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:

  1. Age ≥ 18 years old;
  2. Stable refractive index (refractive index change less than 0.5D in the past 2 years);
  3. The best corrected far vision (CDVA) is 1.0 or better;
  4. 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:

  1. History of eye trauma or surgery;
  2. Suspected keratoconus;
  3. Previously suffering from other eye diseases such as keratitis or edema, glaucoma, uveitis, retinal detachment, macular degeneration, cataracts, amblyopia, etc.;
  4. Preoperative history of severe dry eye disease;
  5. 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

Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK) | DecenTrialz