The 1000 Eyes Lens Power Trial: Introducing Artificial Intelligence to Intraocular Lens Power Calculation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- a new artificial intelligence based approach for intraocular lens power calculation
研究概览
简要总结
The main purpose of the study is to develop an AI approach to improve intraocular lens power calculations.
详细描述
Cataract surgery is one of the most commonly performed surgeries worldwide and has a high postoperative patient satisfaction rate. Despite significant improvement in measurement methods and artificial lens power calculation formulas, miscalculations and subsequently refractive error still occur after cataract surgery.
Most current artificial lens calculation methods use regression formulas. The concept of artificial intelligence (AI) has only recently found use and only in a rudimentary way. Examples include the Hill-RBF calculator and the Ladas superformula, but at least the "superformula" does not use a true AI approach and the results are no better than those obtained with conventional methods.
The main purpose of the study is to develop an AI approach to improve intraocular lens power calculations. The data will be used for the following analysis:
- To compare the new AI method with conventional and modern formula (main question)
- To compare the refractive error for different eye lengths
- To use a ray tracing method to quantify sources of error in patients with a refractive surprise of at least 1.0 diopter
- To evaluate a novel concept of outlier testing using a modified nonparametric Walsh test
This study will be multi-center and partially prospective. Data from 1000 patients who have already had cataract surgery will be analyzed.
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
- 21 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pseudophakic (at least one eye): cataract surgery between 4 weeks and 24 months prior to recruitment
- •If both eyes would be suitable for the study only the right eye will be included, if only one eye is suitable for the study, this eye will be included
- •Pre-operative swept-source OCT biometry available (no ultrasound measurement for axial eye length)
- •Uncomplicated cataract surgery
- •Age 21 years and older
排除标准
- •Multifocal IOLs
- •Combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery)
- •Best corrected distance visual acuity below 0.5 Snellen
- •In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
结局指标
主要结局
a new artificial intelligence based approach for intraocular lens power calculation
时间窗: 2 years
Developing an artificial intelligence algorithm to predict post-operative refraction
次要结局
未报告次要终点