Status:
RECRUITING
Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK)
Lead Sponsor:
Second Affiliated Hospital of Nanchang University
Conditions:
Refractive Surgery
Eligibility:
All Genders
18-45 years
Brief Summary
By using 16S rRNA sequencing technology to analyze the changes in ocular surface microbiota before and after surgery, as well as the impact of changes in ocular surface microbiota on FS-LASIK induced ...
Detailed Description
This study aims to include 160 postoperative patients, who will be divided into a dry eye group and a normal group based on postoperative dry eye examination. Microbial samples of the patient's conjun...
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old;
- Stable refractive index (refractive index change less than 0.5D in the past 2 years);
- The best corrected far vision (CDVA) is 1.0 or better;
- Postoperative dry eye patients need to meet the following criteria: Patient's Eye Surface Disease Index (OSDI) ≥ 13 and two of the following three criteria are met: Tear film rupture time (BUT) ≤ 10S Schirmer I test (mm/5min) ≤ 10mm, corneal fluorescein sodium staining exceeding 5 spots;
Exclusion Criteria:
- History of eye trauma or surgery;
- Suspected keratoconus;
- Previously suffering from other eye diseases such as keratitis or edema, glaucoma, uveitis, retinal detachment, macular degeneration, cataracts, amblyopia, etc.;
- Preoperative history of severe dry eye disease;
- Patients with systemic diseases, such as hyperthyroidism or autoimmune diseases; Or severe mental disorders, such as anxiety and depression;
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06448468
Start Date
May 1 2024
End Date
November 1 2024
Last Update
July 31 2024
Active Locations (1)
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1
Yifeng Yu
Nanchang, Jiangxi, China, 330008