Clinical trial NCT06448468: Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK)
Official title: Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Refractive Surgery
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dry eye patients after FS-LASIK

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.

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;

Primary outcomes:
measure: Sampling of conjunctival sac microbiota
timeFrame: Preoperative and Postoperative DAY 90
measure: Dry eye examination
timeFrame: Preoperative and Postoperative DAY 90
measure: Corneal nerve condition
timeFrame: Preoperative and Postoperative DAY 90
measure: Dry eye examination
timeFrame: Preoperative and Postoperative DAY 90
measure: Dry eye examination
timeFrame: Preoperative and Postoperative DAY 90
measure: Corneal nerve condition
timeFrame: Preoperative and Postoperative DAY 90
measure: Corneal nerve condition
timeFrame: Preoperative and Postoperative DAY 90
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Yifeng Yu
state: Jiangxi
Study officials:
References: