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

NCT06448468 | Recruiting DMC

• 1 other identifier: [2024] No. (34).
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Surgery

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

dry group

Non dry eye group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Dry eye patients after FS-LASIK

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

Yifeng Yu

Nanchang, Jiangxi, 330008, China

RECRUITING

Central Study Contacts

yifeng yu

CONTACT

13979180258; 171018170@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 7, 2024
• Study Start: May 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

CN (1)