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 range18 Years – 45 Years

SexALL

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;
✕. 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;

What they're measuring

Sampling of conjunctival sac microbiota

Timeframe: Preoperative and Postoperative DAY 90

Dry eye examination

Timeframe: Preoperative and Postoperative DAY 90

Corneal nerve condition

Timeframe: Preoperative and Postoperative DAY 90

Dry eye examination

Timeframe: Preoperative and Postoperative DAY 90

Dry eye examination

Timeframe: Preoperative and Postoperative DAY 90

Corneal nerve condition

Timeframe: Preoperative and Postoperative DAY 90

Corneal nerve condition

Timeframe: Preoperative and Postoperative DAY 90

Trial details

NCT IDNCT06448468

SponsorSecond Affiliated Hospital of Nanchang University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-01

Contact for this trial

yifeng yu

13979180258 171018170@qq.com

View on ClinicalTrials.gov More Refractive Surgery trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexALL

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;
✕. 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;

What they're measuring

Sampling of conjunctival sac microbiota

Timeframe: Preoperative and Postoperative DAY 90

Dry eye examination

Timeframe: Preoperative and Postoperative DAY 90

Corneal nerve condition

Timeframe: Preoperative and Postoperative DAY 90

Dry eye examination

Timeframe: Preoperative and Postoperative DAY 90

Dry eye examination

Timeframe: Preoperative and Postoperative DAY 90

Corneal nerve condition

Timeframe: Preoperative and Postoperative DAY 90

Corneal nerve condition

Timeframe: Preoperative and Postoperative DAY 90