Analyzing eye surface bacteria in patients after LASIK surgery

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

This study is trying to see how LASIK surgery affects the bacteria on the eye's surface in patients, especially those who develop dry eye symptoms afterward.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Nanchang University (Academic / other)
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT06448468 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze the changes in ocular surface microbiota in patients who have undergone femtosecond laser-assisted in-situ keratomileusis (FS-LASIK) surgery. A total of 160 postoperative patients will be divided into dry eye and normal groups based on their postoperative evaluations. The study will collect microbial samples from the conjunctival sac and utilize 16S rRNA sequencing technology to assess the microbiota changes before and after surgery. The findings aim to provide new treatment ideas for patients experiencing dry eye syndrome (DES) induced by FS-LASIK, ultimately reducing the incidence of this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have stable refractive indices and meet specific criteria for postoperative dry eye.

Not a fit: Patients with a history of eye trauma, previous eye surgeries, or systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment options for patients suffering from dry eye syndrome after LASIK surgery.

How similar studies have performed: While the approach of analyzing ocular surface microbiota is relatively novel, similar studies have shown promise in understanding the role of microbiota in ocular health.

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;

Where this trial is running

Nanchang, Jiangxi

• Yifeng Yu — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Study coordinator: yifeng yu

Conditions Refractive Surgery