Agreement and Variability of Subjective Refraction, Autorefraction, and Wavefront Aberrometry in Pseudophakic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluation of the agreement between the subjective refraction measurements (in dioptres) of two examiners
研究概览
简要总结
Targeting of post-cataract refraction depends mainly on the prediction of the post-operative lens position, but also on the post-operative refraction itself. Hence, aim of this study is to evaluate the agreement and variability of subjective refraction performed by two independent examiners, autorefraction, and wavefront aberrometry in pseudophakic patients after uneventful cataract surgery.
详细描述
One of the main goals of modern cataract surgery, beside removing the cataractous lens, is to achieve the patient's desired post-operative refraction. Targeting this post-operative refraction depends mainly on the prediction of the post-operative lens position and the post-operative refraction itself. Reason for the contributing effect of post-operative refraction in the error-propagation analyses is that refraction in phakic patients was shown to have only moderate reproducibility.
In the past, different studies evaluated refraction methods. However, there is no study that included reproducibility of subjective refraction in pseudophakic patients and compares it with objective refraction methods (autorefraction, wavefront aberrometry).
100 eyes of 100 patients, which underwent uneventful cataract surgery, will be included in the study. Refraction of one eye of each patient will be tested using subjective refraction by two different examiners, autorefraction, and wavefront aberrometry at two separate occasions.
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
- 年龄范围
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age: 21 years
- •Cataract surgery (at least 8 weeks post-surgery)
- •written informed consent
排除标准
- •Complications during or after cataract surgery
- •Ophthalmic diseases, that might interfere with measurements (macular degeneration, glaucoma, diabetic retinopathia)
- •Ophthalmic surgery other than cataract surgery
- •Clinically significant posterior capsule opacification
结局指标
主要结局
Evaluation of the agreement between the subjective refraction measurements (in dioptres) of two examiners
时间窗: 12 months
To show the number of measurements within the limits of agreement, Bland-Altman plots will be created for subjective refraction measurements in dioptres between examiner 1 and examiner 2.
次要结局
- Evaluation of reproducibility between the subjective refraction measurements between two study visits(12 months)
- Evaluation of the reproducibility between measurements done with subjective refraction, autorefraction, and wavefront aberrometry in dioptres(12 months)
- Evaluation of the agreement between the measurements performed by subjective refraction, autorefraction, and wavefront aberrometry (in dioptres)(12 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery