Dry Eye
Conditions
Keywords
Ocular surface microbiota transplantation, Dry eye, Adjunctive therapy, Preliminary study
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.
Detailed description
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.
Interventions
BIOLOGICALOcular surface microbiota transplantation
Ocular surface microbiota transplantation
BIOLOGICALplacebo transplantation Group
placebo transplantation operation
Sponsors
Second Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Visual Analog Scale (VAS) for Ocular Discomfort | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. | The severity of ocular discomfort (e.g., dryness, pain) is assessed using a 100-mm Visual Analog Scale (VAS). Participants mark their level of discomfort on a line from 0 mm ("no discomfort") to 100 mm ("worst imaginable discomfort"). The score is the distance measured in millimeters (mm). A higher score indicates more severe symptoms (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Corneal Fluorescein Staining (tCFS) | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. | A fluorescein sodium strip moistened with sterile saline was applied to the inferotemporal conjunctival sac. The subject was instructed to blink several times, after which the tear film was examined under a slit lamp using cobalt blue light. tCFS was graded according to the modified National Eye Institute (NEI) scale. The stained cornea was divided into five zones (central, superior, temporal, nasal, and inferior), each scored on a scale of 0 to 4. The individual zone scores were summed to obtain a total score (range, 0-20). |
| Change in conjunctival sac microbiota composition assessed by 16S rRNA gene sequencing | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. | Microbiota from conjunctival sac swab samples is analyzed using 16S rRNA gene sequencing. Key outcomes include: 1) Alpha diversity change (Shannon Index, unitless), where a higher index indicates greater microbial richness and evenness; 2) Beta diversity change (Weighted UniFrac distance, unitless), measuring compositional shifts between samples; and 3) Change in relative abundance (%) of specific bacterial taxa (e.g., \*Corynebacterium\*, \*Pseudomonas\*). |
| Schirmer I Test | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. | The subject was instructed to close the eyes, and timing was started immediately. After 5 minutes, the strip was removed and the length of the wetted portion was measured. The length of wetting is measured in millimeters (mm). A lower value indicates reduced tear secretion. |
| Fluorescein Break-Up Time (FBUT) | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. | Tear film stability is assessed by measuring the tear film break-up time. After instillation of fluorescein, the time interval between the last complete blink and the first appearance of a dry spot on the cornea is recorded in seconds (s). A shorter time indicates greater tear film instability. |
| Score on the Ocular Surface Disease Index (OSDI) Questionnaire | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. | Symptoms related to dry eye disease and their impact on vision-related function are assessed using the Ocular Surface Disease Index (OSDI) questionnaire. The total score ranges from 0 to 100. A higher score indicates more severe disability (worse outcome). |
| Change in tear fluid inflammatory cytokine levels | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. | Levels of inflammatory cytokines in tear fluid samples are measured using a multiplex immunoassay (e.g., Luminex assay or ELISA). The concentration of specific cytokines (e.g., IL-1β, IL-6, IL-8, TNF-α) is reported in picograms per milliliter (pg/mL). An increase in concentration indicates a higher level of inflammation (worse outcome). |
Countries
China
Outcome results
None listed