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临床试验/NCT06577012
NCT06577012已完成不适用

Predicting an Opaque Bubble Layer During Small-Incision Lenticule Extraction Surgery Based on Deep Learning

Second Affiliated Hospital of Nanchang University1 个研究点 分布在 1 个国家目标入组 4,678 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,678
试验地点
1
主要终点
The area of patients with opaque bubble layer in the SMILE surgeries

研究概览

简要总结

To explore the prediction of OBL by deep learning model in SMILE surgery

详细描述

The DL model was used to predict the OBL area during SMILE surgery by identifying the corneal full-view images before laser scanning. The DL model developed may assist surgeons to predict the possible OBL area of patients in advance, so as to adjust some surgical parameters and reduce the formation of OBL, which can avoid negative effects on surgeons' operation and patients' postoperative visual recovery, which has important practical significance.

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

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 area of patients with opaque bubble layer in the SMILE surgeries

时间窗: Day 0

The area of patients with opaque bubble layer were observed during the SMILE surgeries.

次要结局

  • ResNet model(Day 0)
  • Deep learning model(Day 0)
  • U-net model(Day 0)
  • Vgg19 model(Day 0)

研究者

发起方
Second Affiliated Hospital of Nanchang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yifeng Yu

Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University

Second Affiliated Hospital of Nanchang University

研究点 (1)

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