Evaluation of Axial Length Changes Between Pre and Postoperative Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Axial length variability
研究概览
简要总结
The accuracy of IOL calculation relies on the one hand on axial length measurements and on the other hand on corneal and lens thickness measurements.
AL difference in pre and postoperative measurements may be caused by changes of lens parameters.
Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.
详细描述
This is a prospective observational, controlled and unmasked study that would include patients which undergo cataract presurgical examination, after patient signed written informed consent. For each patient only one eye will be included.
In total 50 eyes of 50 patients will be include. Due to missing previous data, the sample size is an approximation.
Prior to surgery, slit lamp examination and cataract grading (LOCS) is performed. Routine biometry is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) for AL and lens measurement.
Additionally, evaluation of tilt and decentration will be performed using Purkinje meter device.
Follow-up examination will be performed three months after surgery and will contain: AL and lens measurement using the two ss-OCT biometery devices, lens evaluation (tilt and decentration of the IOL) using the Purkinje meter. Refractive outcome will be evaluated by determining best-corrected visual acuity and subjective refraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uneventful cataract surgery
- •Age 21 and older
- •Axial length 24.00 mm and bigger
- •CT Asphina 409 M lens implanted
排除标准
- •Intra- or postoperative complication
- •Relevant other ophthalmic diseases that are likely to influence the measurement outcome (as: with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, dens cataract, PEX syndrome, previous ocular surgery or trauma)
- •Pregnancy
研究组 & 干预措施
Axial length variability
Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.
干预措施: Axial length variability (Other)
结局指标
主要结局
Axial length variability
时间窗: 3 months
Evaluation of changes in axial length pre and post cataract surgery using two ss-OCT biometers
次要结局
- Lens tilt and decentration(3 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Head of Department of Ophthalmology, Professor, Principal Investigator, MBA
Vienna Institute for Research in Ocular Surgery