Anxiety-related Fixation Instability During Laser in Situ Keratomileusis (LASIK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,435
- 试验地点
- 1
- 主要终点
- The eye-tracking pupil position plot
研究概览
简要总结
Anxiety is common among patients undergoing eye surgery, which is typically performed under topical anesthesia while the patient is awake. This can be an unsettling experience for patients, who may worry about being able to keep their eyes still during surgery, cooperate with the surgical team, and remain immobile in an unfamiliar environment. Patients may also experience anxiety due to concerns about surgical pain, possible complications, and the uncertainty of the outcome of the surgery.
In this study, the investigators aimed to investigate the correlation between the severity of anxiety symptoms during LASIK, and fixation instability during photo-ablation as plotted by the eye tracker.
详细描述
Patient cooperation during LASIK is essential for the surgeon's comfort and predictable results. Fixation instability, which is the inability of the patient to keep their eye still during surgery, is a common problem during LASIK surgery and may lead to unexpected outcomes.
Eye movements occur continually during the excimer ablation. These eye movements can have a large amplitude, a frequency of over 100 Hz, and a corneal speed of around 150 mm/s. With the advancement of scanning-spot excimer lasers, much work has focused on increasing the efficacy of the photo-ablation and smoothness of the ablated surface, especially with respect to the position of the patient's eye by developing state-of-the-art eye trackers to help maintain alignment during photoablation, which can improve refractive outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Candidates undergoing LASIK with
- •Myopia up to 12 diopters
- •Hyperopia up to 6 diopters
- •Astigmatism up to 6 diopters
排除标准
- •Previous corneal surgery,
- •Pregnant or lactating females,
- •Concomitant ocular or systemic disease that contraindicated LASIK,
- •Patients with communication barriers, hypochondria, previous stressful surgical experiences, taking psychotropic drugs, or having a history of any clinically relevant psychiatric or cardiovascular disease.
结局指标
主要结局
The eye-tracking pupil position plot
时间窗: Immediately following surgery
This is a scheme that allows the system to capture the image, process it, and then verify eye position with the next image before releasing the pulse. After treatment, the system releases a summarized treatment report including a plot that depicts various pupil center positions within 3.0 mm off-center (on x and y axes) relative to the eye tracking cameras during ablation.
次要结局
- Heart rate(During and at the end of surgery.)
- Subjective evaluation of patient's cooperation by surgeon:(Immediately following surgery.)
研究者
Mahmoud Abdel-Radi
Principal Investigator
Assiut University