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Clinical Trials/NCT06448468
NCT06448468
Recruiting
Not Applicable

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

Second Affiliated Hospital of Nanchang University1 site in 1 country200 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Refractive Surgery
Sponsor
Second Affiliated Hospital of Nanchang University
Enrollment
200
Locations
1
Primary Endpoint
Dry eye examination
Status
Recruiting
Last Updated
last year

Overview

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 DES, new treatment ideas are provided for corneal FS-LASIK induced DES patients, and the incidence of FS-LASIK related DES is reduced.

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 conjunctival sac will be collected, and changes in the ocular surface microbiota before and after surgery will be analyzed using 16S rRNA sequencing technology. The impact of changes in the ocular surface microbiota on FS-LASIK induced DES will also be analyzed, providing new treatment ideas for FS-LASIK induced DES patients and reducing the incidence of FS-LASIK related DES.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
November 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital of Nanchang University
Responsible Party
Principal Investigator
Principal Investigator

Yifeng Yu

Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University

Second Affiliated Hospital of Nanchang University

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;

Outcomes

Primary Outcomes

Dry eye examination

Time Frame: Preoperative and Postoperative DAY 90

ocular surface disease index

Corneal nerve condition

Time Frame: Preoperative and Postoperative DAY 90

corneal nerve fibre length

Sampling of conjunctival sac microbiota

Time Frame: Preoperative and Postoperative DAY 90

Microbial diversity of conjunctival sac

Study Sites (1)

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