Ocular Surface Microbiota Alterations Following FS-LASIK and Their Association With Postoperative Dry Eye.
Jingjing Xu, Chiwen Cheng, Kang Yu...
https://pubmed.ncbi.nlm.nih.gov/41788695Actively Recruiting
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID06448468
Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK)
Led by Second Affiliated Hospital of Nanchang University · Updated on 2024-07-31
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the changes in the ocular surface microbiota in patients who have undergone femtosecond laser-assisted in-situ keratomileusis (FS-LASIK) surgery. The study focuses on understanding how these microbiota changes relate to dry eye syndrome (DES) caused by FS-LASIK. By analyzing these changes, new treatment ideas for patients with FS-LASIK induced DES may be developed, and the incidence of this condition might be reduced. The study will include 160 postoperative patients divided into two groups: those with dry eye and those without. Microbial samples from the conjunctival sac will be collected before and after surgery. The ocular surface microbiota changes will be analyzed using 16S rRNA sequencing technology to evaluate their impact on FS-LASIK induced DES. Participants will undergo dry eye examinations, conjunctival sac microbiota sampling, and corneal nerve condition assessments before the surgery and on postoperative day 90. Researchers will track these measurements to understand the relationship between microbiota changes and dry eye development after FS-LASIK. The total participation duration includes preoperative and 90 days postoperative evaluations to monitor outcomes and collect relevant data.
CONDITIONS
Brief Title
Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK)
Who Can Participate
Age: 18Years - 45Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Stable refractive index with less than 0.5D change in the past 2 years
- Best corrected far vision (CDVA) of 1.0 or better
- For postoperative dry eye patients: OSDI score of 13 or higher plus at least two of the following: tear film rupture time 10 seconds or less, Schirmer I test 10mm or less, corneal fluorescein staining with more than 5 spots
You will not qualify if you...
- History of eye trauma or eye surgery
- Suspected keratoconus
- History of other eye diseases such as keratitis, edema, glaucoma, uveitis, retinal detachment, macular degeneration, cataracts, or amblyopia
- Preoperative severe dry eye disease
- Systemic diseases like hyperthyroidism or autoimmune disorders
- Severe mental disorders such as anxiety or depression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Up to 1 day before surgery
Participants undergo preoperative assessments including dry eye examination, corneal nerve condition evaluation, and conjunctival sac microbiota sampling.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo FS-LASIK surgery and immediate post-operative observation.
1 visit (in-person)
Long-term Monitoring
Duration - 90 days
Participants are monitored to assess changes in ocular surface microbiota, dry eye symptoms, and corneal nerve condition 90 days after surgery.
1 visit (in-person) at Day 90
Trial Site Locations
Total: 1 location
1
Yifeng Yu
Nanchang, Jiangxi, China, 330008
Actively Recruiting
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Research Team
Y
yifeng yu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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