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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06448468

Enrollment

200

Registered

2024-06-07

Start date

2024-05-01

Completion date

2024-11-01

Last updated

2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Surgery

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame	Description
Sampling of conjunctival sac microbiota	Preoperative and Postoperative DAY 90	Microbial diversity of conjunctival sac
Dry eye examination	Preoperative and Postoperative DAY 90	Tear Film Break Up Time
Corneal nerve condition	Preoperative and Postoperative DAY 90	corneal nerve fiber density

Countries

China

Contacts

Primary Contactyifeng yu

171018170@qq.com13979180258

Outcome results