Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease

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.

* Inclusion criteria for patients with moderate-to-severe DED were as follows: * (1) age 18-70 years, regardless of sex; * (2) a diagnosis of DED based on the 2016 Asian Dry Eye Society guidelines and the TFOS DEWS II criteria. Moderate-to-severe DED was defined as meeting the DED diagnostic criteria and having at least one of the following: an OSDI score ≥23 (indicating symptomatic dry eye), FBUT ≤5 s, or Schirmer I test ≤5 mm/5 min; * (3) willingness and ability to comply with routine treatment and OSM transplantation during the study period. * (4) Voluntary participation in this clinical study and provision of written informed consent. * Exclusion criteria for patients with moderate-to-severe DED were as follows: * (1) history of chronic diseases; * (2) current or previous eyelid, conjunctival, or lacrimal duct disease; * (3) history of ocular surgery or contact lens wear; * (4) concurrent active infection of the eye or other systemic sites; * (5) history of recurrent viral keratitis or the presence of significant neurotrophic keratitis; * (6) use of systemic medications within the past 2 months; * (7) severe organ disease; * (8) immunodeficiency; * (9) participation in another clinical trial within the past month or current participation in another clinical trial; * (10) allergy to any component of the study device or study reagents; * (11) chronic use of medications or probiotic-containing supplements; * (12) unhealthy lifestyle habits or environmental factors (e.g., smoking or alcohol abuse); * (13) any other conditions considered incompatible with the study. * Healthy donor inclusion criteria were as follows: * (1) Age 18-50 years; * (2) The donor for OSM transplantation was a family member of the recipient and had a consanguineous (biological) relationship with the recipient; * (3) Normal structure and function of the ocular surface, no ocular diseases or related symptoms, and normal visual function. * Healthy donor exclusion criteria were as follows: * (1) infectious diseases such as HIV or hepatitis B; * (2) potential viral or other infections of the ocular surface; * (3) current or previous eyelid, conjunctival, or lacrimal duct disease; * (4) use of systemic medications, antibiotics, herbal medicines, or probiotics within the past 1 month; * (5) pregnancy or any other condition that may affect the study results.