Analysis of Factors Associated With Threatened Aspiration in Patients Undergoing Small-incision Lenticule Extraction (SMILE) : Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Identify risk factors for progressive suction loss
研究概览
简要总结
The goal of this Prospective observational studiesis to Characteristics of progressive suction loss.
详细描述
The goal of this Prospective observational studiesis to Characteristics of progressive suction loss. The main question[s] it aims to answer are: • Characteristics of people who do not develop progressive aspiration Characteristics of people with progressive aspiration Participants will The differences between the two groups were compared
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years;
- •Stable refractive state in the last 2 years, with yearly change in refractive power ≤ 0.50 D;
- •Spherical power ≤ -10.00D, cylindrical power ≤ -3.00 D;
- •Best Corrected Visual Acuity (BCVA) ≥ 16/20;
- •No use of corneal contact lenses two weeks before surgery.
排除标准
- •Eye diseases or histories beyond myopia and astigmatism, such as keratoconus;
- •Previous eye surgeries or histories of systemic illnesses;
- •Severe mental disorders like generalized anxiety disorder, panic disorder, depression, psychosis, and bipolar disorder, impeding cooperation with the doctor.
结局指标
主要结局
Identify risk factors for progressive suction loss
时间窗: 2024-12-01
Progressive suction loss, the precursors to the loss of suction are quite evident. This study involved reviewing surgical videos and classifying patients into normal and progressive suction loss groups based on diagnostic criteria for progressive suction loss proposed by Huang. The intruding gas, liquid, and conjunctival tissue were analyzed using the ImageJ image processing software. Progressive suction loss was classified into three groups based on severity: Group A, where bubbles and wet spots begin to appear at the contact area between the suction ring and the corneal edge; Group B, where the area of bubbles and wet spots increases, exceeding 5% of the contact area as analyzed by ImageJ, but not spreading to the corneal surface; Group C, where bubbles and wet spots spread to the corneal surface, even affecting the laser scanning area.
次要结局
未报告次要终点
研究者
Yifeng Yu
Deputy Chief Physician of Ophthalmology
Second Affiliated Hospital of Nanchang University