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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplant group | Active Comparator | Transplant operation to dry eye patients |
|
| Placebo group | Placebo Comparator | Fake transplantation to dry eye patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocular surface microbiota transplantation | Biological | Ocular surface microbiota transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Visual Analog Scale (VAS) for Ocular Discomfort | 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). | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Fluorescein Staining Score (using the NEI scale) | Corneal epithelial damage is assessed by fluorescein staining and graded according to the National Eye Institute (NEI) scale. Each of the five corneal areas is scored from 0 (no staining) to 3 (severe confluent staining). The total score is the sum of all areas, ranging from 0 to 15. A higher score indicates more severe corneal damage (worse outcome). |
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Inclusion Criteria:
Dry Eye Patient Group:
Healthy Donor Group:
Exclusion Criteria:
Dry Eye Patient Group:
Healthy Donor Group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifeng Yu, Ph.D | Contact | +8613979180258 | 171018170@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yifeng Yu | Recruiting | Nanchang | Jiangxi | 330008 | China |
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| Placebo Group | Biological | Fake transplant operation |
|
| At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. |
| Change in conjunctival sac microbiota composition assessed by 16S rRNA gene sequencing | 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*). | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. |
| Result of Schirmer I Test (without anesthesia) | Tear production is measured by the Schirmer I test (without topical anesthesia). A standardized paper strip is placed in the lateral canthus for 5 minutes. The length of wetting is measured in millimeters (mm). A lower value indicates reduced tear secretion. | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. |
| Tear Film Break-Up Time (TBUT) | Tear film stability is assessed by measuring the tear film break-up time (TBUT). 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. | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. |
| Score on the Ocular Surface Disease Index (OSDI) Questionnaire | 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, calculated based on responses to 12 items. A higher score indicates more severe disability (worse outcome). | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. |
| Change in tear fluid inflammatory cytokine levels | 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). | At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention. |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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