Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-sit… (NCT06448468) | Clinical Trial Compass
RecruitingNot Applicable
Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK)
China200 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sampling of conjunctival sac microbiota
Timeframe: Preoperative and Postoperative DAY 90
2
Dry eye examination
Timeframe: Preoperative and Postoperative DAY 90
3
Corneal nerve condition
Timeframe: Preoperative and Postoperative DAY 90
4
Dry eye examination
Timeframe: Preoperative and Postoperative DAY 90
5
Dry eye examination
Timeframe: Preoperative and Postoperative DAY 90
6
Corneal nerve condition
Timeframe: Preoperative and Postoperative DAY 90
7
Corneal nerve condition
Timeframe: Preoperative and Postoperative DAY 90
Trial details
NCT IDNCT06448468
SponsorSecond Affiliated Hospital of Nanchang University
. 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;