Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Nomogram Predicting and Related Influencing Factors to Surgical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Diopter
研究概览
简要总结
The goal of this observational study is to learn about the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design and the influenced factors of refractive outcomes in patients who underwent Small Incision Lenticule Extraction(SMILE) at the Refractive Surgery Center of Tianjin Eye Hospital. The main questions it aims to answer are:
- Compare the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design
- Analysis the influenced factors of refractive outcomes
详细描述
In this ambispective observation study, to compare the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design and Analysis the influenced factors of refractive outcomes, patients have been continuously recruited and the data can then be used for further case-control and cohort studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years and older
- •Stable refraction over the past 2 years
- •Corrected distance visual acuity (CDVA) of 20/25 or better
- •Soft contact lens discontinued 2 weeks or longer
- •Rigid contact lens discontinued 4 weeks or longer
排除标准
- •Abnormal corneal topographic features
- •Severe dry eye
- •Active keratitis
- •Corneal scars
- •Keratoconus or suspected keratoconus,
- •Retina diseases
- •History of intraocular or corneal surgery
- •Pregnant or lactating women, required chronic systemic corticosteroids or immunocompromised subjects were also excluded from this study
结局指标
主要结局
Diopter
时间窗: 3 months after small incision lenticule extraction
Spherical Diopter, cylindrical diopters and axis by Manifest Refraction Test
Uncorrected Distance Visual Acuity (UDVA)
时间窗: 3 months after small incision lenticule extraction
Corrected Distance Visual Acuity (CDVA)
时间窗: Before small incision lenticule extraction 3 months after small incision lenticule extraction
次要结局
- Aberration(3 months after small incision lenticule extraction)
- Corneal Tomogram(Before small incision lenticule extraction and 3 months after small incision lenticule extraction)
- Corvis ST Test Result(Before small incision lenticule extraction and 3 months after small incision lenticule extraction)