Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease
The Hong Kong Polytechnic University
75 participants
Jan 1, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria4
- 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)
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07175909