Evaluation of Two Different Intraocular Lens Models After Lens Implantation Using the Yamane Technique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- uncorrected visual acuity
研究概览
简要总结
In case of instability or rupture of capsular bag occurs during cataract surgery, Yamane technique is one of the options to fix intracocularlens' haptics. Yamane technique uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel.
Aberrations, IOL tilting or even dislocations might occur and influence the final outcome of IOL implantation.
The aim of this study is the evaluation of the postoperative tilt of Kowa PU6AS using Yamane technique. Furthermore of the corrected and uncorrected visual acuity and the anterior chamber depth are being developed.
详细描述
During uncomplicated cataract surgery, an intraocular lens (IOL) is implanted into the patient's capsular bag. If increased instability or rupture of this capsular bag occurs due to aggravated intraoperative conditions or IOL dislocation, several options are available to the surgeon to correct the aphakia, all characterized by their respective advantages and disadvantages, but with no clear superiority of any one method.
The popular Yamane technique, or "flanged IOL fixation", uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel using two 30-gauge needles.
Examples of lenses used for this purpose are the TECNIS ZA9003 (Johnson&Johnson, USA) and the Kowa PU6AS (Kowa, Japan). Another approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with lack of capsular stability.
All types of implantation are not immune to aberrations, tilting or even dislocation. Many factors influence the final outcome of IOL implantation, be it the optimal choice of intraocular lens power, the surgeon's experience regarding fixation in more challenging eyes, or individual anatomical conditions. As part of quality assurance, an evaluation of monthly and six-monthly data will now be performed. The aim of this study is the evaluation of the postoperative tilt of the Kowa PU6AS in Yamane technique, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management.
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
- •Minimum age: 21 Years
- •planned or performed lens implantation using the Kowa PU6AS or the Johnson & Johnson ZA9003 using the Yamane technique
- •signed patient consent form
排除标准
- •best corrected visual acuity >0.1 (Snellen)
- •pregnancy
结局指标
主要结局
uncorrected visual acuity
时间窗: 6 Weeks
Measurement performed by experienced staff
Tilt
时间窗: 6 Weeks
Postoperative Tilt
Autorefraction
时间窗: 6 Weeks
Refraction using an automated refractor
Subjective Refraction
时间窗: 6 Weeks
Refraction performed by experienced staff
Best corrected visual acuity
时间窗: 6 Weeks
Measurement performed by experienced staff
次要结局
未报告次要终点
