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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractive Surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: yifeng yu; Phone Number: 13979180258; Email: 171018170@qq.com

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330008
      • Recruiting
      • Yifeng Yu
      • Contact: yifeng yu; Phone Number: +8613979180258; Email: 171018170@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Dry eye patients after FS-LASIK

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
dry group
Non dry eye group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sampling of conjunctival sac microbiota	Microbial diversity of conjunctival sac	Preoperative and Postoperative DAY 90
Dry eye examination	Tear Film Break Up Time	Preoperative and Postoperative DAY 90
Corneal nerve condition	corneal nerve fiber density	Preoperative and Postoperative DAY 90
Dry eye examination	Schirmer Ⅰ test	Preoperative and Postoperative DAY 90
Dry eye examination	ocular surface disease index	Preoperative and Postoperative DAY 90
Corneal nerve condition	corneal nerve branch density	Preoperative and Postoperative DAY 90
Corneal nerve condition	corneal nerve fibre length	Preoperative and Postoperative DAY 90

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 2, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: [2024] No. (34).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No