Identification of Factors Related to Unintended Initial Dissection of the Posterior Plane in Small Incision Lenticule Extraction Cases by Three Different Surgeons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,003
- 试验地点
- 1
- 主要终点
- The number of patients with unintended initial dissection of the posterior plane in the SMILE surgeries
研究概览
简要总结
To explore the potential factors for unintended initial dissection of the posterior plane in a large sample retrospective analysis and surgeons of different levels.
详细描述
Myopia is the most common eye disease in the world. Femtosecond laser small incision lens extraction (SMILE) has increasingly become the first choice in refractive surgery due to its greater biomechanical stability, less impact on the tear film and other advantages. However, because SMILE surgery is more challenging than flap-based corneal ablative surgery, young surgeons sometimes dissect the lenticule posterior plane first in clinical practice, which will make it more difficult to extract the lenticule or even cause the retained lenticule. The purpose of this study aims to explore the potential risk factors for unintended initial dissection of the posterior plane in large samples and surgeons of different surgical volumes and different surgical habits (different angles of peripheral corneal incision) in multiple scenarios.
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
- 是
入选标准
- •A condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 D when ocular accommodation is relaxed;
- •Age ≥18 years;
- •Spherical equivalent (SE) ≥ -10.0D;
- •Corrected distance visual acuity (CDVA) ≥ 16/20;
- •Stable myopia for at least 2 years;
- •No contact lenses wearing for at least 2 weeks.
排除标准
- •The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
- •A history of eye surgery;
- •The presence or history of systemic diseases.
结局指标
主要结局
The number of patients with unintended initial dissection of the posterior plane in the SMILE surgeries
时间窗: Day 0
The number of patients with unintended initial dissection of the posterior plane were observed during the SMILE surgeries.
次要结局
- The impact of peripheral corneal incision angle on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries(Day 0)
- The impact of lens diameter on the unintended initial dissection(Day 0)
- The impact of spherical equivalent on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries(Day 0)
- The impact of peripheral lens thickness on the unintended initial dissection(Day 0)
- The impact of central corneal thickness on the unintended initial dissection(Day 0)
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