Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease
- Conditions
- Dry Eye Syndromes
- Registration Number
- NCT06089317
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
<br><br> 1. At least one eye of subjects meets DED diagnostic criteria as the Tear Film and<br> Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS II); and<br><br> 2. Ocular Surface Disease Index (OSDI)=13 and <33; and<br><br> 3. The age range between years 18-80, no sex limitation; and<br><br> 4. Symptoms of dry eye for at least 6 months; and<br><br> 5. Can complete the questionnaires independently and understand Chinese or English.<br><br>Exclusion criteria:<br><br> 1. Had or currently suffering from other concomitant ocular surface diseases, including<br> chronic conjunctivitis, ocular rosacea, cicatricial pemphigoid, graft-versus-host<br> disease, limbal stem cell deficiency, and severe ocular allergy;<br><br> 2. Received any refractive surgery and corneal surgery before, including corneal<br> transplant; or any eye surgery in the past 6 months;<br><br> 3. Receiving DED-related medications, including topical steroid eyedrops, topical<br> antibiotics, topical cyclosporin A, and topical diquafosol;<br><br> 4. Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy in<br> the past 12 months;<br><br> 5. Received topical antiglaucomatous treatment in the past 12 months<br><br> 6. Plans to use contact lenses during treatment and follow-up periods or used contact<br> lenses 2 weeks before the baseline measurement and recruitment;<br><br> 7. Had or currently suffering from severe cardiopulmonary disease, liver and kidney<br> dysfunction, and severe blood system diseases;<br><br> 8. Suffering from glucose-6-phosphate dehydrogenase deficiency (G6PD);<br><br> 9. Had or currently suffering from specific respiratory diseases, e.g. emphysema,<br> bronchitis, asthma, chronic obstructive pulmonary disease, bronchial dilatation;<br><br> 10. Has adverse reaction history to herbs used in this study before;<br><br> 11. Whose TCM constitution is manifested as yang-deficiency or diagnosed by TCM<br> practitioners that their TCM syndrome is not suitable for the atomization treatment;<br><br> 12. Pregnancy, preparation for pregnancy, or lactation;
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Ocular Surface Disease Index (OSDI);Change in Non-invasive Tear Break-up Times (NIBUT)
- Secondary Outcome Measures
Name Time Method Change in Ocular Surface Disease Index (OSDI);Change in symptom Assessment iN Dry Eye (SANDE, modified);Change in 36-Item Short Form Health Survey (SF-36);Change in the Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH);Change in Non-Invasive Tear Break Up Times (NIBUT);Changes in Tear Meniscus Height (TMH);Changes in Bulbar Redness;Changes in Lipid Layer Thickness;Changes in Partial Blinking Rate;Changes in Meiboscore;Change in Tear Film Breakup Time (TBUT);Change in Corneal and Conjunctival Fluorescein Staining;Change in Expressibility of Meibomian Glands in the Meibomian Glands Yielding Liquid Secretion (MGYLS) (the inferior eyelid);Change in Quality of Expressed Meibum;Change in Lid Margin and Eyelash Abnormalities;Change in Tear Film Osmolarity (TFO);Changes in Schirmer I test;Changes in Matrix metallopeptidase 9 (MMP-9);Adverse events (AEs)