Analysis of Ocular Surface Microbiota in Dry Eye Patients After Refractive Surgery

Refractive Surgery Clinical Trial

Official title:

Analysis of Ocular Surface Microbiota in Dry Eye Patients After Refractive Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448468
• Other study ID #: [2024] No. (34).
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2024
• Source: Second Affiliated Hospital of Nanchang University
• Contact: yifeng yu
• Phone: 13979180258
• Email: 171018170[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 refractive surgery induced DES, new treatment ideas are provided for corneal refractive surgery induced DES patients, and the incidence of refractive surgery related DES is reduced.

Description:

This study aims to include 160 postoperative refractive surgery 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 refractive surgery induced DES will also be analyzed, providing new treatment ideas for corneal refractive surgery induced DES patients and reducing the incidence of refractive surgery related DES.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Refractive Surgery

Locations

Country	Name	City	State
China	Yifeng Yu	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

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