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Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease
Bu çalışma, kuru göz hastalığı (dry eye disease) olan kişilerde çeşitli bitkisel karışımlarla uygulanan geleneksel Çin tıbbı ultrasonik atomizasyon tedavisini, yapay gözyaşı ve plasebo ile karşılaştırarak değerlendirmiştir. Çalışmaya en az 6 aydır kuru göz belirtileri olan, 18-80 yaş arası kişiler katılmıştır. Faz uygulanmayan bir çalışma olup tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion criteria: 1. At least one eye of subjects meets DED diagnostic criteria as the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS II); and 2. Ocular Surface Disease Index (OSDI)≥13 and \<33; and 3. The age range between years 18-80, no sex limitation; and 4. Symptoms of dry eye for at least 6 months; and 5. Can complete the questionnaires independently and understand Chinese or English. Exclusion criteria: 1. Had or currently suffering from other concomitant ocular surface diseases, including chronic conjunctivitis, ocular rosacea, cicatricial pemphigoid, graft-versus-host disease, limbal stem cell deficiency, and severe ocular allergy; 2. Received any refractive surgery and corneal surgery before, including corneal transplant; or any eye surgery in the past 6 months; 3. Receiving DED-related medications, including topical steroid eyedrops, topical antibiotics, topical cyclosporin A, and topical diquafosol; 4. Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy in the past 12 months; 5. Received topical antiglaucomatous treatment in the past 12 months 6. Plans to use contact lenses during treatment and follow-up periods or used contact lenses 2 weeks before the baseline measurement and recruitment; 7. Had or currently suffering from severe cardiopulmonary disease, liver and kidney dysfunction, and severe blood system diseases; 8. Suffering from glucose-6-phosphate dehydrogenase deficiency (G6PD); 9. Had or currently suffering from specific respiratory diseases, e.g. emphysema, bronchitis, asthma, chronic obstructive pulmonary disease, bronchial dilatation; 10. Has adverse reaction history to herbs used in this study before; 11. Whose TCM constitution is manifested as "yang-deficiency" or diagnosed by TCM practitioners that their TCM syndrome is not suitable for the atomization treatment; 12. Pregnancy, preparation for pregnancy, or lactation;