Intraocular Lens Power Calculation Formulas in Eyes With Posterior Corneal Elevation ≥15 µm: An Eyetemis-based Comparative Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- absolute SEQ-PE(accuracy)
研究概览
简要总结
The goal of this observational study is to evaluate the long-term refractive outcomes of advanced intraocular lens (IOL) power calculation formulas in cataract patients with posterior corneal elevation (PCE ≥ 15 μm).
The main question it aims to answer is:
Do PK-based formulas provide superior refractive accuracy compared with Without-PK-based formulas in patients with elevated posterior corneal surfaces?
Participants undergoing routine cataract surgery will have their biometry measured by both Pentacam AXL and IOLMaster 700, and postoperative refraction will be collected at 1 month, 3 months, and 6 months postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the indications for cataract surgery, and undergoing Phacoemulsification + IOL implantation performed by the same surgeon.
- •Preoperative biometry performed with IOLMaster 700 and Pentacam AXL, with a posterior corneal elevation greater than 15 μm within the central 5 mm zone on Scheimpflug imaging, and a central corneal thickness > 500 μm.
- •Surgery completed successfully without any intraoperative or postoperative complications.
- •Postoperative subjective refraction performed at 1 month after surgery by the same experienced optometrist.
排除标准
- •Patients with pterygium, corneal diseases, glaucoma, uveitis, or fundus diseases (such as macular edema, retinal detachment), excluding high myopia.
- •History of ocular trauma or previous intraocular surgery.
- •Occurrence of intraoperative or postoperative complications, such as iris injury, posterior capsule rupture, IOL dislocation, vitreous prolapse, or vitreous hemorrhage.
- •Postoperative best corrected visual acuity (BCVA) worse than 0.
- •Difference between postoperative subjective refraction and preoperative target refraction greater than 2.00 D.
- •Incomplete measurement data.
结局指标
主要结局
absolute SEQ-PE(accuracy)
时间窗: From enrollment to the end of treatment at 6 months
the absolute values of SEQ-PE
SEQ-PE(trueness)
时间窗: From enrollment to the end of treatment at 6 months
Spherical Equivalent Prediction Error 1. SEQ=Sphere+2Cylinder 2. PE=Postoperative Manifest SEQ-Predicted SEQ
Precision
时间窗: From enrollment to the end of treatment at 6 months
Precision refers to the consistency of the prediction errors (PE) of a formula across a study population, indicating how closely the individual prediction errors cluster around the central tendency (e.g., mean or median). A formula with higher precision shows smaller variability in its prediction errors.
次要结局
未报告次要终点
研究者
Shen Weichen
Ophthalmology resident
Second Affiliated Hospital of Xi'an Jiaotong University