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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

Dry eye patients after FS-LASIK

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: dry group
Group B: Non dry eye group

Trial outcomes

Primary outcomes

1

Sampling of conjunctival sac microbiota

Microbial diversity of conjunctival sac

Time frame
Preoperative and Postoperative DAY 90
2

Dry eye examination

Tear Film Break Up Time

Time frame
Preoperative and Postoperative DAY 90
3

Corneal nerve condition

corneal nerve fiber density

Time frame
Preoperative and Postoperative DAY 90
4

Dry eye examination

Schirmer Ⅰ test

Time frame
Preoperative and Postoperative DAY 90

Secondary outcomes

Other outcomes

Sponsors and contacts

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