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NCT Number: NCT06448468

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.

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Key information

Conditions

Refractive Surgery

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Sampling of conjunctival sac microbiota

    Time frame: Preoperative and Postoperative DAY 90

    Microbial diversity of conjunctival sac

  2. Dry eye examination

    Time frame: Preoperative and Postoperative DAY 90

    Tear Film Break Up Time

  3. Corneal nerve condition

    Time frame: Preoperative and Postoperative DAY 90

    corneal nerve fiber density

  4. Dry eye examination

    Time frame: Preoperative and Postoperative DAY 90

    Schirmer Ⅰ test

  5. Dry eye examination

    Time frame: Preoperative and Postoperative DAY 90

    ocular surface disease index

  6. Corneal nerve condition

    Time frame: Preoperative and Postoperative DAY 90

    corneal nerve branch density

  7. Corneal nerve condition

    Time frame: Preoperative and Postoperative DAY 90

    corneal nerve fibre length

Study contacts

Contact information is provided by the study sponsor or research team.

yifeng yu

CONTACT

[email protected]

13979180258

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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