kong Polytechnic University, Hong Kong,
Hong Kong, Hong Kong