Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease
Trial Parameters
Brief Summary
Evaluate the efficacy and safety of ocular surface microbiota transplantation as an adjunctive therapy for dry eye, and explore its impact on the structure of the ocular surface microbiota.
Eligibility Criteria
Inclusion Criteria: * Dry Eye Patient Group: * Aged 18 to 70 years, male or female. * Meets the diagnostic criteria for moderate to severe mixed dry eye according to the Expert Consensus on Dry Eye (2020), including: * At least one subjective symptom (e.g., dryness, foreign body sensation, burning, fatigue, discomfort, redness, or vision fluctuation). * Fluorescein tear film break-up time (FBUT) ≤ 5 seconds. * Willing and able to actively cooperate with the prescribed course of standard dry eye medications and ocular surface microbiota transplantation therapy for the study duration. * Voluntarily agrees to participate and signs the informed consent form. * Healthy Donor Group: * A family member of a participating subject. * Aged 18 to 50 years. * Normal ocular surface structure and function, with no ocular diseases or related symptoms, and good visual function. Exclusion Criteria: * Dry Eye Patient Group: * History of systemic chronic diseases (e.g., uncontrolled diabetes, autoimmune d