Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Dry eye examination
研究概览
简要总结
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.
详细描述
This study aims to include 160 postoperative 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 FS-LASIK induced DES will also be analyzed, providing new treatment ideas for FS-LASIK induced DES patients and reducing the incidence of FS-LASIK related DES.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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;
结局指标
主要结局
Dry eye examination
时间窗: Preoperative and Postoperative DAY 90
ocular surface disease index
Corneal nerve condition
时间窗: Preoperative and Postoperative DAY 90
corneal nerve fibre length
Sampling of conjunctival sac microbiota
时间窗: Preoperative and Postoperative DAY 90
Microbial diversity of conjunctival sac
次要结局
未报告次要终点
研究者
Yifeng Yu
Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University
Second Affiliated Hospital of Nanchang University