跳至主要内容
临床试验/NCT04247152
NCT04247152已完成不适用

Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Needed Correction for Low Toric Lens Correction in Cataract Surgery

Research Insight LLC2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Proportion of Patients requiring Astigmatism Correction

研究概览

简要总结

Examination of the accuracy of toric predictive power in patients with 1.5 diopters of astigmatism or less.

详细描述

Based on preoperative keratometry and using the Baylor Nomogram and a standard factor for surgically-induced astigmatism, the investigators will calculate "keratometry-based total astigmatism" for each patient. This will be compared to "aberrometry-based total astigmatism", i.e. the total astigmatism measured by ORA in each case. With this information the investigators will determine in what portion of patients keratometry-based total astigmatism vs aberrometry-based total astigmatism predicts a need for astigmatism correction, (i.e., total astigmatism is greater than or equal to 0.5 D) during cataract surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who underwent conventional (non-femtosecond) cataract surgery and whose "data to be collected" are accessible and available from the ORA database.
  • Patients whose medical records show they did not exhibit any significant ocular morbidity that would be expected to influence outcome measures.

排除标准

  • Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their visual outcome or ability to be refracted after.
  • Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
  • Patients with previous refractive surgery.

结局指标

主要结局

Proportion of Patients requiring Astigmatism Correction

时间窗: up to 3 months

Proportion of patients requiring astigmatism correction, i.e., having need for astigmatism correction of greater than or equal to 0.5 D during cataract surgery, when measured by preoperative keratometry vs intraoperative aberrometry.

次要结局

  • Patients with Postoperative residual astigmatism 0.5 to 1.0 diopter(up to 3 months)
  • Patients with Postoperative residual astigmatism 1.0 to 1.5 diopter(up to 3 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验